Well it was an awkward day for the infant cold medicine-hoarding MBA's in the house, let me tell you. The FDA's joint advisory commitees for non-prescription drugs and pediatric medicine met today to review and vote on a petition to ban OTC cold and cough medicines for kids. The result: a near-unanimous vote [21-1] to ban the meds for infants and kids 0-2, and a closer vote [13-9] to ban them up till age 6.
The same drugmakers which pre-emptively withdrew their products from the 0-2 market last week said they'd fight the 3-6 ban recommendation.
The NY Times has a summary article on today's hearing, but it feels pretty thin, fact-wise. I barely looked, but couldn't find any liveblog accounts of the meeting, which was open to the public, but I did find the official FDA paper trail leading up to the meeting, which has a health policy wonk's paradise worth of petition support; research summaries; market data and trends (broken down by age and drug); and additional opinions and data from the drugmakers, poison control centers, the American Academy of Pediatrics, and other interested parties. The briefing information alone runs 356 pages.
You know what, reading through it is actually changing my point of view. The opinion letter from the AAP President Dr. Jay Berkelhammer is especially persuasive. It starts on page 325 of the briefing document pdf. I can't find it online, so I've typed in a few of the most unequivocal excerpts below.
Suffice it to say, after reading through maybe a quarter of the briefing data, reviewing several studies showing the ineffectiveness of the ingredients in these medications [which is definitely not the same thing as a lack of data showing effectiveness], and seeing some much larger numbers for potential overdosing and combination drug overlapping, I'm seriously questioning my previous "eh, the meds are alright" stance.
F.D.A. Panel Urges Ban on Medicine for Child Colds [nyt]
Center for Drug Evaluation & Research 2007 Meeting Documents - Non-Prescription Drugs [fda.gov]
Briefing Information: FDA Joint Meeting - NPD & Pediatric Medicine, October 18-19, 2007 [fda.gov]
Just one study referenced in the AAP President's letter:
Paul IM, Yoder KE, Crowell KR, et al. Effect of Dextromethorphan, Diphenhydramine, and Placebo on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents, Pediatrics 2004;114. [pediatrics.aappublications.org]
Previously, i.e., last week: DT: currently hoarding infant drops, overdosing on dosage information
[Below are some key excerpts from the AAP response to FDA-ONP's inquiry about pediatric use of cough & cold medicines. The letter is from the AAP President, Dr. Jay E. Berkelhammer, MD, FAAP, to Dr. Joel Schiffenbauer, MD, Deputy Director of the Division of Non-Prescription Clinical Evaluation at the FDA-CDER-ONP. (got that?) It's dated Sept. 6, 2007, and can be found in its entirety, including references, on pp325-9 of the FDA's briefing document. ] [Begin quote, emphasis added]
...the following commetns are directed toward the qutsions posed in your letter:
1.a. We are interested in the opinion of the AAP on the labeling that would be appropriate for OTC cough and cold drug products for children.Appropriate labeling should reflect the evidence-based benefits of the use of these products in children, the risks associated with their use, and accurate dosing information so that children's health care proiders can make an informed decision as to whether or not to recommend use of these products and counsel parents appropriately should they choose to do so.
1. As for the efficacy of these compounds, the published literature on the benefits of these preparations does not support their use in children at this age. Not only have these products "not been found to be safe or effective in children under six years of age for the treatment of cough and cold," as is stated in the petition, but also, they have (with the exception of pseudoephedrine, for which there are no pediatric data) been found not to be effective in this population at all. This distinction is an important one. This is not a situation in which pediatric data are lacking and we are unable to say one way or the other whether or not these products work in children. Multiple peer-reviewed studies have concluded these medications and combinations are not effective at the currently recommended doses in children. The AAP, American College of Chest Physicians, and Cochrane Collaboration have reached the same conclusion.
As for the risks, these products are generally well tolerated in children when given in accord with labeling. However, there are at least two important situations in which children are placed at greater risk of the serious adverse events described in the petition.
The first of these relates to the frequent misdosing of these preparations. The OTC cough and cold medications and anithistamines were the sixth and tenth most frequent exposures in children under six years of age reported to US poison control centers in 205, accounting for more than 100,000 cases. The 1998 pediatric data from teh American Association of Poison Control Centers (the most recent published set to break out pediatric data on children under six years of age) demonstrate that 15% of the children received an inappropriate dose of these medications and required treatment. COntributing to this problem is the availability of multi-ingredient preparations that could lead to inaccurate dosing as a result of a caregiver misunderstanding the active ingredients when administering m ore than one preparation. For example, a "cough and allergy" preparationmay contain the same ingredient as one labeled as "chest and nasal congestion." This is made even more complex by the variability in titles given by different manufacturers.
The second source of risk is the complete lack of data to support a therapeutic rationale for dosing in the pediatric population. When parents are advised to "consult with a physician" for the appropriate dose of these preparations in their infant or young child, they expect that the physician has access to evidence-based information on which to base a decision, but this information is nonexistent. Furthermore, the need to consult with a physician is inconsistent with the classification of these medications as OTC. The prescription exemption procedure classifies OTC medications as those that are "safe and effective for use in self-medication as directed in proposed labeling." Reuireing parents to consult their physician for a dose in their infant or child represents an unacceptable shift of responsibility for proper dosing from the manufacturer to the physician, who, given the current absense of data to show that these medications even work, has no rational basis for their dosing.
The potential for inaccurate dosing is further exacerbated by the apparent greater sensitivity of children under the age of two years to the potentially fatal effects of some of the more common ingredients in these preparations... [ed: ?!]
In the letter Berkelhammer and the AAP go on to recommend very strongly worded caution labels on the medications, which can be revised as necessary as data comes in. In addition, he criticizes as "common but fraught with danger" the practice of extrapolating efficacy data from adults for kids. As the AAP sees it, the variability and changes taking place in growing kids make this extrapolation process inaccurate and potentially dangerous.
It's worth pointing out that several DT commenters have made these and similar points before, though not with direct citations that I can recall. It's not that I didn't believe you; it's just that, as far as I know, you weren't the president of the AAP.