New Standards For Kids’ OTC Cold & Cough Meds
5 CommentsBy Ed Silverman // August 25th, 2008 // 7:47 am
The move by the FDA comes in response to rising concerns that the products are ineffective and could be unsafe, The Washington Post reports. And so the agency said that, for the first time in decades, it will revamp the criteria that have allowed the products to remain on drugstore shelves.
“Modern science has advanced since, and this is an opportunity to apply modern science to evaluate these products,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, tells the paper. The FDA issued a public health advisory last January.
As the first step in that process, the agency will hold a special hearing Oct. 2 to begin to consider a series of questions, such as: What types of studies should be done to evaluate the products? Should the products remain available without a prescription? How should the doses be determined? Should products that combine different ingredients remain available?
The announcement is the latest response to a petition filed in March 2007 by a group of pediatricians asking the FDA to restrict the use of the products, citing a lack of evidence that they work and mounting evidence that they can cause hallucinations, seizures, trouble breathing, heart problems and other complications, including occasionally deaths, the Post writes.
elliottg
I think this is stupid. What are these pediatricians trying to accomplish by removing these products? (I suspect more office visits which means more prescriptions for antibiotics which means more resistance which they also don’t wish to happen so their petition is self-defeating.) It will take years to get them off the shelves entirely and there seems to be little indication that they cause problems (as opposed to being ineffective). As far as I can tell the vast majority of problems are caused by these medicines being used incorrectly (even the > 2 year old products where the ban had a more reasonable basis). If we are going to ban things then let’s go ahead and make it illegal to conduct regular physicals for adults since studies show there is no benefit.
Salmon
If you look at the autism blogs, it appears that many of these lethal reactions are occurring in children who are taking atypical antipsychotics.
Many of these antipsychotics have similar serious AEs and have warnings not to co-administer with drugs MAOIs due to these serious toxicities. Not that these cough and cold medications are MAOIs however many (e.g. pseudoephedrine) are also metabolized by MAO and many are also metabolized by CYP2D6, (e.g. dextromethorphan and antihistamines).
Consequently, the problem may not be the pediatric cough and cold meds per se but the severe reactions that may result from antipsychotics that are coadministered and the accumulation of toxic metabolites that can’t be eliminated in when various cough and cold meds are coadministered.
By going after cough and cold meds FDA may be trying to introduce a red herring and eliminate the problem by eliminating the less risky (and less profitable) of the two components required.
N.B. How FDA began going after similar drugs (i.e. dietary ephedra) about a month before issuing the warning about Phen-Fen back in 1997. The toxicity of Phen-Fen is also in part due to a toxic metabolite that coadministration of ephedra would interfere with its’ metabolism and result in the accumulation of the toxic metabolite.
Even though Phen-Fen toxicity takes several months to show up in most individuals. People with underlying cardiac problems can exhibit heart arrhythmias psychosis, and sudden death after a single dose.
Salmon
M Helm, MD
Elliottg,
I think what the folks who started this are trying to accomplish is protect children from unintended harm. OTC cough cold products are confusing to even sophisticated parents. The myriad combinations of ingredients, and claims make it hard for people to understand exactly what they are giving to their children.
There are also problems with dosing. The doses printed on the boxes of acetaminophen, ibuprofen, and diphenhydramine are considerably lower than what pediatricians routinely recommend. However when meds are mixed and matched to address symptoms, overdosages are possible.
Adverse events occur without other medication use, though Salmon is correct that this is yet another complicating factor. The incredible growth of atypical antipsychotic use in children (even preschoolers and toddlers) with essentially no evidence for usefulness or safety is a different kettle of fish.
I’ve seen and treated (in the hospital) babies with complications of oral decongestant use. (Fortunately, I haven’t seen any die as a result, but Pediatrics recently published an article about that.)
As for increasing visits to the office, I’m sure that is not a goal. Some offices give very detailed instructions on when NOT to call or come in for common, self-limited viral infections.
Because of my “real” job, I only see sick kids in the clinic. I discourage use of OTC medications (and Rx Cough Cold products also) by simply asking - “Did it help?” The answer is invariably “not really.” I always teach parents about the wonders of saline nasal washing for congestion, cough and sore throat. Often, if the kid is really congested, I will demonstrate exactly how much snot one can remove from a baby or toddler with 5ml saline. For children over one year with nighttime cough, I address that with the recent study that showed buckwheat honey beats dextromethorphan (the most common OTC cough suppressant) in children, but that even when nothing was done, the kids got better.
I don’t think most parents come to the office with an expectation of an antibiotic anymore. Most are relieved when they are told there aren’t any serious signs and that the child can be expected to be better in a few days - irrespective of anything the parents or I choose to do. No one has ever convinced me to prescribe an antibiotic when it wasn’t warranted.
For a number of years, the American Academy of Pediatrics has pointed out that cough cold meds haven’t been shown safe or effective in kids under 6. I can’t say that all practicing clincians follow the advice of the AAP on this, but there are some recommendations on the public portion of their website: http://www.aap.org/publiced/BR_Infections.htm
There is an AAP policy statement from more than 10 years ago that points out that suppressing cough may be dangerous in certain respiratory conditions. In my opinion, this whole thing has been slow in coming. If any of these work, it would be nice to know. If they don’t work at all, it would be nice to stop spending money on them. If they work, but aren’t sufficiently safe to permit use without a prescription, there should be a change in status from OTC to prescription only.
Changing status would not take long to accomplish, doing the research would.
I won’t comment on annual physicals for adults, but wouldn’t it be great if everything we did in healthcare had good evidence that there is a benefit, that the costs didn’t exceed the return, and that the risks were understood. I know we would spend a lot less of our GDP on health if this were the standard.
elliottg
Thanks for the thoughtful reply. There is just so much that doesn’t have good evidence, but we allow so I’m not sure how we should weigh the harm here. The adverse reactions are due almost entirely to misdosing (and in many cases those doses are self-administered). As a parent, the benefits of benadryl seem seriously underrated by the pediatric community and I was mistakenly under the impression that it was being targetted as well.
Nathan
I agree, Elliottg. There are no clinical trial evidence that these drugs do any good, so pediatricians seem to think that these drugs are ineffective. Parents who use them appropriately know otherwise.
For the most part, these drugs have NOT been shown to be ineffective. Rather, there has simply not been well-controled clinical trials to study their efficacy. Unless the government sponsors the research, there likely will never be well-controled clinical trials to study their efficacy - these drugs have long ago lost patent protection and they generate quite small amounts of profit for the manufacturers.