FDA Orders 500+ Unapproved Cold Medicines off the Market

The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States. Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC). Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval. Consumers who believe they are taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss alternatives. Companies that have previously listed products subject to today’s action with FDA are expected to stop manufacturing them within 90 days and stop shipping the products within 180 days. Companies that have not previously listed products subject to today’s action with FDA are expected to stop manufacturing and shipping their products immediately. Given that so many cough, cold, and allergy drug products exist that are FDA- approved prescription products or are appropriately marketed OTC, taking an unapproved prescription product is an unnecessary risk.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245048.htm