Cold Meds May Be Life-Threatening For Babies
23 CommentsBy Ed Silverman // August 4th, 2008 // 8:36 am
Yet another study raises questions about the dangers of giving cough and cold meds to babies. A “surprising” number of small children taken to emergency rooms after they stop breathing or lose consciousness have OTC meds in their systems, USA Today writes, citing Pediatrics.
About 5 percent of patients under age 2 had the drugs in their urine, Raymond Pitetti, associate director of pediatric emergency medicine at Children’s Hospital of Pittsburgh and the lead author, tells the paper. None of their parents, however, admitted to giving the children medication or taking the cold products themselves, which could cause the drugs to pass into breastmilk.
Pitetti says his study - in which doctors performed toxicology tests on 274 children at the Pittsburgh hospital between 1997 and 2006 - strongly suggests the cold meds caused the life-threatening events, in which the babies turned red or blue, stopped breathing, passed out or went limp. Although Pitetti says he can’t rule out that something else caused these symptoms, he notes that the ingredients in cold meds can make babies stop breathing.
You may recall that, last January, the FDA recommended that OTC cough and cold meds should not be given to children under age 2 because of the risk of “life-threatening side effects.”
The American Academy of Pediatrics cautions that cough and cold meds may pose serious risks in these children, including death, convulsions, rapid heart rates and reduced levels of consciousness,USA Today reminds us. And drugmakers have voluntarily withdrawn cough and cold meds for children under age 2.
In October, an advisory panel to the FDA noted the meds aren’t effective in children under age 6 and shouldn’t be given to those children.
About 7,000 children under age 11 — including 1,500 under age 2 — go to hospital emergency rooms each year after taking cold and cough medicines, USA Today writes, citing data from the Centers for Disease Control and Prevention. About two-thirds of these children took the meds without a parent or caregiver nearby. A recent CDC study found that cold and cough meds caused the deaths of three babies under age 6 months, found dead in their homes, in 2005, USA Today continues.
Salmon
I believe I know the mechanism, and it’s not good news for industry.
Due to the ‘Pediatric Rule’ requiring development of drugs in children, (think psych drugs)drug interactions are going to make it even worse in the future.
Better to get rid of those OTCs (we only sell $40 million /year) and save the market on our multibillion blockbusters.
Salmon
Lisa Van S
But Yet,… AAP supports prescribing antidepressants and antipsychotics for children under six,..No Parental Consent needed. “Multibillion Bluckbusters”, AAP will no doubt benefit!!!
M Helm, MD
Lisa,
Your assertion is untrue. The AAP and the AACAP (child and adolescent psychiatrists) do not advocate anything like what you describe. These societies have developed specific screening, diagnosis, monitoring and treatment guidelines for depression, anxiety and ADHD and a number of other conditions. These are the standard of care advocated by the professional societies most concerned with children.
These guidelines/practice parameters are publicly avaialable to the best of my knowledge. If you have difficulty accessing them at home, any medical library could certainly help you find them. I would also suggest that you look at http://www.parentsmedguide.com and http://www.physiciansmedguide.com for information written by the Am. Psychiatric Assn. and the AACAP to see the official position on antidepressants in children. Though you should recognize that many if not most children’s mental health providers recognize the value of behvioral therapy and other counseling interventions with young patients and/or their families.
The AAP’s position on cough-cold medications, and generally other medications without proven safety and effectiveness, is that they should be avoided. Here is a link to an AAP web-page with advice on cough-cold treatments: http://www.aap.org/publiced/BR_Medicine_OTC.htm
A concise statement of the AAP position (also taken from an AAP web page) is below:
“Withdrawal of Cold Medicines: Addressing Parent Concerns
——————————————————————————–
2008
American Academy of Pediatrics
——————————————————————————–
In January 2008, the Food and Drug Administration (FDA) issued a public health advisory stating that children younger than 2 years should not be given cold medications because of serious and life-threatening side effects. The American Academy of Pediatrics (AAP) position is as follows:
Over-the-counter cough and cold medicines do not work for children younger than 6 years and in some cases may pose a health risk.
The efficacy and risk of such medications needs to be studied in children. As the AAP has testified: “If a medicine will be used in children, it should be studied in children. Cough and cold medications should not be exceptions to this rule.”
The labeling needs to reflect what we know—the medications are not effective for children younger than 6 years and their use, and misuse, could cause serious, adverse side effects.”
In this area, I believe, the AAP is taking the lead on protecting the health and safety of young children. This has always been the goal of the AAP. The clinical practice statement by the AAP on Cough-cold medications, consent, and many other issues can be found at: http://aappolicy.aappublications.org/policy_statement/index.dtl
Lisa, I’m truly sorry that you and your family and many others have suffered harm due to indiscriminant/unthinking prescribing of medications. We agree that in many areas there is much to be done to improve the standards of care - in my view, especially to our most vulnerable populations. I perceive significant problems with the ways “mental health” medications are used in children. Through careful study of this problem with the resources available to me, I think a large part of this due to a lack of availability of well-qualified providers of children’s mental health services. There may also be a significant portion which is pure quackery. I can see that a large percentage of “mental health” treatments for children are prescribed by general psychiatrists (or persons with no board certification at all in psychiatry). Another significant percentage of “therapy starts” occur when children are admitted to psychiatric facilities. In the data I can see, more children are started on the “mental health” medications by nurse practitioners than by pediatricians.
Appropriate critique is always welcome, and fair game. There is plenty of fault to find with the FDA, PhRMA, the provider community, and even with consumers. There are also good an commendible things to say about all of these groups as well. I value you as a consumer advocate, and wish you well with your endeavors to the extent that they improve patient care. However, please keep Pharmalot slander-free.
Lisa Van S
First of all parentsmedguide.org was not established by the FDA,.. but instead by individual groups who have rcved millions of dollars from the pharmaceutical industry to push their agenda,.. “Profits”. FDA shot down Dr. Fasslers testimony in regards to this guide on June 13 2007. I know because I sat next to Dr. Fassler and debated the issue before the FDA officials.
Parents should never, ever, rely on parentsmedguide.org for unbiased information.
Secondly,… AAP must take responsibility for what their Lobbyists say publicly. Maybe AAP should stop accepting Pharma contributions.
Lisa Van S
H Helm MD,
NJ Child and Adolescent psychiatrists oppose Informed Consent. Letter to NJ State Assemblyman Patrick Diegnan
http://www.pharmalot.com/2007/06/in-nj-a-fight-over-black-box-warnings/
Laurie
Mhelm…the “http://www.parentsmedguide.com ” came out almost immediately after the official FDA approved Med Guide. Instead of just providing the FDA Med Guide, these organizations chose to create their own. While some of the information is the same, the overall tone of this guide is that the drug is safe and effective for children and teens…which is not the fact with ssri’s.
“A “black box warning” is a form of label placed on some medications. The FDA uses it to alert prescribing doctors and patients that special care should be exercised in certain uses of a medication; for example, for patients with particular medical conditions, or patients within a certain age range. ”
The above statement hardly portrays the serious nature of a black box warning.
The guide skims over off label use, it makes no reference to the fact that ssri’s, with the exception of Prozac, show no efficacy in clinical trial and the manufacturers of those drugs have been public on their drugs NOT being prescribed for children.
“These societies have developed specific screening, diagnosis, monitoring and treatment guidelines for depression, anxiety and ADHD and a number of other conditions. These are the standard of care advocated by the professional societies most concerned with children. ”
Just because treatment approaches are made a “standard of care” doesn’t mean they are effective and safe. I think that Tmap proved that.
I would have loved to see these organizations encourage therapy and counseling for children as the first line of treatment, instead of touting medication and therapy as the gold standard.Also missing is the possibility of withdrawal(discontinuation) from these drugs. I can tell you that this aspect of ssri use is rarely explained to parents.
The one section of that “guide” that disturbs me the most is:
“but once a child or adolescent has one period of depression, he or she is more likely to get depressed again at some point in the future. Without treatment, the consequences of depression can be extremely serious.”
This leads parents to believe that every level of depression requires “treatment” and that not treating dooms your child to lifelong problems, which is far from the truth.
Parents want full disclosure..the good the bad and the ugly, before making a medication decision for their children. We don’t want it sugar coated or minimized, we don’t want it presented as “you must treat this condition or you are a bad parent and doom your child to a life of depression”. We want ALL of the alternatives presented equally and honestly. But most of all we want all the risks and downsides made clear based on the best science we have today. In this internet age a parent can google for a drug and talk to hundreds of thousands of users of a particular drug. When they discover information that is not addressed or even mentioned by their physician from those users, the trust level with that physician is gone.
It’s time for physicians(all specialties) to provide ALL of the information about a drug without minimizing or hyping any one aspect of that drug.
Physicians have no problem immediately responding to a warning for cold medications for the under 6 age group, but that same warming for ssri’s get rationalized away. Somethings wrong there.
M Helm, MD
Laurie and Lisa Van S,
Our areas of agreement are in fact more numerouse than our areas of disagreement. Lisa made some statements which were untrue, and unrelated to the concerns regarding the safety of cough cold medications. Her statements were colored by her own biases. I’ve got my own bias, as do we all, but the issue here is not specifically related to your particular cause.
My concern is how often or infrequently, treatment guidelines are 1) known and understood by the provider community and 2) actually followed. The AAP has long had a policy statement expressing the positions listed above in relation to cough cold medications. Still they are prescribed and recommended. The article (and this wasn’t the only one in the issue relating to cough cold remedies) was published in Pediatrics - the journal of the AAP.
AAP did not produce Parentsmedguide, and I’m familiar with the timing. The third paragraph of the guide says: “Fortunately, when depression is recognized and correctly diagnosed, it can be treated successfully. A comprehensive program of care should be tailored to the needs of each child and his or her family. Treatment may include
psychotherapy or a combination of psychotherapy and medication. It may also include family therapy or work with the child’s school as well as interacting with peer support and self-help groups.” My reading of the guide is different than yours.
I’ll make only two more comments:
TMAP was not an evidence-based approach, and is an affront to good treatment practices.
Intervention in depression in young people is linked to improved outcomes in children and adolescents - this is typically with the behavioral interventions, but not yet proven with the medications. I’m not sure of the strength of that evidence, but even the American Psychological Association agrees with that. The APsyA are not medications advocates, but understand their utility.
There are clear risks of minimizing treatment for young patients with depression and other serious mental health conditions. If medication is the only treatment offered, parents and patients should seek other providers.
I absolutely agree that parents need and deserve full disclosure of treatment options and risks/benefits as best we understand them. We also need more information on what exactly are the risks and benefits. I’m an advocate for full disclosure of off-label/experimental uses. I can’t understand why you can’t find more folks who advocate for that - could it be that your are in the heart of the nations’ medicine chest? Back on topic, the more we know about the cough cold products, the more signal becomes apparent their use should be limited.
Salmon
I was doing a little background searching on this and found something really, really interesting.
I’m not going to say anything now but I know some people who are going to be really interested in this information.
Salmon
Lisa Van S
H Helm MD
I attended the FDA hearing in February of 2004, ,..Where were you?
I was questioned by Congressional Investigators,.. Where were you?
I attended both Congressional Hearings in September 2004,.. Where were you?
I attended the FDA Hearing in September 2004,.. Where were you?
I participated in the FDA Medication Guide Hearings,.. Where were you?
And when I was sitting on a floor in my Attorney’s office, sifting through Pharmaceutical documents,… Where were you?
And when a Raritan Twsp police officer cradled my daughter’s bloodied body,.. Where were you?
You weren’t there, you base your opinion on what has been spoon fed to you,.. and that opinion is dangerous to our children.
Yes,.. NJ is the Medicine Chest. Not sure what that has to do with the price of tea in China.
Laurie
“Treatment may include
psychotherapy or a combination of psychotherapy and medication. It may also include family therapy or work with the child’s school as well as interacting with peer support and self-help groups.” My reading of the guide is different than yours.”
If I was seeing this in practice I could agree completely. But is not happening in the real world.
This is what is being told to parents(these are direct quotes from parents)
“Teens don’t do well in therapy, don’t waste your time”
“Your child has a chemical imbalance..no amount of therapy is going to help that”
“This is all hormonal and this drug will get them over the rough spots. Take it for a year and then you can stop it”.
“You child seems very angry and aggresive…we should increase the dose since he’s gained alot of weight he’ll need more paxil”.
“Don’t read the internet about this drug..the internet is all lies. These drugs are completely safe and effective”.
I’m sure you can understand the frustration when I hear physician comments such as this.
I think we do agree on alot of points. But when those AAP recommendations are rarely seen in a medical practice one has to wonder how effectively they are being made clear to physicians.
M Helm, MD
Lisa,
I’m really not sure what you are saying, and why you are making an ‘ad hominem’ attack.
Do you mean that because I was not with you, I am against you? You don’t know anything about my personal experiences or education and training, or in fact the basis of my opinions. You are correct that my experiences are not identical to yours. But your arguements and general tone seems to indicate that my opinions are at a minimum invalid, and poorly informed, and at worst: “dangerous to our children.”
I’m not sure what to take from your comments, but they do not seem to be building the possibility of dialogue or mutual enlightenment.
The irony is that I am supportive of change in the standards for mental health care in children and adolescents. The strident, absolutist, and dismissive tone of your posts, and your reliance on unsupported generalization and hyperbole (more reflecting your preconceptions than anything I’ve posted) may not be helping your cause.
My grandmother always used to say: “you catch more flies with honey than vinegar.” Of course she also used to say: “my advice is free, and it is worth what you paid for it.”
M Helm, MD
Laurie,
The quotes you share are appalling. I also know them to be true, because I have heard them at the source. Peer-to-Peer education is helpful, and I’m not above correcting false information whenever I encounter it. There’s a lot to be said for educated consumers too.
Any parent who hears anything like the quotes you cite should run, not walk, to a competent provider. Most probably this would be someone who can not prescribe medications more easily than provide other services, almost certainly that means someone with experience treating children - the waiting room and board certification tell a lot in this instance, but certainly not the whole story.
The only statement with a grain of truth is the comment about the internet. There are obviously differences in the quality of information available, and some must be approached with caution. I typically recommend .gov and .edu sites or specific .org sites.
At a minimum, there is a gap between practice and guidelines. That’s a quality problem, and it is serious. It applies to mental health treatments in children and to the use of cough-cold medicines.
Lisa Van S
H Helm MD,
“The strident, absolutist, and dismissive tone of your posts, and your reliance on unsupported generalization and hyperbole etc,..etc.” WOW!!, This description fits Peter Pitts of DrugWonks, beautifully, and one could assume Industry taught me well!!!
Poorly informed,.. yes, I believe you are. And, like you, I am entitled to my opinion.
You would serve your pediatric patients well by providing them with unbiased information, and not information provided by Special Interest Groups who rely on Industry funding.
My Grandmother made those type of statements also, and, if she were alive today, she’d say, you go girl..
Laurie
“There are obviously differences in the quality of information available, and some must be approached with caution. I typically recommend .gov and .edu sites or specific .org sites.”
LOL! This is why my site is a .org.
M Helm, MD
Laurie,
Scientology also has a .org site, so as I said, I recommend specific .org sites. I’m curious about yours. Can you post a link?
Lisa Van S
Laurie,
Maybe the good Dr. would like to answer patients “victims” questions, as a guest, and Maybe provide some medical advice.
Lisa Van S
Laurie’s Website is
http://www.paxilprogress.org
I also like this one
http://www.paxilharmschildren.com
Jane
When I go looking for information I start with blogs such as this one. I rely heavily on what patients are saying and less to what docs and the government are saying. I have found the dot gov and dot ed sites have all the same information as the pharma sites. The blogs, such as this one, have more real life information. If enough people are saying the same things about the same medications that carries a lot of weight with me. Good blogs tend to have good links.
What good is going to the gov and ed sites if they are just repeating what Pharma wants us to believe. As Laurie pointed out with the quotes wherever the docs are getting their information, isn’t working.
Laurie
Ah, Helm….that was a low blow! I’m as WASP as they come, registered nurse of 25 years experience and yes, my site is http://www.paxilprogress.org. A site created by an early paxil user to help other users of ssri’s get off these drugs safely. I took it over 3 years ago after successfully getting my son off Paxil.
I would love for you to visit…you won’t find any scientology claims on it. Just real world people dealing with the long term effects of a specific group of drugs. It’s quite eye opening, and you may just learn something!
Lisa Van S
Laurie,
His true colors,.. come shining through. It was just a matter of time!
Never trust a poster he chooses not to identify themselves.
Lisa Van S
H Helm MD
You will never earn the respect of consumers by playing the Scientology card, Its a Pharma ploy that is getting quite old!
John Travolta can park his spaceship in my backyard anyday!!!
M Helm, MD
Laurie, I’m sorry if I offended, that was not my intent. What I meant was that not all .org sites are going to present useful/helpful/accurate information. I was not equating your site to the Scientology site.
At this point I haven’t seen your site. I was and am genuinely curious, and I will check it out. Thanks for posting it.
As for discontinuation of antidepressants - that is a thorny issue. Worse for some than others, and I haven’t seen much research on it. Of course most of the research into these medications is for relatively short-term use of a few months. After that, there is little to no guidance on what is safe to do next. Clever marketing strategy isn’t it?
Certainly it is easier to wean (or titrate up) counseling. I’m sorry that your son had to deal with paroxetine - not a drug I liked even prior to the black box.
Laurie
No offense taken….I’m used to it. As most realize, if I was a Scientologist my son would have never been on Paxil.
Discontinuation is a thorny issue. Widely ignored or misdiagnosed. I hope you will look at the site. It’s a very varied group from all over the world. As we often way, todays users are the long term clinical trial but no one is collecting the data.