FDA Considering Revised Rule For Pediatric Cough and Cold Medications

The Food and Drug Administration has announced a public hearing on October 2, 2008, to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use. Many of these nonprescription cough and cold drug products are marketed under the OTC Drug Review, which published a monograph describing the conditions under which certain OTC ingredients are considered to be generally recognized as safe and effective. Recently, some potential safety and efficacy concerns have been raised regarding the pediatric dosing and use of certain active ingredients in OTC cough and cold drug products. FDA is developing a proposed rule to revise the pediatric labeling guidance contained in the Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. At this public hearing, FDA is interested in obtaining public comment about certain scientific, regulatory, and product use issues as it proceeds with the rule-making and reviews new drug applications (NDAs) for these ingredients.

MassTortDefense notes that there has been significant litigation in the past concerning ingredients used in many over-the-counter and prescription cough and cold medications as a decongestant to relieve stuffy nose or sinus congestion. At one point, Americans took 6 billion doses of the ingredient PPA each year from as many as 400 over-the-counter products containing PPA. A Yale Univ. study suggesting possible increased hemorrhagic stroke risks led manufacturers to remove PPA from their products. This in turn led to a mass tort, MDL and all. The epidemiology of the Yale study, according to plaintiffs, indicated that there were about 10,000 PPA-related strokes in the ten years preceding the FDA withdrawal. As it turned out, of nine PPA verdicts 2000-2006, only one was a plaintiff victory. As a result, PPA defendants were reportedly able to settle hundreds of the plaintiffs' best PPA cases for relatively modest amounts. Multiple PPA cases have been dismissed, either by plaintiffs lawyers or by the MDL court.

Today, FDA estimates that there are approximately 10,000 products being marketed for cold, cough, or combined indications under the OTC Drug Review. Depending on the dosage form and strength of these products, many of them are labeled for pediatric use, including some that are labeled for use in both adults and children. There are approximately 38 active ingredients in the final Monograph. Some combination cough and cold products contain as many as four of these active ingredients in a single dosage form, meaning that patients may be exposed to four different active ingredients when using a single product. From 2002 to 2006, there were approximately 36 billion units of combination cough and cold products sold each year in the United States. For liquid formulations used for the youngest children, there were approximately 190 million units sold each year in the combined cough and cold categories during this period. Cough and cold products are commonly used in children. A recent report suggested that 1 in 10 children uses one or more cough and cold products during a given week with exposure being highest among 2 to 5 year-olds.

FDA is interested in obtaining public comment on several issues, including:
1. What types of studies should be conducted to assess effectiveness and/or safety, and determine appropriate dosing of cough and cold ingredients in the pediatric population?
2. Should cough and cold products for the pediatric population continue to be available OTC, or should they be made available only by prescription?
3. If the pediatric indications and dosing for cough and cold products were no longer available OTC, would the public use the adult formulations of the products for children, and thus create a greater potential risk of misuse or overdose?
4. Current standards permit extrapolation of pediatric efficacy  -- but not safety-- based upon sufficient adult data. Does it remain appropriate to recommend in the cough and cold monograph that children 12 and over should receive the same dose of medication as adults, without requiring any additional studies in children in this age group?