Antibiotics To Get Warnings Over Tendon Damage
95 CommentsBy Ed Silverman // July 8th, 2008 // 1:57 pm
The FDA wants to add Black Box warnings to several antibiotics used to treat bacterial infections, including Bayer’s Cipro and Johnson & Johnson’s Levaquin, over concerns the meds cause tendonitis and tendon rupture. The move comes six months after Public Citizen sued the agency to require the warnings on the drug labels.
The antibiotics are in a class known as fluoroquinolones, which are sold by various drugmakers under different brand names, and currently carry warnings about the risk of tendon ruptures, although not the Black Box that is the most severe alert to be required by the FDA. Here is the agency statement, which notes the risks are greatest in those over 60 years old; kidney, heart, and lung transplant recipients, and when used in conjunction with steroids.
An unspecified number of serious reports of tendonitis and tendon rupture continue to increase with use of the drugs, according to the agency, which adds that the often involve the Achilles tendon, but also include ruptures of the shoulder, hand, biceps, and thumbs. As a result, the FDA wants the drugmakers to create medication guides to be given to patients.
UPDATE: In a statement , Sid Wolfe of Public Citizen says the FDA isn’t going far enough. “The FDA is silent on our request that it also send a warning letter to physicians clearly describing possible adverse reactions, such as tendon pain, so that patients can be switched to alternative treatments before tendons rupture.
“We are troubled that the FDA is not doing everything within its power to prevent more people from needlessly suffering disabling tendon ruptures. Nothing could be simpler and more effective than a letter to doctors in addition to what the FDA has proposed.”
Betty Evans
I am 75yr old white woman who has been fighting Crohns disease since age 42. I have had three bowel resections. After taking different meds I was started on cipro alternating with levaquin each month. I did feel better after several months. Bet I had a lot of trouble with my Rt Knee. I thank you for the information on tendon pain. I never said anything to my doctor because I frequently have joint pain that doesn’t last very long. My knee has hurt a lot for many months.
I am a retired RN and still learning.
Thanks, Betty
Kathy Lewis
Betty,
I’m also aternate with these two drugs for urinary infections. I was recently told I have a frozen shoulder. But I have been having pain in my left knee for no reason.
Thanks,
Kathy
poppy
I took Levaquin in December. My tendons did not rupture but I will forever have Tendinopathy from my neck to the middle of my back and down both arms and hands. It is horrible. I wish I had information of the “possible rare and uncommon side effects” before or even during the time I took it. My damage is irreversable. My quality of life is destroyed. I can not pick up a glass of water to take a drink. I am only 36. I have been told that the drug company will not be held responsible for destroying my life. They followed the FDA regulations. They knew the potential hazards and hid them. Why can they knowingly ruin my life and not be responsible?
david fuller
The FDA was fully advised about this reaction in 1996 when Public Citizen filed a petition seeking black box warnings as well as dear doctor letters. Such ruptures had been associated with this class since 1982. The FDA did nothing. In 2005 the Attorney General of the State of Illinois filed a petition seeking these same warnings as well as (again) Public Citizen in 2006. The FDA FAILED to review these petitions as required by law and Public Citizen SUED them in Federal Court (January 2008) as a result. But such ruptures are the least of the patient’s concerns. More than half of these drugs have been removed from clincal practice due to severe toxicity issues, permanent injuries such as irreversible peripheral nueropathy, and numerous fatalities. Yet the FDA ignores all of this, continues to approve new drugs in the class as well as new indications for those already in use. All of which are devoid of any meaningful warnings. We have been fighting with the FDA for over a decade now with little to no success to demand adequate warnings for these drugs. Those who have suffered such injury only have the FDA to blame. They know full well the horrendous safety profile of this class and continue to hide it from the patient and the treating physicians. Those who have an interest in reading the more than 4000 medical journal entries, case reports, ect are invited to log unto http://www.fqresearch.org
Justin
I have a primary, genetic immune deficieny (Hypogammaglobulanemia) and have taken Levaquin for years to help with recurring bacterial infections. I can barely walk due to the pain in BOTH of my achilles tendons. It comes and goes, but I think I maybe be able to tie it very closely to when I have been on Levaquin. I am 35 and very active, so I thought that it was just normal tendonitis, or my shoes or whatever. I just finished a lengthy round of Levaquin for a sinus infection and I haven’t been able to run a single yard in over a month due to the pain and swelling in my heels! I can only pray that once this stuff gets out of my system that things will return to “normal” for me. Surely there is a class action suit looming in the distance……
Laurie
Sadly, this reaction has been documented for years, but rarely has the information been passed along to patients.
Helen
I was poisoned by this drug in 2004. My life was changed forever. The dr that prescribed it to me never warned me of what could happen and neither did the pharmacy.
Tendon problems are just the tip of the iceberg. I have central nervous system damage, hearing loss, tinnitus, anxiety, insomnia etc. etc. Please send MedWatch reports to the FDA. It took years for them to admit that tendon damage was related to the antibiotic, but we can’t give up until this poison is off the market so that others won’t have to suffer like we have.
Deathby Cipro
I too have a ‘constellation’ of symptoms that I developed from a week of taking Cipro in 2006, including tinnitus, visual distortions, insomnia, chronic fatigue, generalized pain, anxiety and severe depression, peripheral neuropathy, in addition to the muscular and degenerative bone issues. The first ENT I saw wrote it off to Meniere’s disease. Dozens of doctors and thousands of dollars of tests later, they write it off to depression and anxiety except for the documentable degenerative bone loss that shows up on CT scans. No prescription has helped with the insomnia or depression and actually makes it worse. No supplement or food makes it better. Eating makes me feel sick. I was a healthy 52 year old before this, but every day only gets worse. Yes, none of these symptoms are fatal, nor will any doctor put me in a hospital for treatment (except for depression, which has been untreatable). The original doctor who prescribed this medicine for me can’t explain why I have severe constipation and all sorts of GI problems after her colonoscopy. But no cancer. Yet. The FDA needs a person to read the data - or perhaps the data isn’t getting recorded - but one thing is for sure - if people read blog entries like these, someone should wonder what is going on with these quinolones.
farmer
Two in our family have been dealing for years with disabling injuries from these drugs tendon,joint,muscle,ocular,neuropathy. We were never warned. For those who think they only have tendonitis a test done by a Neurologist called small fiber skin punch biopsy,may actually reveal damage to small fiber nerves peripheral neuropathy).
FDA should issue Dear Doctor letters immediately about all the issues since they have known about them for years.
Seena Darwish
I took 3 doses of Levaquin 2 months ago, and I am still suffering from multiple joint and tendon pain. The pain started AFTER I stopped the drug. I’ve also had neurological and central nervous system symptoms. I am 34 yrs old, yet feel 50 years older. This drug is DANGEROUS!
Sally
I was poisoned by Avelox, a fluoroquinolone drug in 2004 and though I did not have a tendon rupture, I am forever changed. I have constant joint pain, short term memory loss, severely impacted energy levels. My hands have become misshapened and painful making it difficult to do my job.
The first two years post-avelox were hellish with tremors, burning pain and inability to function.
These drugs should be reserved for life and death situations- not for someone with a sinus infection or bronchitis, which was my condition.
I am unable to exercise without incurring a good 2 weeks of recovery. I am unable to concentrate and remember simple things from one minute to the next.
I was perfectly fine before the Avelox.
The Black Box warning should ALSO include the central and peripheral nervous system damage! It’s destroyed my life!
Sally in Ct
Rose McNierney
People can have delayed reactions to these drugs. My symptoms did not become apparent until two weeks after finishing my prescription of Levaquin. Because of these delayed reactions, many patients and their physicians are not connecting the symptoms to the drugs. This results in severe underreporting of adverse events to the FDA. Maybe now that this issue is getting media attention, people will be able to make the connection between their symptoms and the fluoroquinolones. This class of antibiotics is very very dangerous and should only be used as a last resort. At the present time these medications are used to treat simple and ordinary infections. I was treated with Levaquin for pneumonia in December. Seven months later I am still suffer from many adrs including neuropathy and muscular/joint pain.
Elizabeth
I took Levaquin in October of 2006. I did not have tendon ruptures, but I did have joint and muscle pain and weakness. In December of 2006 I seperated my cervical spine from my cranium just from stretching one morning.
I had a plethora of other symptoms, some of which left me bedridden for 4 1/2 months. I had anxiety, sleep problems, nerve attacks with which I would twitch, jerk, and yell out uncontrollably. I had orthostatic hypotension, palpitations, severe digestive problems, my endcocrine system got hit, spawning all sorts of problems like hypothyroid, hyperthyroid, hyperglycemia, hypoglycemia. (I had problems with these things before, but the Levaquin made them much worse.) I lost quite a bit of hair, suffered depression, and the list goes on.
This class of drugs is poison and nothing but. I am glad for the black box warning, for whatever reason the wretched FDA decided to call for it. I am given to understand that when a drug is ‘black-boxed’ doctors are far more likely to NOT prescribe it. I certainly hope this is true.
E.
teri
I think it’s great to see more publicity about fluoroquinolone side effects. Many doctors forget that patients have a right to be informed about side effects, or perhaps doctors are not informed of side effects well enough to have intelligent conversations about them with their patients. I had a conversation with my doctor about possible side effects of Levaquin before I took it, and my doctor never mentioned tendon disorders, and convinced me to take the Levaquin since it’d be no problem for me to switch to a different antibiotic if I did have side effects. Or so we both thought.
Luckily my mom came across a publication by Public Citizen that talked about tendon damage by fluoroquinolones when I was 7 days into my 14+day course of Levaquin. I’d been wondering why my achilles were so sore and my calves so rock hard. Four years later with continued tendon and nerve pain, I’m still regretting that initial assumption that side effects go away when I quit ingesting the pills. But if this is what the result of 7 days of Levaquin is like, thank goodness for that article by Public Citizen that kept me from taking 14 days worth of pills. I am a formerly healthy, active 35 year old (31 when I took Levaquin).
Rocky Adams
I hope this new warning is just the beginning of a complete and unbiased evaluation of this class of antibiotics. I realize that some of the drugs in this class might have use as a last resort in certain serious infections that are resistant to all other forms of treatment, but I believe the way the fluoroquinilones are currently used is just unethical based upon the knowledge we currently have regarding the extensive scope of side effects as well as the possibility of permanent injury. Also has anyone factored in the millions of dollars of medical treatment and pharmaceutical costs that the side effects of this antibiotic is costing the government as well as the insurance companies along with average consumers? I mean doctors seem to act as if tendon injuries and tendon ruptures just repair themselves. A tendon rupture generally requires expensive surgery as well as long term rehabilitation along with all sorts of other testing and drug prescriptions. So these fq antibiotics which are prescribed for simple things like a uti or a sinus infection then turn around and cost the American consumer and insurance companies millions in costs to repair the damage they cause. And yet it seems the average American doctor cares little for this factor nor does anyone ever mention it. I think its time the FDA examine this class of antibiotics further to see if this is another cigarette industry type case where we are all being harmed financially by these drugs even if we lucky escape the actual side effects.
Christine
I took 3 doses of Levaquin and my life has been hell. I can hardly walk with the pain in my achilles. Noone told me about this. I would NEVER had taken it. I had a bladder infection that I could of been giving something else. I also have pain in my fingers.,wrists,etc. The worst is the legs. I am sad that I am unable to do fun things with my family. And having another baby right now does not look good. Levaquin and the FDA robbed me. I wish Dr learn what posion that they are handing out.
Leslea
I am part of the medical community and have been for almost 30 years, I would recommend that all medical staff wake up and look at their facility’s antibiograms before prescribing a quinolone, the oath “to do no harm” dictates that you do just that. The quinolones should only be used in a life or death situation and not routinely, there are other effective antibiotics out there. Also you will be preventing from these antibiotic from becoming ineffective from resistance when the life and death circumstance arises and they are needed.
I am not some hysterical victim, but an intelligent colleague and am suffering from 4 and 1/2 long adr to Avelox. I suffer from unrelenting pain due to myofacial damage in my right shoulder and hip. The muscles are in perpetual painful knots that I seek therapy on twice a week, just to be able to walk and type. The pain is just one of the multiple system damages that I have. I have severe depression, short term memory loss, periphereal neuropathy, vision impairment,constant fatigue from battling the depression and pain, etc. My life will never be the same, I have been informed that the hip muscles are permanently damaged and that the periphereal neuropathy is not going to resolve itself either. So a once very active intelligent person can barely walk or stand for more than a few minutes and has to leave theirselves note after note to remember thing. My life is forever changed, please don’t casually write prescriptions for quinolones, don’t do this to anyone unnecessarily.
Melody
Has anyone here done a Google search for “cipro anthrax”? Food for thought: If terrorists could not/did not kill us with air-borne anthrax, our current “leaders” stood ready with stores of taxpayer-purchased Cipro to cure or cripple us.
Jim Witte
I read somewhere that tendon damage was “rare” side effect of statins.. Lots of people are on statins - so how are they to know that the damage is due to the antibiotics and not the statins? Unless they are willing to give us the raw data to prove that the damage occurred ONLY in the patients on both drugs and not in statin patients only, or if the fluoroquinolones cause the risk to go up significantly.
That said, I’ve read rather bad things about the fluoroquinolone class (can’t remember what exactly). But haven’t these drugs been around for a while?
“We are troubled that the FDA is not doing everything within its power to prevent more people from needlessly suffering disabling tendon ruptures. Nothing could be simpler and more effective than a letter to doctors in addition to what the FDA has proposed.”
What else they could do would (although it would be neither simple nor cheap) would be to fund basic research to figure out *why* tendons are rupturing. I’d bet a small sum that it has something to do with the fluorine atom that I assume in in a fluoroquinalone, and if statins are involved, I’d bet a slightly larger amount that CoQ10 in involved somehow. If there are alternate pathways for CoQ10 biosynthesis, I’d be looking quite hard at mutations in those pathways - do people who have alternate pathways (ones not connected with actyl-CoA-reductase) that don’t work as well more affected? If so, there’s your (partial) answer.
There was some antibiotic or other a few years back that was pulled because it caused a small number of liver failures. Should it have been pulled? Yes. Should they have figured out *why* the liver failures occurred? Yes. It was quite a small group as I recall, so there is might be some relatively simple mutation that was responsible. Figure out the what it is, and we learn something that might just turn out to be useful in the future.. Mind you, I have no idea how you go about looking for what may well be a 2 or 3 nucleotide needle in a 3 billion base-pair haystack.. And I’m a futurist.
david fuller
Jim,
The mechanism of action is well documented within the medical journals and this does indeed affect people who are on NO other drug.
There is absolutely no question whatsoever that this class is toxic to soft tissue particularly tendons and has been documented as such since 1982. For more than two and one half decades. All the questions you are asking have been answered decades ago, long before satin drugs even came into being. This class has been crippling people since 1962 to be exact when Nalidixic Acid was first introduced. The pharmcore that all the quinolone drugs are based upon are derived from this drug. It is called the quinoline ring.
These drugs have been well documented to have a profound affect on celluar DNA as well as direct toxicity. We know what the problem is, we know how it comes about, and we know that for the most part it is irreversible. Any other questions you may have we have already answered a long time ago. You can find the answers on http://www.fqresearch.org where we have been documenting this for almost a decade now.
Kim Bean
I am a 43-year-old woman. In December of 06, I was prescribed Levaquin and then Avelox. I took them for a total of 17 days. Within 24 hours, I felt like I was in a fog. Within two days, I was awakened from a sound sleep with severe muscle cramps in my thighs. My leg pain was excruciating. I was also experiencing electrical and burning sensations all over. I called my doctor. She didn’t tell me to stop taking my antibiotic. I continued to take it, never attributing my pain to an antibiotic. Over the next 6 months, I developed tendonitis in every possible tendon in my body. As a professional pianist and piano teacher, I couldn’t practice the piano for 2 months. I couldn’t teach for a whole month as I could barely hobble around. I couldn’t drive a car due to the pain in my calves, thighs and knees for 6 months. I couldn’t walk 20 yards without my legs giving out. I couldn’t even rest my foot on the floor for more than a minute because of the pressure on my tendons. I had to constantly keep changing my position from sitting, to standing, to lying down. I had muscle twitching all over and severe insomnia for about 5 months. I had terrible night sweats, but could never get warm during the day. I lost 13 pounds within 2 weeks. I spent over $3000.00 on medical tests to rule out everything from Celiac’s disease to neuromuscular diseases and Sjogren’s syndrome. Of course, you can imagine the anxiety over the thought of having a disease like ALS. Gradually, I began to get better. Nearly 2 years later, I have mostly healed. However, I do continue to get tendonitis if I am not careful. I workout daily, as this seems to help ease the arthritis I now have. However, I have to be very careful to not over do it. I have nerve pain in my shoulder and neck that isn’t getting better. My husband, an MD, was ashamed that he didn’t recognize the symptoms and stop me from taking the drug. He and I both just want doctors to inform patients and recognize these reactions. If I had only known within the first 24 hours to stop taking the drug, I probably wouldn’t have had such a severe reaction.
Ty Taylor
I was a healthy 42 year old male who took Levaquin for a sinus infection. The same day as the Black Box Warning was issued; I was having my third tendon reattachment surgery. I have to wait at least 6 weeks before I can undergo yet a fourth tendon rupture reattachment. At least it takes my mind of the Achilles Tendinopathy, joint pains, headaches, uncontrolled muscle twitching etc. I consider myself one of the lucky ones since so far it has not affected my kidneys, liver, heart, eyes and other side effects that many are dealing with from this class of drugs. I would urge a real journalist to take the time and look at the real number of cases. The Fda numbers are misleading. The clinical data coming from other counties are showing much higher rates of tendon ruptures and other life threatening side effects.
Laurie
“The Fda numbers are misleading”
I have no doubt they are very undereported since most would never make the association between an antibiotic and ruptured tendons.
Todd Plumb MD
Fluoroquinolone antibiotics have damaged many people. I know of this severe damage on a personal level since I suffered such and adverse reaction to the fluoroquinolone antibiotic Levaquin myself 22 months ago. Since then I have had daily pain and disability of my nervous and musculoskeletal systems and for several months had endocrine and gastrointestinal problems as well. The disability and damage caused by fluoroquinolones is long term and may gradually escalate in that more severe problems such as worsened neuropathy, neuromuscular disorders, musculoskeletal disorders and endocrine disorders once initiated by the fluoroquinolones may develop with a delayed and insidious progress.
This progression of the fluoroquinolone toxicity syndrome is well know by its sufferers and not recognized by health care givers. There has been no investigation in to the reactions. This lack of attention stems from of an antiquated FDA reporting system and the under-representation of the seriousness and frequency of the adverse reactions. The makers of fluoroquinolones have no interest in investigating adverse reactions when doing so will hurt them financially. It is only recently with the weight of litigation pressing down that the FDA has published its incomplete and grossly inadequate boxed warning about the potential for fluoroquinolone toxicity.
I have met many other patients suffering from the adverse effects of fluoroquinolones. Many of them reside in my community including 3 physicians and more than twenty patients.
Although these drugs may be life saving in certain infections when less toxic antibiotics may fail, they have been promoted for use as first line treatment for sinusitis, and urinary tract infections, and are often given indiscriminately to unsuspecting patients by uninformed and cavalier physicians for such benign illnesses as the common upper respiratory infection. Unfortunately for many patients they are trading a mild short term medical problem for a serious long term one.
Sincerely,
Todd Plumb MD
Karen Fisher
I was a healthy 42 yr old mother of three with a doctorate that I worked very hard to get. After taking 4.5 days of cipro for a simple UTI, I couldnt work for almost 3 months and I lost my practice. I suffered tendinosis, very painful, head pressure, vasculitis, peripheral neuropathy, tachycardia, and countless other adverse affects.
It is 7 mos later and I am still suffering. There is no cure or treatment, just try to figure out a way to deal with the loss of function and ability to care for my children and to continue my career.
All this is robbed from me. I now have multiple tumors over my body which I did not have before. I dont know what my future is now. I could have had a wonderful life. Now I look through tear filled eyes all the time.
Gary Boyles
The number of side effects and the seriousness of these side effects caused by this class of antibiotics is grossly underrated and under-reported. Tendon damage is only one of the many injuries these drugs inflict on thousands of people each year. The delay in time between taking these drugs and having the adverse reactions present can be what has concealed the high number of reactions. Most Dr’s do not even realize that the tendon, nerve, joint, muscle and CNS injuries that their patients develop after taking Fluoroquinolones is related to this class of antibiotic.
The true number of people affected each year by these antibiotics is astounding and has been well hidden by the manufacturers. There are thousands of people that have been permanently crippled and hundreds of thousands more that have suffered the ADR’s of Fluoroquinolones for months to years.
These ADR’s are not uncommon at all.
I was a normal healthy 51 Y/O male that was prescribed Cipro for a uncomplicated UTI. I was not given a risk vs. benefit warning first by my Dr. When I told him that Cipro had caused severe ADR’s, he refused to file a Medwatch or FDA report as I asked him to. He told me he would no longer treat me and I was asked to leave. I was treated like a criminal because I complained that Cipro had given me bad side effects.
I can only say that this Black Box warning is way overdue and still doesn’t cover many of the other severe and disabling side effects these drugs inflict on otherwise healthy people.
Rick Radcliff
My reaction to avelox started almost three months after I took the drug for a sinus infection, in March, 2005. I did not have the muscloskeletal problems that many have, but I had the vision problems, extreme fatigue, dehydration, brain fog and short term memory loss, neuropathy, and tinnitis. Some of these ADRs stay with me today.
The medical community simply does not acknowledge the danger of fluoroquinolones. In 6 months of going from specialist to specialist, no one could tell me what was wrong with me because nobody is looking for ADRs to drugs in their diagnostic paradigm. And because they’re not, people are being mis-diagnosed.
I feel this is nothing short of a health crisis in this country. These drugs are causing major damage to people and incur great cost to our health care system. In my case, I had probably 30K worth of useless tests. Chronic Fatigue Syndrome and Fibromylgia are possible results of fluoroquinolone ADRs. I know that FQ ADRs mimic arthritis in older people. FQs have been known to cause diabetes. And the list goes on.
Black box warnings should include the FULL SPECTRUM of the ADRs assocoated with these drugs. The FDA is only cutting their losses with this warning in response to a lawsuit by Public Citizen. The FDA should insist on Dear Doctor letters in the USA like there are in Europe. But the FDA is not protecting the citizens of this country; that much is evident.
Laura Calderon
I was misdiagnosed with a kidney infection and began taking Levaquin (500mg once per day) in September 2006. On the 5th day I had to stop taking the medication due to severe shin pain and Achilles tendon pain. I began to have difficulty walking. Over the next several months new symptoms appeared including severe muscle twitching in my legs and feet, painful aching in legs, heart palpitations (for three weeks I had arrythmias for 3-5 hours every day), severe brain fog, paresthesia in feet, toes, fingers, and face, rash on arms, severe shoulder and hip tendonitis, severe insomnia, body vibrations and dysthesias, chills, depression, dizziness, itchy torso, anxiety, panic attacks, tinnitus, eye twitches, GERD, severe neck and shoulder pain, head pressure, tachycardia, burning soles of feet, anorexia with loss of 17 pounds over 5 months, mood changes, crying jags, popping joints, arthritic like pain in fingers, hip sciatica (diagnosed by Rheumatologist), vertical nail ridges, tender scalp and migrating pain (moving from one area of the body to another), horrible headaches, internal tremors, blurry vision. I had not had any of these symptoms prior to taking Levaquin. I began taking Ativan to sleep and ease the anxiety and became addicted to it for 8 months. I was lucky to be on a sabbatical when the symptoms were the worst, otherwise I would have had to take a leave of absence. I spent so much time being tested by different specialists (referred by the primary care physician) for cancer, MS and other neurological disorders. After 22 months I still have many of these symptoms. Levaquin has brutally altered my quality of life.
Matthew Lake
On my 23rd birthday I started ciproI only took 3 doses of cipro in total before realizing what was happening… I went from being a very healthy 23 year old male who was athletic for over 10 years doing Karate, Yoga, Football, Judo and other sports, I eat an extremely healthy diet, no bad foods at all, and generally take care of myself in everyway possible, I have never drank alcohol and never smoked… I have all the blood tests and other tests to prove how healthy I was. After taking the ciprofloxacin my life completely changed in an instant, for months I had to crawl around my house beacuse of the pain in my achilles tendons. I noticed the side effects approx two hours after taking cipro… however my doctor told me to carry on taking it! (I stopped myself after 3rd dose).
After my very first dose of cipro I had a cascade of symptoms that I never experienced in my life before such as; Bilateral Achilles tendinitis, Tendinitis in both wrists, Chronic insomnia where it would take 5 hours to fall to sleep then I would be waking up every 1 hour and this continued for 4 months. What is interesting is that I have never had insomnia in my life before cipro. I also experienced chronic nightmares, moderate peripheral neuropathy (burning, tingling, numbness), constant body tremors, dry eyes, dry mouth, dry skin, pulsating sensation in my stomach/neck/hands, pulsatile tinnitus, tinnitus (4 noises), muscle pains, joint pains. Eye flashes, blurry vision, eye floaters, static/snow vision, inability to adjust from light to dark (right eye), twitching, dizziness, stiff neck, head pressure, eye pain, ear pain, difficulty swallowing, aspiration, GERD, lack of appetite. I also had massive increase in spider veins, nail ridges, constant wrinkled fingers, nail growh abnormalities… and my skin become thinner around my body (breakdown of collagen?).
It has been 9 months now since I had my reaction and I still cannot function properly because of my tendinitis… about 80% of my symptoms have lessened or have now gone away. I am improving at a very slow and frustating rate. How can I go from being extremely healthy and having just a minor infection to not being able to function and feeling like I had aged 50 years in one night. I have lost thousands of pounds in earnings and have not been able to work consistently since my reaction.
I have seen literally thousands of people in the same position as me, a significant portion of them were healthy and young like me, and now are disabled. How can the true devestation of this class of antibiotics be revealed if things like tendon damage does not show for months after the last dose? I feel the numbers reported are probably very small because people are not associating antibiotic use with tendon problems, and other problems as I mentioned above. From the moment I took the antibiotic I had a cascade of symptoms that never stopped showing up until about 4 months post-cipro. From there I healed from most of it but now have several injuries which are likely to be with me for life, or until medicine can fix them. I just want my life back, and for doctor to prescribe quinolone drugs when only absolutely needed
Nathan
Does anyone know the mechanism believed to be involved in tendon damage?
Brenda
Hello,
Thank you so much for writing. I don’t feel so alone anymore. I was
begining to think I was loosing my mind.Because no one had an explanation for
my pain. I had a kidney transplant 16 year’s ago and I had been off and on
Cipro for the first 10 year’s due to infection and phenominia and other
thing’s due to transplant. I have had many episodes of gout through them
year’s . And 6 year’s ago my husband took me to the hospital because I
could not breathe I was diagnoised with phenominia and was transported to
St.Louis U in St.Louis Mo on May 13th 2002 and I bairley remember getting into
the emergency room and nothing until one day I woke up and seen people walking
by my door of the room I was in .I got out July 4th .
And did not understand why the Dr has not came in and seen me yet or they had
and I just did not remember it because it was daylight and It was night when I
got there. Well I seen my hand’s where straped to the bed and I could not
move them. I yelled for a nurse and yelled and no one came. There was a pan at
the end of my bed so I kicked it and then they came running in my room.
I ask them to undo my hand’s and they said they couldn’t and I ask
why not .They said they did not want me to get out of my bed I said I won’t
if they undo me.They wouldn’t.Come to find out I had been in a coma for 5
1/2 week’s and did not know anything about it.
They undone my hand’s and I felt my hair and it was long and my ponytail
was matted feeling. And I had a red ponytail holder whenI went in and I had a
yellow one in then.So I could not figure out why.I had to have my hair cut off
because it was so mangled. and I had to take therpy to learn how to walk again.
I tryed to eat and I couldn’t hold a fork I shook so hard I couldn’t
even eat. I had lost 25 pound’s and I had scars on my chest and I ask why
they said I had tubes all in and out of me. I even was entabated three
times’.I had just gotten married for the second time and I didn’t even
know who my husband was….I can not to this day remember a lot of things in my
life and have a hard time remembering things from one minute to the next.
I was in the hospital in 1997/98 I can not remember the year exact. And my
left foot was so swollen and would not go down and the pain was so bad.They was
going to remove my left foot if it did not go down some by the next day.Well
luckly it did and I guess it was gout so bad and from the antibotic I also
almost lost me foot.
Well when I left the hospital from the coma I have been on Cipro 500 mg
everyday for 6 year’s.I have been to Dr after Dr to try and find out why I
have so much pain all over my body.It is getting so bad I end up in bed more
than out of bed.I am on Hydrocodone 500 mg and a tylenol does more good I have
been on them for 4 year’s due to hip pain so bad.And I guess my hip’s
are ok or they would have replaced them by now.I have a headache everyday,I
have loss of appitite,I have had a ringing in my ear’s for two year’s
now.It never goes away.My eye’s are awful my glasses do not last long
enough to get a new apir.I can not sleep over 6 hour’s if that at all.I
have had hive’s for the last 5 year’s I have been to dermatoligist
anfer another and they can not figure what is all over my skin it drive’s
me nut’s it itche’s so much/I scratch until I bleed.
My body hurt’s so bad I lay in bed and thinkif I was paralized at least I
wouldn’t feel the pain.
I have gout,I bruise so easy and I have become a bleeder. I can not remember
a lot of thing’s. So if there are a lot of mistakes it is due to me not
remembering how to spell.Or not knowing what I have done. I can not remember a
lot of thing’s I have had seizures so bad in the hospital they said I shook
the bed and still have small ones and ontwo med’s for them.The Dr’s said
they had my children call the family in when I was in a coma they did not ezpect
me to make it through one day. But by The Grace of God I did. So is there any
way you can tell me how to deal with this. I hurt so bad sometime’s I wish
I was dead. And it is all because of a medication I was justtaking to try to
stay alive.Because the Dr’s told me the next time I got phenominia will
probally kill me. So please help me somehow. Thank you Brenda
Connie Aud
“FDA Orders Black Box Warning On Antibiotics” I have a problem with these warnings. I believe them to be misleading as well as being totally insufficient. This is based upon my personal experience from watching my husband become disabled throughout the years. Mentioning people over 60 as the higher risk of having a tendon rupture is just 1 thing I have a problem with. I believe people younger than 60 had the most reported ruptures. My husband was in his early 40’s when he had his first rupture. I believe every age group is at risk taking these medicines. “Rare occurrence of tendinitis & tendon ruptures can occur while or AFTER” is something else that I believe is misleading. How many people know that AFTER means much more than a few weeks. My husband took Cipro & around 11 months AFTER he had a rupture. He took CiproXR & around 11 months AFTER his tendons started to rupture again. AFTER means quite a bit more than a few weeks. I have another problem with reading “physicians should warn their patients of the risks”. Who’s going to warn the physicians so that they can warn their patients? My husband saw almost a dozen different doctors & not 1 of them associated his 6 ruptures to Cipro. They had no idea what caused this. Tendons aren’t the only things that can rupture. Muscles can rupture also. These ruptures have occurred with no warning that anything was wrong. There are also “other” severe adverse reactions. Thinking that tendonitis & tendon ruptures is the only thing you have to be concerned about taking these medicines is wrong. Dear Doctor Letters SHOULD be sent to every single doctor along with more clarity on the issues like “after”, “age group at risks” , & “all the adverse reactions”.
cbs
took 28 pills of 500 mg levaquin in July 2001. My life has not been the same since. The drug (as confirmed by several doctors including mayo clinic) caused tendon damage all over my body, extensive peripheral neuropathy, vision damage, hearing damage, insomnia, severe fatigue, night sweats, non stop 24/7 muscle twitching in several areas, muscle weakness and numerous other issues. I was a very athletic individual and active participant in the lives of my two young children. That all changed in July 2001. Seven years later, I have improved greatly, but it took 4.5 years to really see the healing begin. Even now, the tendons in my feet, knees and shoulders are still too damaged to allow me to play most of the sports I once loved including tennis, racquetball, running, baseball, etc.
Stay away from this drug unless it is the ONLY option to keep you from dying.
Shelley Sealover
Every morning when I open my eyes, I awaken to this nightmare. There is a “sickness” that feels like my body has been poisoned. My hands and feet are swelled and sore…my entire body is stiff and painful…heart-palpitations, vibrations throughout my body…ringing in my ears…bleeding specks of sores on my skin…and a full, bloated feeling in my gut…I feel like I should be dead. It is only by the grace of God, and the love of my 2 children that I am able to pull myself up out of bed, and make it painfully down the stairs. Crying will do no good, as I know I must be strong to fight this horrendous ordeal that has become my life. Knowing that there are others who are living this nightmare gives me a sense of strength…and compassion. There are no more words to described what we are going through emotionally, let alone physically. How could something so unbelievably criminal have happened to us?? And why is this insanity being allowed to continue?? How many more innocent people will have their lives destroyed…how many more must suffer…how many more must die….before something is done?? Someone tell me, what will it take??
Diagnosed w/ arthralgia, trigeminal neuralgia, tendinitis both elbows, enlarged lymph nodes…
still seeing doctor after doctor, and specialists who can only treat the “symptoms”, not the cause.
The Black-Box warning for tendon damage is hardly sufficient and long-overdue.
The poisons that robbed my children of a mother were AVELOX and LEVAQUIN…20 pills. I traded a sinus infection for this life of pain and misery.
~Shells~
Sally
In December 2004 I was prescribed Avelox, a fluoroquinolone antibiotic for a sinus infection and bronchitis.
I immediately became very ill. I couldn’t get off the couch. As days went on, I began to get pains throughout my body. Then the fasciliations began and the tremors throughout my abdomen. In the insuing weeks, the tremors moved into my extremities. Then the excruciating, burning pain began.
I ended up in the ER twice, had extensive blood tests, Brain MRI’s, Cat Scans, and the list goes on to rule out MS, Lupus, Lyme and a host of other diseases. All came back negative. All this began after ingesting the avelox. There is not a doubt in my mind that Avelox poisoned me; that I suffered Central nervous system damage and peripheral neuropathy. It has been 3 1/2 years since this event and I still suffer peripheral pain and short term memory loss.
The first year was wrought with insomnia, anxiety and pain. I thought my life was over. Thankfully my reaction was not as severe as others who have been poisoned by these antibiotics. Nonetheless, my reaction has changed my life. My memory is forever damaged. My hands are in constant pain. My work is hindered. And I feel like it’s taken years off of my life.
In my experience, I found very little support from doctors. One neurologist at a major Ivy League medical school believed me and had seen the damage from fluoroquinolones before. But he confessed that he was at a loss how to treat my conditions other than to just treat the pain with pain killers and the anxiety with ativan.
I want more than anything to prevent anyone else from suffering these horrendous adverse effects. These drugs need more than tendon ruptures mentioned in the Black Box. The Black Box needs to mention the CNS damage and the peripheral nerve pain, the excruciating anxiety, as well as a laundry list of other effects suffered by a multitude of victims like myself.
We need a voice! We need support! And we need to be believed!
Sally
Justice in MI
To Nathan’s question, there are some speculations about mechanism in a reasonably good review article that can be accessed at
http://www.journals.uchicago.edu/doi/pdf/10.1086/375078
But they remain hypotheses.
James K
I was given Cipro almost 3 years ago. I was to take for 30 days for an infection that I did not even have. I lasted 17 days. The pain in my legs was so bad-that I could hardly walk.
Now days I can walk some but still have lots of pain. A tendon ruptured in my right little finger.
The quinolone family of drugs are prescribed like candy and most doctors refuse to acknowledge these ADRs. It is amazing to me how medical professionals will believe a drug company rep–who has a vested interest in getting these drugs prescribed–than listen to a patient that is going thru a living hell–because of the ingestion of these drugs. The moron that prescribed the cipro to me–accused me of wanting to sue him. I have become a total cynic of the medical profession–mainly because most doctors consider their careers over the health and safety of their patients.
Carlo
I took exactly 2500 mg (10 pills of 250 mg) of ciprofloxacin over a period of 5 days in the summer of 2007 .
Because of Cipro I need a wheelchair now.
I’ve always been a healthy person. I took part in squash, tennis, football and jogging. T
After taking the third pill the first signs started. I had joint and muscles pain in my calves and arms. Because it was on saturday I did not call my doctor. I did read the paper in the box of Cipro and it did not say to stop immediately. If I did stop I would have less problems. Damned why don’t they warn us better.
On monday I went to my doctor and he said it was from Cipro but he thought it would not harm to go further. He did not know what to do.
MY SYMPTOMS IN ORDER OF APPEARANCE
Joint pains
Calves/Achilles Arms Hamstrings Shoulders
Muscle pains
Increased joint stiffness
Dry ears
Dry eyes
Dry mouth and nose
Insomnia
Numbness feeling right foot
Joint popping all over my body
Dry sinus
Ear pain
Red skin after touching it / pressure on it
It is almost a year after taking Cipro.
I cannot walk because of pain in calves and Achilles.
I need a wheelchair out of my home.
I hope time will heal the joints in my calves and Achilles. My lower legs are my main problem. I really hurts when I try to walk.
David
At age 46 I was given 750 mg of Levaquin for 21 days to combat epidytimitis in 2007. I had some
mild side effects during the course of treatment, ie… mild insomnia, mild joint aches, and some skin itching. After finishing my course of treatment I have developed more severe muscle and joint aches and pains
along with muscle weakness. Alot of my joints, especially my knees and wrists became very frail and prone to easy damage.
At a year out I have experienced Severe joint pain (especially of the knees and leg muscles), weakness in the
arms and neck, never-ending neck pain (constant muscle strains and pains), insomnia, anxiety, depression, dryness and vision issues with left eye, and various peripheral neuropathies. I have had periods of
no symptoms followed by strong relapses (cycles).Prior to this adverse drug reaction I was very healthy and bicycle 7-10 miles a day. I have never regained the ability to aerobic exercise and have to constantly guard against joint damage.
John
Aching ankles (tendons), pins & needles, loose stools, twitching and aching muscles, fatigue, anxiety, depression. Some symptoms didn’t start until several weeks after stopping the medication.
I took Cipro for 10 days in 1997. The fatigue, anxiety, and depression still bother me. Most doctors don’t know about these severe side effects and unfortunately probably won’t believe you if you tell them. The drug companies put sales ahead of concern for the patient. This results in a largely unrecognized danger of long term suffering when you take a quinolone (cipro, levaquin, etc.) antibiotic. Please help protect your family and friends by making this information know.
m wood
I’ve had severe arm and shoulder pain for over 1-1/2 years, since a bout of Bronchitis treated with Levaquin in early 2007. MRI, orthopedic surgeon and neurology consults, chest X-ray, two nerve conduction tests, electrical stimulation 24×7 for months, physical therapy, more drugs - more antibiotics, steroids and Nsaids in high doses - which intensify the fluoroquinolone effects - and even accupuncture (I hate needles and have a low a low tolerance for pain, so that was a huge leap for me) and rest whenever possible gave little relief but time seemed to help. Then the second bout of Bronchitis a year later and a huge relapse. I asked the doctor if the drugs could be the problem since the arm pain was so much worse following Bronchitis both times. The answer - NO, probably the coughing aggravated my neck and affected the nerves. That was in February 2008. I could tell stress made the symptoms worse. I quit my job in April to rest and get better. Early June, I had a UTI, took Cipro, and had an arm spasm so bad my hand cramped and distorted after my 6th pill. Reread the warnings and saw the tendon rupture in small print. Stopped the drug and hit the web. I can’t believe it was the drugs all this time. I did additional research through my medical records and realized that two previous cases of ankle “sprains” with unknown causes, one leading to my using a cane for six months in my 30s, were also related to dosings of this drug family. And tendon issues are just one of the many severe side effects that patients need to be warned about.
Rocky Adams
In January 2008, I was 37 years old, married with 3 kids under six and in reasonable good shape considering I had had a partial elbow replacement in September 2006 from a fall. That took a real downward turn once I went to my doctor for what I thought was a sinus infection. At the visit the doctor without doing any test wrote me a prescription for ciprofloxin, which I had never heard of and definitely never used before. Of course I filled said prescription only to be somewhat surprised when I read in the warning that this was a drug used for anthrax infections. Like a good patient, I started the medication even though its strength concerned me only to have burning pain in my surgically repaired elbow and my achilles tendons at which time I called my doctor per the instructions on the medication warnings. The doctor totally ignored my complaints, saying they had nothing to do with the meds and told me to keep taking the cipro. Once again, I did what my doc suggested only to have increased tendon/muscle pain over the next two days and finally found myself having an anxiety attack after 8 cipro tablets. I stopped the medicine and made an appointment with my doctor. For the two days I had to wait to see my doctor, I was in bed with terrible anxiety, severe muscle/tendon pain/weakness and all sorts of neurological issues like brain fog, neuropathy,and spatial proximity distortion that I had no knowledge of before taking this drug. When I did go to the doctor he acknowledged that cipro could have rare side effects but didnt think my issues were caused by the medication and told me to give it a month to see if everything went away and if not come back and we would start running tests to discover my real problem. I left feeling both betrayed and scared , because my doctor of the last fifteen years had basically disregarded all my issues. So I have struggled for six months by myself trying to fix these side effects. At present I still cannot say I am 100% back to normal again. Each day has been a day to doscover what side effect I will have today. One day I will have severe tendon pain/tightness then that will resolve and brain fog will creep up then that resolves only to have burning neuropathy plague me for a few hours or days. The side effects from these drugs are exactly that nothing short of a modern day plague. No one acknowledges they exist and no doctor that I have seen has any idea what to do for them except to ignore them or to blame them on another disease, yet every day I have to deal with them as best I can.
anonymous
The quinolones are used largely because of bacterial resistance to less powerful antibiotics. And much of that resistance was driven by consumers DEMANDING antibiotics for minor, probably viral, illnesses, such as otitis media. Doctors aren’t prescribing Levaquin for sinusitis because of the reps, they are doing it because it works. You always have the option of not treating a bacterial infection, so long as you are willing to live with possible long-term complications such as rheumatoid arthritis and pneumonia.
And why wouldn’t a prudent person stop taking a medication if sudden, severe symptoms develop?
Laurie Reylek
I was a healthy, vibrant and active 27 year-old wife and mother when I was prescribed Cipro on September 25, 2007. I stopped after the third 500 MG pill after a “guardian angel” friend helped me connect the insomnia and severe headache I was experiencing to the Cipro….within 24 hours of discontinuing the Cipro symptoms intensified and multiplied. I experienced severe neuropathy all over my body, tachycardia, insomnia (not one minute of sleep for over two weeks), profuse sweating, inability to stop pacing, psychosis, loss of appetite, metallic taste in my mouth, mouth sores, dizziness, tendon pain, joint pain, extreme weakness in every muscle of my body especially my jaw, high blood sugar readings, inability to focus my vision on objects, eye floaters, and many more. After this acute stage subsided I have since gone on to develop vertigo (bad enough at times that turning over in bed induced vomiting), severe jaw pain, treatment-resistant hypothyroidism, inability to digest food and extreme stomach pain, atonic colon, skin that will not heal, multiple food and chemical sensitivities broken capillaries all over my body/face, weight loss, extreme fatigue, and a disabling skin reaction to any amount of UV light, and I look like a deflated balloon…there are more but my memory has been affected as well. If I had been given adequate risk/benefit warnings regarding taking this drug I would have absolutely opted to take another antibiotic instead. This drug has ruined my life, and robbed my children of their mother and my husband of his wife. There is not one aspect of my life that hasn’t been affected by those three Cipro pills taken almost 10 months ago. My brief experience with conventional medicine is officially done….if there is one thing that I am grateful for from going through this experience it has taught me that without exception no pharmaceuticals can be trusted, and I will never put my life and health in the hands of conventional medicine again
John
The dangers of fluoroquinolone drugs go far, far beyond tendon ruptures and have been known for a long time. Their toxic reactions include irreversible neuropathy and other neurological and soft tissue damage, endocrine complications, and psychosis. The list is a long one. And their occurrence is greater than we, and perhaps even doctors, are led to believe. And we risk these serious and often permanent reactions for what? A sinus infection? A simple UTI? A “boo-boo”? In my own personal experience even doctors, themselves seem to be too busy, lazy, or careless to even know much about the drugs they prescribe or even read the patient insert. The Black Box for tendon ruptures is “nice” but is late and hardly scratches the surface of recognition and education required for these drugs.
david fuller
The statement that quinolones are used largely because of bacterial resistance to less powerful antibiotics simply is not true. They are prescribed without any thought as to what bacteria is causing the infection, or even if a bacterial infection is even present to begin with, without a second thought.
And much of that resistance was driven by consumers DEMANDING antibiotics for minor, probably viral, illnesses, such as otitis media. Wrong again, such resistance is a DIRECT RESULT of the wanton scripting of these drugs. The scripting abuse is rampant and is driven by the manufacturers who relentlessly promote these drugs for anything and everything. The FDA has nailed these manufacturers over an over again for false advertising.
Doctors aren’t prescribing Levaquin for sinusitis because of the reps, they are doing it because it works. So does taking out an ant hill with shotgun, but no thought is being given to the resulting collateral damage. You always have the option of not treating a bacterial infection, so long as you are willing to live with possible long-term complications such as rheumatoid arthritis and pneumonia. Not ONE person who had made a comment so far stated that one is NOT to treat a bacterial infection. They have all stated that the severe adverse reactions to this class, which are far more horrendous than rheumatoid arthritis and yes, even pneumonia, as they have killed a considerable number of patients in the same manner as untreated pneumonia, requires that it be a drug of last resort when all else fails.
Treat the infection with the proper drug, at the proper dose, for the proper duration, and choose from the any number of antibiotics with a reasonable safe profile first. If all else fails then use a fluoroquinolone. But NOT as a first line agent for everything under the sun. Use a little common sense first.
And why wouldn’t a prudent person stop taking a medication if sudden, severe symptoms develop? Because their ignorant doctor tells them over and over and over again that the drug could NOT POSSIBLY be to blame for these symptoms, and using the same assine scare tactics that you are employing, scolds them into continuing.
I take no offense to you posting your point of view, everyone is entitled to an opinion. But yours is frivolous and therefore in desperate need of a rebuttal based upon facts, rather than the false propaganda of the drug companies.
Even with our obivious disagreement here, I absolutely cannot fathom for a nanosecond why you would possibly disagree that everybody wins with full disclosure. Scripting abuse, and as a result, bacterial resistance, drops dramatically. The patient is not at risk of having their lives destroyed, and the fluoroquinolones would continue to be a viable option for severe and life threatening infections. Any other use is simply criminal considering this proven safe profile. And the manner in which they are currently being employed in light of this horrendous safety profile is out and out medical malpractice. And for the FDA to continue to allow this continue for over forty years now is criminal gross malfeseance.
Justice in MI
Unfortunately, we have to do our own titrating. I have refused fq treatment from the first time one was rx’d for me. There were obviously safer options for the relevant infections - my docs agreed when I raised the question. How did I know? I read the label and asked.
Nathan
David fuller writes: “yours is frivolous and therefore in desperate need of a rebuttal based upon facts”
That’s interesting David, because you didn’t include ANY facts in your rebuttal. Please include some primary references, some real numbers, etc next time you want to discuss FACTS.
you write:
“such resistance is a DIRECT RESULT of the wanton scripting of these drugs”
I agree partially. Such resistance would happen naturally even under light scripting. It would just happen more slowly.
you write:
“The scripting abuse is rampant and is driven by the manufacturers who relentlessly promote these drugs for anything and everything.”
You provide no evidence for this. Is this just your gut feeling? Doctors want to make patients feel better. Many are temped to write a script for an antibiotic “just in case” it might be bacterial in nature. I’ve not heard of a shred of evidence that pharma has pushed antibiotics for non-bacterial diseases. I have heard of LOADS of cases of mothers wanting their kids to be treated with SOMETHING to cure the dreaded sickness that their child has.
This tactic of “blame the drug company for everything” has to stop. There are three parties involved: The drug company, the doctor, and the patient. They all share responsibility for ensuring appropriate treatment.
Nathan
David writes: “And for the FDA to continue to allow this continue for over forty years now is criminal gross malfeseance.”
It’s a good thing that the FDA can’t be sued. They seem to be hated almost as much as the pharma companies.
Once again, this is a risk-benifit analysis: The rate of this tendon damage is estimated to be approximately 1 in 10,000 scripts. A couple of points:
1) This would NEVER be picked up in a clinical trial. One would only observe this after YEARS on the market.
2) Given such a low rate, a given doctor would probably only observe 1 or 2 cases of this side effect durring his/her entire career. They would be unlikely to make the correlation on thier own.
Chris
“Even with our obivious disagreement here, I absolutely cannot fathom for a nanosecond why you would possibly disagree that everybody wins with full disclosure.”
To David Fuller -
The people who do not win with full disclosure are the drug companies and drug reps who have reduced sales due to declining prescriptions when these drugs are moved to second-line therapy.
ddk
I took 10 doses of 500 mg. of levaquin 10 years ago.
Within 3 days my brain felt like it was buzzing like an arterial-venous shunt but when I went to the doctor at that time, I was told it would all disappear once the antibiotic was finished. No one took it to be serious. I still have trouble focusing, memory problems, cognitive problems and dizziness. I became progressively worse at a relatively fast rate, muscle/joint pain and weakness, severe gastrointestinal problems (which have only become worse), constant fatigue, just to name a few problems. Some people do get better, unfortunately many don’t. I was given it with the words, “it’s a great drug that’s very safe”. My life ended as I knew it and I’ve not been able to be productive since. In addition, I was denied disability because nothing could be found wrong on the tests during those first years.
Namid
The black box warning about tendon ruptures is a good start, but many more symptoms have to be included like damage to the liver, CNS system, heart… and it must be underlined that the symptoms do not only last during the treatment but that they can stay for a long time or even forever – in my case since 20 years and there is no end in sight. I only took 1 pill Floxin.
What shocks me is that the doctors, who describe these drugs, are not properly informed by the manufactures about the real toxicity and ADRs of the fluoroquinolones. In addition to this the medical class ignores, if a patient shows up with ADRs and is able to connect it directly with the treatment with this drug.
For me it was a battle every day, because it damaged the blood-brain-barrier, which protects the brain. Now substances can enter and cause big damage similar to stroke or brain tumor. I have the feeling that a mouse is eating up my brain bite by bite and it takes away slowly but steadily many of the normal skills and my personality. In order to protect my brain I have to isolate myself and I have to avoid all exposures.
Namid
AA
Nathan, I wanted to respond to your point about doctors not recognizing side effects due to what you claim is a low rate of these occurrences.
In my opinion, that is irrelevant. There was a survey recently that when people reported what were very commonly known side effects of anti-cholesterol meds, they were blown off.
Until doctors change their mentality and recognize that mysterious symptoms can be due to meds, we will deal with the same issues whether the side effect rate is .000001% or 100%.
Come on, what does a doctor need to know when a patient comes in with tendon damage who didn’t enagage in sports’ activities and the only thing that had changed was they were put on a med? I realize you have to rule out other possibilities but assuming that is done, how can you then blow off the med as many commentators have reported their doctors doing?
By the way, as someone who was told that the tinnitus and hearing loss I developed from Remeron was falsely due to Meneire’s, I had to sarcastically laugh when I read a similar type comment regarding these meds. That must be the boiler plate language for doctors who get patients who develop ototoxicity from these meds. Sorry for my sarcasm but that greatly angers me.
Anyway Nathan, no matter how you spin the issues, there is no justification for blowing off the side effects that were reported. As one who has suffered greatly from med side effects (not as much as sufferers of the antibiotic drugs), I am really getting tired of your excuses.
Not that I wish ill will on anybody but I think if god forbid, you or a member of your family suffered an adverse drug side effect, you would see things differently.
I had better stop here.
AA
AA
Correction - The tinnitus I developed was from Wellbutrin XL and Doxepin. The hearing loss was still from Remeron
Lou
Flouroquinolones antibiotics (Levaquin, Cipro, Avelox) can be very dangerous. It’s imperative to understand the potentially insidious side effects and that research be spent on finding a cure.
I was a healthy 43 year old male. 12 days of Levaquin has changed my life. I had never had a side effect from a medication. This dangerous drug is in a different league.
My side effects from Levaquin include a deep ache in thigh, disabling tendon issues across achilles, groin, elbow, etc. I have tingling, numbness sensations, and muscle twitching. I need crutches now to walk, and some days cannot walk at all. This is my life now because of Levaquin.
While the black box warning issued by the FDA is a start, it doesn’t go nearly far enough in describing the seriousness nor the scope of the side effects.
It’s time to recognize the facts and not rationalize them away. Let’s not have more tragedies.
Justice in MI
Public Citizen’s Health Research Group has been warning about fq’s since 1996.
Their petition to get the current black box, and a summary of their efforts, can be accessed at:
http://www.citizen.org/publications/release.cfm?ID=7453
I do not necessarily follow HRG recommendations, but - again unfortunately - I do believe pts have to inform themselves much more than we imagine. Here are a few of my own guidelines:
- Take nothing without reading the label, most obviously, warnings, precautions, contraindictations, and interactions.
- Do not assume that because something is not on the package insert it is not a problem. Do a thorough search of reliable sites for evidence of potential AEs not listed.
For me, this includes PubMed, HRG, Therapeutics Initiative, the Medical Letter, and a few other sources. The point is to find as close to evidence-based, unspun, and unsuppressed info as possible.
With preemption coming, this is even more critical. It will be much easier to keep problems in the dark.
- Raise whatever questions with one’s doc, which also means having the kind of doc who is more than ready to have that kind of discussion. If one isn’t, it’s time to find another.
- Obviously, if one is hospitalized, it is much more difficult to do all of this. But someone else can do it for you.
As above, this is not “being my own doctor.” It is being a pt. who can work collaboratively with the docs I see, who are all terrific.
Dr. Sal Giorgianni
With all due respects to the intellect of all who are on this site:
Don’t you all get it yet? All of these medications have risks associated with thier use. None of these medications have everything known about them. No medication will ever be totally safe. Virtually no medication will be completley understood.
That is why they are prescription medicatons.
With this I shall sign off for a good long while.
Shine
I was a healthy 38 year old before taking 10 days of Levaquin. Now I have joint pain, muscle twitching and pain, tingling and burning sensation of fingers and toes, multiple skin problems etc. etc..list goes on. Seeing different doctors to treat these side effects including a Nuerologist, Rhuematologist, Dermatologist etc. Unable to exercise due to horrible muscle, leg pains, I used to regularly exercise before Levaquin. Economic burden for last 6 months from the treatments too. FDA needs to take a look at this medicine again, just the black box warning isn’t enough.
truthman30
With all due respects to the intellect of all who are on this site:
Don’t you all get it yet? All of these medications have risks associated with thier use. None of these medications have everything known about them. No medication will ever be totally safe. Virtually no medication will be completley understood.
That is why they are prescription medicatons.
With this I shall sign off for a good long while.
Medications having “risks” is one thing, but medications which cause more dangers, problems and damage than the original condition are ridiculous..
Beebo
These fluoroquinolones not only cause damage to tendons, but also cardiac, neurological, neuropsychiatric and damage to the mitochondria, often leading to a life long of debilitation and serious illness. Read up on all symptoms and good advice from http://www.fluoroquinolones.org/
For those who need support and info, tips and advice, http://www.favc.info there is a chatroom where we meet every Thursday night.
There is no cure, and we all have to struggle on as symptoms develop.
Debra Morse
I was given Levaquin in 2002 for pneumonia and after the 3rd dose, I started developing stinging pains in the tendons of my hands as well as the tendons and muscles in my legs and feet. Within two more days after that, I developed unrelenting left-side abdominal pains and GERD so bad that the acid even backed up into my mouth leaving it burning like fire as well as the esophagus. Gradually, over time, my symptoms began to lessen with the abdominal pains and GERD (along with the awful metallic taste in my mouth) going first and finally the tendon/muscle problems. However, even today, 6 years later, I still have residual weakness in the left leg that I never had before Levaquin. It took 2 1/2 years of suffering before I could walk up and down steps or even walk up gentle slopes due to the weakness and pain in my legs. I was a perfectly healthy woman with no more wrong with me than high blood pressure (which was and is well under control with meds) until the week I started the Levaquin and I haven’t been “normal” since that week! I am grateful for the healing I did experience from the hellish effects of Levaquin even if it wasn’t 100%. I’m also grateful that I have now found a doctor who does believe that quinolones CAN cause severe side effects (unlike the fool who prescribed the Levaquin to me) and who has made sure that I will not be given any quins again!
Justice in MI
Hi Sal - I guess your gone, but if you care to respond, I am not sure what you’re responding to - the several pt. stories or the notion that pts (if inclined) might do their best to inform themselves about risks/benefits through whatever appropriate means. I can’t imagine you’d object to the last, exactly because of the reasons you note.
But maybe I’m missing your point.
Nathan
Truthman writes: “Medications having “risks” is one thing, but medications which cause more dangers, problems and damage than the original condition are ridiculous..”
That just isn’t true. The severity of the treated disease CANNOT be correlated with the severity of the side effect. Take cars as an example. Do they save any lives? No. Do they cure a disease? No. Do they have a side effect? YES! A very very severe “side effect” - death in car accident. Yet we accept thier risk. Cars kill thousands upon thousands every year just so we can have the “convenience” of getting places faster. You make these kind of risk-calculations in the privacy of your mind every time you get in a car. Why is it somehow different with medication?
Laurie
Oh, Nathan…once again reaching REALLY far!
Lynne G
I had surgery in 2000 to remove a urinary bladder stone caused by a previous unnecessary and unsuccessful surgery for minor stress incontinence. I was given Cipro for weeks prior to the surgery and after. I was told that the inside of my bladder looked like raw hamburger meat. I continued to get UTIs while the bladder surface was healing. I was given Cipro many times over the next 5 years by 3 different physicians. I was 60 or over at the time. I was told by 2 physicians that I needed to be on Cipro for a year. After 5 months in 2005, I stopped taking the drug since I developed severe ear pain. I experienced about 20 side effects, tendon rupture, neuropathy, sensitivity to noises, balance problems, rashes and itching, sun sensitivity, fatigue, vision problems, to name just a few. I’m still disabled and suffering. What in the world will a black box do? This drug needs to be withdrawn from the market.
Nathan
AA writes “Until doctors change their mentality and recognize that mysterious symptoms can be due to meds, we will deal with the same issues whether the side effect rate is .000001% or 100%.”
That’s a fair point AA, but why is 90% of the critisism in this thread railing against drug manufacturers and the FDA? It’s only recently that patients directly report things to the FDA and drug companies. From what I understand, until 5-10 years ago, all side effect data came strait up from doctor’s offices.
Nathan
Laurie, please explain. I don’t think my car analogy is a far reach at all. We accept risks all the time for things that provide no real lifesaving benifit. The list could include swimming pools, toys, elevators, airplanes, and on and and and on. Why are drugs somehow in a different category?? THEY AREN’T! They are a convenience of modern society. They have risks just like other conveniences of modern society.
jane
Nathan, maybe if you look at it as the cars aren’t causing the accidents you can see how assnine your analogy is. How long do you think cars would stay on the market if everytime you drove one the steering caused you to drive in circles?
truthman30
Thats all very well Nathan….
But usually when there are risks with products , cars, swimming pools etc, people are adequately and honestly warned about them ya know? and when they aren’t then of course they are entitled to compensation or at the very least an honest explanation …
Unfortunately for many people, pharma’s track record hasn’t been so good with that in recent times.. ( Avandia, Vioxx, Paxil, Zyprexa… the list goes on and on…)
People do accept that medications can have risks, side effects and adverse events.. but what cannot and should never be acceptable is suppression of negative data to protect profits and unpublished negative trials only being unsealed with lawsuits…
With so many reports of side effects been suppressed and the public been lied to , how does the industry expect people to take then on trust anymore when that trust had been so tragically eroded?..
ciprovictimalso
About cars, I had a choice on what vehicle to buy. I chose 1 that had a higher safety rating.
Nathan
I agree Truthman. As I hope you are aware, most of us in industry are not supportive of suppression of information.
Jane, that’s funny. Think about the analogy a little more and maybe you’ll get it. Or maybe you won’t…
truthman30
I agree Truthman. As I hope you are aware, most of us in industry are not supportive of suppression of information.
I should hope that this is the case Nathan..
But, from what I have researched it seems that this suppression comes from the very highest levels… So until that is addressed there will continue to be problems..
I am not anti-pharma or anti-drugs, just pro consumer and I think we deserve to have access to all the information, not just selected (and sometimes biased)information chosen by the industry…
Nathan
ciprovictimalso,
You also have a choice of medications. You can choose the one you feel is the most safe based on all existing data. You can also choose not to take it if the risk exceeds that which you are willing to take to treat the health problem you are having. The only difference is that the “data” is a lot more technical than that used to rate cars. So by-in-large, we rely on our doctors to interpret that data for you. But all the data that doctors have is publicly available should you choose to research it.
Perlgrau
I took Levaquin while living out of the country for a suspected bacterial infection. By the last day of treatment, I had burning in my muscles and nerve pain so badly that I could no longer function. My heart rate was extremely elevated (170 bpm) and I had severe anxiety and panic attacks. My arms went completely numb; I began passing out whenever I stood up and had to be immediately sent home. I experienced depersonalization, blurred vision, sensitivity to lights and noise, and became agoraphobic. By month 3, my tendons, muscles and joints were hurting me so badly that I could no longer walk. I developed tendonitis in every major tendon in my body, peripheral neuropathy, blood glucose and distubances, liver damage, and damage to the valve of my heart as well as disorder called Postural Orthostatic Tachycardia Syndrome (POTS- which means that my autonomic nervous system can no longer control my heart rate and my blood pools in my lower extremities) all as a direct result of Levaquin. I am in pain on a constant basis and there is nothing that I can take to ease my suffering because I have developed Multiple Chemical Sensitivity and my liver enzymes are so damaged. It has been an absolute nightmare; I wished for death many times. It is now a year later and I have not been able to continue on with my studies or resume work. I have lost everything that I have worked so hard for and I am only 27-years-old. Levaquin has destroyed me; I used to be healthy and happy and now I am broken.
I am glad that the media and public are now starting to pay attention to the dangers of fluoroquinolones but I am very angry that this had to happen to me, or anyone for that matter. I never once was informed that there were any potential risks with taking this medication. I am in shock that it has not been pulled from the market as the FDA’s numbers on adverse events are very low. The ADR rate is NOT 1 in 100,000. 1 in 1,000 seems to be suspect as well. Check out medications.com and it is evident that there are many, many, many people suffering from this class of medications. I personally know 7 people that have had serious problems with this class of drugs. The pharmaceutical companies knew that this drug was dangerous and they failed to release information because they knew that it would interfere with their profits- that is truly criminal.
ciprovictimalso
Nathan,
My husband wasn’t offered a choice of which medication to take. He had 6 ruptures & none of the doctors knew why. If it had been 1 doctor or even 2 or 3 who were puzzled, perhaps I could have blamed their lack of knowledge on them. It was every single doctor of almost a dozen who had no idea why these ruptures were occurring. I believe the warnings on these medicines are the reason why because they are misleading. The warnings say that rare occurrence of tendinitis & tendon ruptures can occur while or after taking these medicines. How long to you does “after” mean? I’m not trying to be argumentive, nor do I wish you to feel that I am taking something out on you that you didn’t do.
david fuller
I’ve not heard of a shred of evidence that pharma has pushed antibiotics for non-bacterial diseases. Please be so kind as to tell me the color of the sky of the world you live in? You and I both know that what you are stating is NOT true. Most sinus infections are viral in nature. Most common colds are viral in nature. Kidney stones have nothing to do with bacterial infections for the most part, and in only 5% of the patients who have prosatitis have a bacterial infection. But what are these drugs pushed to treat? Sinus infections, upper respiratory infections, kidney stones and of course prostatitis. So where did these doctors get the idea to use these drugs for these disease states?
David writes: “And for the FDA to continue to allow this continue for over forty years now is criminal gross malfeasance.” It’s a good thing that the FDA can’t be sued. They seem to be hated almost as much as the pharma companies. You got that right for I would be done to the courthouse at 9:00 Monday morning joining the queue.
Once again, this is a risk-benefit analysis: The rate of this tendon damage is estimated to be approximately 1 in 10,000 scripts. Wrong again. The rate found in the PUBLISHED papers is found to be anywhere from .5% to 16%. Do all of us a favor here and log unto http://www.fqresearch.org and read these papers would you please before spewing the drug companies propaganda?
A couple of points:
1) This would NEVER be picked up in a clinical trial. One would only observe this after YEARS on the market. Strike three and you are out. One study in particular had three such ruptures.
2) Given such a low rate, a given doctor would probably only observe 1 or 2 cases of this side effect durring his/her entire career. They would be unlikely to make the correlation on their own. Ball One. I’ll give you this one, but not for the reasons you stated. Doctors RARELY if ever make such a correlation even when it is standing (one on foot) right in front of them. Who would think that taking an antibiotic would blow out a tendon? Not me.
Truthman writes: “Medications having “risks” is one thing, but medications which cause more dangers, problems and damage than the original condition are ridiculous..”
That just isn’t true. The severity of the treated disease CANNOT be correlated with the severity of the side effect. Then what in God’s name are we even bothering to do a risk/benefit discussion in the first place if not for THAT reason?
Take cars as an example. Do they save any lives? No. Do they cure a disease? No. Do they have a side effect? YES! A very very severe “side effect” - death in car accident. Yet we accept thier risk. Cars kill thousands upon thousands every year just so we can have the “convenience” of getting places faster. You make these kind of risk-calculations in the privacy of your mind every time you get in a car. Why is it somehow different with medication?
Because the doctor is RESPONSIBLE for treating the patient properly. He is the chauffeur if you will. We TRUST that the car we are getting into does not have any obvious safety issues and in danger of spinning out of control no matter what the driver does. Everybody who has a driver’s license knows these risk and accept them as part and parcel of having the privilege to drive. Those who take these drugs have NO such specific knowledge other than of course drugs have risk. But they, and the medical community have been brained washed to believe that such problems abate simply by stopping the meds. It is the moral as well as legal obligation of the drug manufacturers AND the physician to disclose these risk to the patient. Period. No ifs,ands or buts about it. Failure to do so is what is being discussed here. NOT the risk factors, BUT THE TOTAL AND COMPLETE FAILURE TO DISCLOSE THEM.
That’s a fair point AA, but why is 90% of the critisism in this thread railing against drug manufacturers and the FDA? Because they are the ones DIRECTLY responsible for FAILING TO REVEAL THESE RISK. It’s only recently that patients directly report things to the FDA and drug companies. Wrong again. Just not your day is it? These reactions have been reported since 1962, beginning with Nalidixic Acid upon which the pharmcore of these drugs are based. The have been reported BY THE PATIENTS, in regards to this class, to the FDA since 1982. From what I understand, until 5-10 years ago, all side effect data came strait up from doctor’s offices. Nope. You are incorrect yet again. As I stated this has been reported to the FDA by the patients since 1982. Twenty-six years is not 5-10.
If I were to provide all the citations that proves each and every point I made this server would crash. If you wish to read such documentation for yourself then just log unto the research site and read the 4000 medical journal articles, case reports, clinical trials, etc., rather than the drug reps detail sheets.
The whole discussion here is about failure to warn. But you and a few others keep trying to put a different spin on this. Spin Doctors we have enough of. Doctors and drug reps with common sense is what is lacking here.
HorusCat
When I was with Pfizer, we knew the quinilones were evil and dangerous…Z-Pak all the way. Having said that, Cipro worked the last time I had a UTI (Bactrim gives me hallucinations).
BTW, I just peeked into read about the helicopter kerfluffle (my old colleagues say they are getting charged more for personal use of vehicles now–and NO SNACKS at company meetings!)…didn’t know all this stuff about the quinilones. We always go with amoxicillin chez Cat.
HorusCat
Amox for the kids, that is. Last time I took an a-b was 2 years ago for that UTI…(so what else works for cystitis?)
Justice in MI
Hey, Cat. Hope all is well with you. Getting the lipids/TGs checked tomorrow, so I can’t sip a glass my own drug of choice, a good Italian red.
HorusCat
JIM,
Thanks. All is very well. I wish warm weather could last the entire year except for one week of December…of course, that would mean we lived in San Diego, and we can’t afford it.
Hope all your lipids are in order. Get your homocysteine checked while you’re at it (folbic acid lowers it if necessary) and take 1,000 units of Vitamin D, just to be safe.
My husband is happy about the new pharma guidelines, since I keep all my stuff in the garage, and now the box-arrival rate will diminish. On the flip side, my autistic one loves to take the pens apart to use in inventions (I have to hide them), so his creativity will have to follow a new course.
Cheers. I am happy because I was browsing the net and found the proper pronunciation of “whinging.” You could say I’m right chuffed about it!
Laurie
“The whole discussion here is about failure to warn.”
That is the bottom line!
Bob Freeman