FDA Cracking Down on Unapproved Prescription Drugs

Agency to remove unapproved cough, cold, and allergy medications from U.S. market

WEDNESDAY, March 2 (HealthDay News) -- The U.S. Food and Drug Administration intends to remove select unapproved prescription cough, cold, and allergy medications from the U.S. market, the agency has announced.

The unapproved drugs have not been evaluated by the FDA for safety, efficacy, and quality. Health care providers may unwittingly prescribe unapproved drugs because the drugs' labels do not reflect their unapproved status.

Consumers are advised to contact their health care provider to discuss alternatives if they suspect they are taking non-approved prescription cough, cold, and allergy medications, and both patients and providers are encouraged to report adverse events or other problems related to the products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

"Removing these unapproved products from the market will reduce potential risks to consumers," Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in a statement. "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."

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