FDA Removes 500 Unapproved Cough, Cold and Allergy Drugs From Market

The FDA has ordered a massive recall for 500 different types of cold, cough and allergy drugs that were never approved for distribution in the United States. Some of the medications have been on the market for decades, and the federal drug regulators indicate that people may be at a greater risk when using these products than when using approved prescription drugs or over-the-counter (OTC) medications. 

Some of the products targeted by the FDA’s unapproved cold drug recall on Wednesday are prescription drugs and others are available over-the-counter. None of the drugs affected by the action are widely popular or well-known. The FDA says none of them have ever been evaluated for safety, effectiveness and quality.

FDA officials said that in many instances, health care providers are unaware that the drugs are unapproved because they do not have a disclosure on the label. The FDA recommends that health care professionals review the complete list of unapproved cough, cold and allergy drug products and discuss alternatives with any patients they have that are using the medications.

“Removing these unapproved products from the market will reduce potential risks to consumers,” Deborah Autor, director of the FDA’s Center for Drug Evaluation and Research’s Office of Compliance said in a press release. “There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products, available to treat cough, cold, and allergy symptoms; so we expect little or no negative impact on consumers from the removal of these unapproved products.”

Any company whose products are on the list have 90 days to stop manufacturing them and 180 days to stop distributing the drugs.

This latest action is part of an ongoing FDA campaign called the Unapproved Drugs Initiative. Started in June 2006, the initiative is attempting to scour the U.S. marketplace clean of unapproved drugs. Many of the unapproved drugs the FDA has targeted in the past have not listed the fact that they included active ingredients that were under FDA control.

Earlier agency actions have gone after diet pills and painkillers that were either unapproved generic versions of drugs already on the market or which were sold as homeopathic products, claiming to have no FDA-regulated drugs in them.