The FDA took action this week to remove more than 500 unapproved prescription cough, cold and allergy medications from the market due to excessive amounts of active ingredients and problems with extended release formulations.
Some clinicians may not be aware that these products are not FDA-approved as many are listed in the Physician’s Desk References and may be advertised in medical journals, according to Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
“We don’t know what’s in them, whether they work properly, or how they are made,” Autor said during a press briefing.
She explained that three of the mediations in question released 85% of the active ingredient within 30 minutes instead of the 8 to 12 hours listed on the label, whereas another released only 25% of the active ingredient in a 12-hour period.
Additionally, some of the medications claim indications for children aged younger than two years, despite FDA recommendations from 2008 warning against administering any cough or cold product to this age group.
Another worry is the potential for over-sedation due to interactions between two or more active ingredients, as well as potential for abuse.
“Some of these nonapproved drugs have been on the market for years and contain first generation sedating antihistamines,” said Thomas B. Casale, MD, executive vice president of the American Academy of Allergy and Immunology, in a press release. He added that newer, nonsedating antihistamines that have fewer associated side effects are now available.
“There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products available to treat cough, cold and allergy symptoms,” Autor said, noting that the action should have little to no negative impact on consumers.
This is the 17th action that the FDA has initiated on a drug class as part of its Unapproved Drugs Initiative since the program’s inception in June 2006.
The FDA is requiring manufacturers that have previously listed products subjected to the action with the agency to stop production within 90 days and cease shipping in 180 days. Those that have not listed their products with the FDA must stop manufacturing and shipping immediately.
Health care professionals can view a list of the unapproved products, here.
The FDA encourages health care professionals and consumers to report adverse effects or medication errors from unapproved prescription cough, cold and allergy products to MedWatch.