HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Wednesday, October 17, 2007

FDA Hearing on Toddler Cold Medicines

As  you are probably well aware, last week several manufacturers of cold medicines for toddlers recalled their products from the market.  This Thursday, the FDA will hold hearings on the safety of these cold medicines.

On Thursday, the Food and Drug Administration will meet to discuss whether over-the-counter cold medicines are safe and effective in children age 6 and under. Earlier this year, the FDA completed a review that found between 1969 and the fall of 2006 there were 54 reported child deaths from decongestants and 69 from antihistamines. Most of the deaths occurred in children under 2. Baltimore Health Commissioner Dr. Joshua Sharfstein headed the push that led to the FDA hearing. He became alarmed when four Baltimore children died after their parents gave them excessive doses of cold medicines. "I didn't quite realize that it could potentially be a life-and-death issue," says Sharfstein.

In August, federal health officials recommended the "consult your physician" advice to parents on the labels of cold and cough medicines aimed at young children be replaced by a warning not to use the medications in children under 2 unless directed to do so by a health care provider.

   Last week, in advance of the hearings, some of the leading manufacturers of cold and cough medicines announced a voluntary recall of more than a dozen cold medicines for infants. The Consumer Healthcare Products Association said the products were being pulled "out of an abundance of caution."

Potential misuse of the medications, not product safety, is driving the voluntary withdrawal, the group said.  In a written statement, the group's president, Linda Suydam said, "It is important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately."  The recall "in no way affects our taking this issue to the advisory committee meeting," said Dr. Joel Schiffenbauer, deputy director for the FDA's Division of Nonprescription Clinical Evaluation, Office of Nonprescription Products, Center for Drug Evaluation and Research. "All potential actions are on the table," he said.

I wonder if some parents will hoard this drugs and continue to use them anyway - as a close friend has predicted.  I am not so sure that I agree about the potential for hoarding but I admit when the doctor informs me that my son, who is coughing and snuffling and quite unhappy, has a virus and all he needs is some TLC, I feel like asking for drugs for myself.

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