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FDA Pulls 500 Cold Medicines From the Market

Agency Says Many of the Drugs May Have Unapproved Ingredients or Inappropriate Labels

Kids Under Age 2 continued...

“I fully support the FDA’s move in controlling access to these medications in children; it is highly appropriate and long overdue,” she says.

As to the risks these drugs pose, “for the most part, [these adverse reactions] are not serious,” says Charles E. Lee, MD, medical officer of the division of new drugs and labeling compliance at the CDER.

After the FDA crackdown on the use of over-the-counter cough and cold medicine in children younger than 2, the number of emergency room visits for adverse events decreased by 50%, he says.

“We also know that 15% of these events came from prescription cough, cold, and allergy products and included sedation/drowsiness and irritability,” Lee says.

Ingredients in Prescriptions

When asked whether the use of these prescription medicines has increased since the over-the-counter restrictions, Michael Levy, director of the division of new drugs and labeling compliance at the CDER, says, “I don’t think we can say we have seen an uptick, but certainly we were concerned that the same types of ingredients were still being used in unapproved prescription products.”

“These are well-recognized drugs that have been used for decades and there is no reason to suspect that there is a risk involved,” says Harold Nelson, MD, an allergist at National Jewish Health in Denver. “If there were risks such as hypertension or stroke with oral decongestants, it would be more appropriately addressed by eliminating the ingredient from all products whether those that are grandfathered in, available OTC, or FDA-approved.”

These drugs haven’t cleared certain safety hurdles yet, but that doesn’t mean they are unsafe, he says.

A full list of the drugs involved in the new FDA action can be found on the FDA web site.

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