The FDA announces it will pull 500 unapproved cold and allergy medications from the market

Omaha, NE – The U.S. Food and Drug Administration released an announcement last week that it would be removing 500 unapproved cold, oral cough and allergy medications from the market.

Dr. Tom Casale is a Professor of Medicine and Chief of Allergy and Immunology at Creighton. He says, since 2006, the FDA has been looking at different categories of drugs and trying to rectify the approval and distribution of medications that are not approved. Dr. Casale says the individual components of all these drugs have been approved by the FDA in various formulations but sometimes the drugs were modified slightly, repackaged or combined with several other approved drugs. He says the issue is these new formulations were not specifically studied for safety and efficacy. As far as the impact on patients, Dr. Casale says, "over the next three to six months, these products will be off the market. But all of them are available in approved formulations, so it should not affect patients having access to similar types or the same types of medication manufactured in a way that the FDA approved."

A list of the pulled medications may be accessed online at