FDA removes more than 1,000 unapproved cold, cough and allergy drugs from market
By JENNIFER WALKER-JOURNEY

Date: March 3rd, 2011

Various prescription and over-the-counter cough, cold and allergy drugs will be removed from the market because they were never approved for use and may be dangerous to consumers, according to the Food and Drug Administration (FDA). The drugs have never been evaluated by the federal agency for safety, effectiveness and quality.

People may be at greater risk for harm when taking these drugs with other FDA-approved prescription or appropriately marketed over-the-counter medications. The agency fears doctors and health care providers may be unaware that the drugs are not FDA approved and may have unknowingly prescribed them to patients.

The medications in question are used to relieve symptoms associated with the common cold or upper respiratory allergies, such as coughing, chest congestion, nasal congestion, itchy eyes, and sneezing.

More than 1,000 different cough, cold and allergy medications are included in the market withdrawal. A full list of drugs can be found on the FDA website. All companies that manufacture, repack, or re-label drugs in the United States are required  to register and list all commercially marketed drugs with the FDA, though not all do so. Therefore, the list of unapproved prescription cough/cold/allergy drug products may include drugs that are no longer being marketed and/or may not include prescription cough/cold/allergy drug products that are currently being marketed if the drug firm has not listed or updated their information.

Any unapproved prescription oral cough/cold/allergy drugs that are not on this list are not entitled to any grace period and are subject to immediate enforcement action.

Consumers who believe they are taking an unapproved prescription cough, cold or allergy product should contact their health care provider to discuss alternative medication. Any side effects should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/Medwatch

Related News