FDA to remove unapproved cough, cold, and allergy drugs from market

March 11, 2011

FDA recently announced its plans to remove certain unapproved prescription medicines used to treat cough, cold, and allergy symptoms.

FDA recently announced its plans to remove certain unapproved prescription medicines used to treat cough, cold, and allergy symptoms.

"Removing these unapproved products from the market will reduce potential risks to consumers from products that have never been evaluated by the FDA for safety, effectiveness, and quality," said Deborah Autor, compliance director at FDA's Center for Drug Evaluation and Research.

The drugs in question may contain potentially risky combinations of ingredients, while others-marketed as "time-release"-may release ingredients too slowly, too quickly, or inconsistently, said FDA officials. Some of these drugs are also marketed with names that look or sound similar to other products and could lead to medication errors.

FDA health experts also emphasize that some of these products are inappropriately labeled for use by infants and young children. They point out that many of these unapproved products contain the same ingredients as those over-the-counter (OTC) cold and cough products that were subject to a 2008 FDA public health advisory. That advisory said that children under aged 2 years should not be given non-prescription cough and cold products because of the potential for serious and even life-threatening side effects. Following the advisory many manufacturers voluntarily withdrew products labeled for use by children under aged 2 years, and some relabeled products stating they were not for use by children under aged 4 years.

Autor noted that there are many products-both prescription and OTC-available to consumers for treatment of cough, cold, and allergy symptoms. Therefore, the removal of the unapproved products should not create problems for consumers, she added.

FDA said that some manufacturers will have to stop making and shipping their products immediately.  Most manufacturers, however, must stop making the products within 90 days of FDA's announcement and stop shipping them within 180 days.

To view the products to be removed from the market, visit http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm245106.htm.