Unapproved cold and allergy drug crackdown by FDA

by Aimee Keenan-Greene

The U.S. Food and Drug Administration is taking action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products being  illegally marketed in the United States.

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

These 'unapproved' prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality.  Some may contain a potentially risky combination of ingredients, while others marketed as “timed-released” may release active ingredients too slowly, too quickly, or inconsistently.

FDA has also received reports that some of the products have names that look or sound similar to other products—a problem that could contribute to medication errors.

Health experts are concerned some products are inappropriately labeled for use by infants and young children. Many of the unapproved drug products covered by today’s announcement contain the same ingredients as the over-the-counter cough and cold products that were the subject of a 2008 FDA public health advisory.

That 2008 advisory says non-prescription cough and cold products should not be used for infants and children under 2 years of age because of serious and potentially life-threatening side effects. Many manufacturers voluntarily withdrew products labeled for children under 2 years old, and some were relabeled to state they were not for use by children under 4 years old.

Companies that previously listed products subject to today’s action with FDA must stop manufacturing within 90 days and stop shipping 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.

For the full list of unapproved products, click here. 

Consumers taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss alternatives.


Additional Resources: 

Unapproved Drugs Initiative

Unapproved Prescription Cough, Cold, and Allergy Products Federal Register Notice (PDF)

Unapproved Drugs Enforcement Actions (By Drug Class) 

If you are taking a prescription medicine for cough, cold, or allergy symptoms and you want to know if it is an approved drug, use one of the FDA resources listed. 

Drugs@FDA (contains FDA-approved drugs) www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
If a product is not included here, the search results will say “Your search term did not return any results.” 

The Orange Book List of Approved Drug Products: www.accessdata.fda.gov/scripts/cder/ob/default.cfm If a product is not FDA approved, the search results will say, "No matching records found." 

The National Drug Code (NDC) Directory of prescription drugs and insulin products:www.accessdata.fda.gov/scripts/cder/ndc/default.cfm 

To dispose of your unused, unapproved prescription cold, cough,
or allergy products: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm