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

March 15, 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 cold and cough products that were subject to a 2008 FDA public health advisory. That advisory said that children under the age of 2 years should not be given nonprescription cough and cold products because of the potential for serious and even life-threatening side effects. Following publication of the advisory many manufacturers voluntarily withdrew products labeled for use by children under 2 years of age, and some relabeled products stating that they were not for use by children under 4 years of age.

Autor notes that there are many products - both prescription and over-the-counter - 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 adds.

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 the FDA's announcement and stop shipping them within 180 days.

For FDA’s list of unapproved cough, cold, and allergy products, visit this site: http://1.usa.gov/hom6A1.