FDA Pulls 500 Cold Medicines From the Market
Agency Says Many of the Drugs May Have Unapproved Ingredients or Inappropriate Labels
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.