J&J And Sandoz Recall Fentanyl Patches
14 CommentsBy Ed Silverman // February 12th, 2008 // 1:01 pm
Why? Manufacturing defects may cause leaks that can lead to fatal overdoses. The Duragesic patches, made by J&J’s Alza unit., may have a cut along the drug reservoir, exposing users directly to the fentanyl gel inside, according to a statement. This is the third recall of some version of the patches since 2004, Bloomberg News reminds us.
“This substantiates the claims we’ve been making for the last four years. They should just stop marketing them. Originally, it was marketed originally for cancer pain, but they’re being used more and more for moderate to severe chronic pain,” says Ike Gulas, a lawyer who represents families of former patch users who died of fentanyl overdose. Juries have found that defective patches caused the deaths of two people since lawsuits over the products began going to trial in 2006, Bloomberg notes.
The latest recall covers patches in the US and Canada that release 25 micrograms of fentanyl in an hour, according to J&J. The expiration dates are on or before December 2009. Duragesic patches generated $1.16 billion in global sales last year, by the way. Fentanyl is mostly used to treat cancer pain, according to the FDA.
The FDA, you may recall, issued a safety warning in December over the patches, saying improper use can cause breathing difficulties and death. That followed a July 2005 alert put out by the FDA after 120 patients taking the drug died.
louis l mitchell
I have been using Sandoz - two 100mg patches - every 72 hours for seeral years. Is there a way to identify particular lot numbers or any identifying criteria for those recalled? Thank you. Lou Mitchell
Jack2
According to the WSJ:
The recall includes all 25-microgram-per-hour patches that are sold in the U.S. by J&J’s PriCara unit and Sandoz; they are made by another J&J unit, Alza Corp.
…and…
“We’re acting responsibly by recalling the defective lot,” says the PriCara spokesman, Mr. Panico, adding that the company can’t comment on pending lawsuits. “Despite the defect, there’s much unaffected product on the market and we think overall the patients have been served by this therapeutic option.”
Sandra Vancheri
About 2-3 months ago I stopped taking Fentanyl Patches. When I started using them the strength was 50MCG/HR. I was on those for back surgery & chronic pain. Then about 2 years ago I was switched to 25MCG/HR. The main reason I got off those was the price, & the medicine didn’t work. I do have an unopened box of 25MCG. I didn’t know iff I should return them to Pharmacy, or throw out. The lot number on thew box is 6S00073 With expiration date of June 2009. This is the Generic form. Please advise. Sincerely, Sandra Vancheri E_Mail: Vwoodcarver70@aol.com
Dr. Charles Coram
My 36 year old sister died on November of 2005 from Fentanyl toxicity. A 100mcg patch was placed on her in the recover room after a “tummy-tuck.” She died 20 hours later. I discover later that the FDA warned doctors in July of 2005 (not to give for one day surgeries), but my sister doctor ignored or was not aware of the warning 5 months prior. Her blood level was 25 times the theraputic level in two hours of activation of the med. (Looks like a leaking patch). The medical board recently found no grounds to punish the physician.
Three FDA warnings, two recalls and people continue to die, what is it going to take!
Jimison
I’ve used Fentanyl patches for several months now for chronic pain associated with lumbar disc herniation and spinal nerve root compression. While there are times of lost lucidity and stupor, this drug has been a life-saver. I couldn’t imagine living without this medication. It’s the only thing that’s worked during the last year.
James Jents
I have worn the 75 hr. 25 mg. fentanyl patch for three years. It has improved the quality of my life greatly, with no problems. After a failed back surgery.
Jere
I am on the 50mcg/hr duragesic and pharmacy that my pain management center uses stocks the Alza generic gel patch and Alza has recalled ALL of their patches! I am forced to use the Mylan Labs patch that doesn’t work nearly as well or pay $200 for brand medication. Only 2 out of 1,000,000 patches are even affected! I am so panicked! This medication has saved my life and b/c of people not using them properly, I am suffering. Doctors are not supposed to prescribe these for “Postoperative use” it states right on the outside of the patch and when you put your patch on you have to hold it to your skin for 30-60 seconds, are you telling me you can’t tell if its leaking!?!
Layla
I am here to say these patches have given me my life BACK. My chronic pain has been helped the last 6 six years on 75mcg. I personally have had no bad side effects from any of them leaking. I am concerned however about the recall because I would still like to be able to get my patches which my body is dependant on,and will go into full withdrawls if I can not get them. Please Please do not punish the people who wear them right and do not abuse them. Please let me know how to identify the ones that leak. And then how do I explain to my doctor there is a recall and I need more or a different prescription? Because doctors only write for certain amount every month and are not going to undstand or care if somone needs a different script before it is time for one. Is it my fault I am dependant on these patches? No like I said before they are helping me a lot. But now the status quoe is you can’t mhave those anymore what am I gonna do? Who will listen? My Doctor the company, the pharmacy, most likley I am SOL. This is not fair!!! Help.
Melody
My mother died on Feb 28th, five days after signing her up with a hospice service, who I believe wrongly prescribed 50mcg fentanyl patches for her.
She’d been suffering from emphysema for about 8 years, and it is clearly stated that this medication affects the respiratory tract (hospice at no time informed us of the reports regarding risks involved - of this one, or any other).
She had not been in extreme pain from her pancreatic cancer yet, necessitating hardcore opiates to keep her comfortable. She therefore did not have the tolerance from the build-up in her system for this now 80 times stronger narcotic (let alone for a beginning dose of 50mcg, which is what she was immd put on by the hospice nurse). This has also been clearly publicized as the prerequisite condition for patients before they are even put on fentanyl.
It has also been published now, that the skin of the elderly does not absorb this medication as it was shown to do in FDA tests of how it SHOULD function and be used.
Yes, my mother would have died from her pancreatic cancer. But not within a matter of days. She still could have had weeks if not months, of some quality of life, until her pain did develop to a stage that this level of narcotic would have been helpful. She would have then gladly agreed to euthanasia, had someone asked her.
I am convinced now after days of reading online reports, and speaking to acquaintances who have had the same experience, that the use of this narcotic by hospice facilities is completely out of control. Someone needs to do something.
Paula
I have been on Fentanyl patches since October, 2007. I also use percocett in conjunction with the patches. My questions is: my liver is now twice its’ size and I am in excruciation pain. They are trying to discern why my liver is so large, i.e. is there any connection to the fenatnyl patch. Has anybody heard of anything like this, from the use of the Fentanyl patches? Thank you.
Mark
I used the 100mg patch and let it BE KNOWN AND FOR WARNING ON A HOT DAY IN AUG. OF 2006… I DIED FOR OVER 7 MINS. DUE TO A BLOOD-CLOT THAT WAS CAUSED by the patch I consider myself a very lucky Man to be alive today.
My Dr. took me off the Patch and said that if the blood-clot had made it thru my heart to my lungs I wouldn’t be here today…
HUGE…Profits… over Health-Care “GREED” by the Meds and these Greedy Companies that are suppose to help us not to Kill us…it all comes down to the $$$ !
Colleen
I was prescribed the fentanyl patch for chronic back pain and for the first 30 days it worked wonderfully, I had thought that I finally got my life back….. I got the first refill, applied the patch, the next morning when I woke up I looked in the mirror and my face was unrecognizable. Parts of my face were swollen to twice their normal size, it took over a month for the majority of the swelling to go down. This happened in August of 2007 and one of my cheek bones is still noticably larger than the other.
I hate to think of what it might have done internally!! I have been hospitalized twice since this happened and didn’t even consider that it could have been the result of the defective patches. I followed my doctor’s instructions and in no way abused the patches. (Included that since a couple of people that posted are blaming the recall on people who abused the patches instead of blaming the manufacturers)
TJ
My 21 year old son died after being prescribed fentanyl 50mcg while on 2 other prescribed RX’s that already suppressed the respiratory. He had problems with the sandoz fentanyl patch adhering properly. He had the patch on for approx. 28-30 hours. He had slept 17 hours straight of those total hours. He woke up drenched in sweat and called me to explain his severe shoulder pain and ill feeling. He showered and went back to bed for less than an hour. He was found dead a couple of hours later. Since my son’s death in 2007, I have met numerous other people in my community who have lost loved ones due to fentanyl. He will never know his baby girl who was born 6 months later. What is it going to take, till the Manufacturers and MD’s wake up. How many others must die, until stricter prescription guidelines are imposed. Before these patches were to be used for other purposes, the FDA should have tested them with a variety of other drug classes. MD’s should heed more caution and be more responsible to their patients.
Margie DesPlaines
I have been on the 100 duragesic patches 2 patches every other day for several years!!
I had no life before the patch..They have given me my life back!! I am sooo upset about this news..what in the world can we do??
I have never had a side effect in anyway!! I use them as perscribed by my physician and I always check to make sure there is no hole in them or that the back is sealed all the way around! I have never had a problem but if all people that use the patch would follow the directions and make sure the patch isn’t damaged in any way..there wouldn’t be all the problems people have reported!! Its not the manufacturers fault if people don’t educate themselves when they are perscribed a new medication!! The pharmacist also offers to educate you when you pick up your medicine! It seems to me the manufacturer should not be held accountable if people arn’t going to read the precautions and follow the complete instructions! So, now the manufacturer and the patients have to suffer because customers are not reading instructions and wearing the patch properly!!! Before I was put on the patch I had no life at all and this was 8 years ago. I have been on the 100″s 2 every other day without having to increase the stregth for at least 6 years now!! My physician said to me at my last appointment that I am the exact reason why they make this medication…to give back the quality of life that an accident or some other misfortune has taken from us!!
I personally would rather die than spend each and every day in pain suffering & causing everyone else that cares about us to suffer right along with us!! Can’t the manufactures have people sign something that protects them against law suites that people cause themselves?? Any suggestions from anyone at all I would really appreciate any help at all!!
God Bless!
Margie DesPlaines
margedesplaines@hotmail.com