All of the unapproved cough, cold and allergy drugs affected by the FDA’s order came to market before a 1962 federal law required that medications be evaluated by the agency for safety and effectiveness prior to being sold. A complete list of the unapproved drugs covered by the FDA’s order is available here.
According to the FDA, these cough, cold and allergy medications pose unnecessary risk to consumers, especially when there are numerous other FDA-approved drugs available for treatment of cough, cold, and allergy symptoms. The FDA’s concerns include:
• Some of the medications may have potentially risky combinations of ingredients.
• Those marketed as “timed-release” may release active ingredients too slowly, too quickly, or inconsistently.
• Some of the drugs have names that look or sound similar to other products, which could contribute to medication errors.
• Some of the products are inappropriately labeled for use by infants and young children. In 2008, an FDA advisory that warned against using over-the-counter medications in children under age 2.
“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,” Deborah Autor, compliance director at FDA’s Center for Drug Evaluation and Research, said in a statement issued by the agency.
According to the FDA, many doctors are unaware of the unapproved status of these drugs and have continued to unknowingly prescribe them because their labels do not disclose that they lack FDA approval.
Under the FDA’s order, most manufacturers have 90 days to stop making the drugs on the list and 180 days to stop shipping them. However, some have been required to stop manufacturing and shipping the drugs immediately.
The FDA’s crackdown on the unapproved cold, cough and allergy drugs is being praised by some experts.
“I wasn’t actually aware, and I don’t think many physicians were aware, that you can prescribe a drug that isn’t approved,” Dr. Richard S. Irwin, an expert on coughs at the University of Massachusetts and editor in chief of the journal Chest told The New York Times.
According to a Wall Street Journal report, the FDA began cracking down on unapproved drugs in 2006, out of a concern that the medicines present a safety risks. This marks the agency’s 17th action against unapproved drugs in more than a dozen categories.