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FDA targets unapproved prescription cold meds
March 2nd, 2011
03:40 PM ET

FDA targets unapproved prescription cold meds

Companies that make, distribute or market unapproved prescription cough, cold and allergy medications were put on notice Wednesday by the Food and Drug Administration that their products can't be legally marketed in the United States.

The FDA says the safety, effectiveness and quality of 27 active ingredients in approximately 500 unapproved drugs have not been evaluated by the agency. Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said the agency doesn't know what's in these drugs or how they were made.

"Removing these unapproved products from the market will reduce potential risks to consumers, " Autor said. "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."

Autor says consumers could be at greater risk with these products than with FDA-approved prescription drugs and over-the-counter products. She says some of them contain a combination of the same types of drugs, raising the risk of over-medication. Some are marketed as time-released but may release active ingredients to slowly or too quickly. "We do not know if they're safe. We do not know if they are effective. We do not know if they are of good quality. We don't know what they are."

Another concern is that some are not labeled appropriately for use in young children. Many of these ingredients were the subject of a 2008 public health advisory the FDA issued on OTC cough and cold products. That advisory warned that non-prescription products should not be given to children under 2 years of age because of the possibility of serious, life-threatening side effects.

Almost all are made in the U.S., and many of these drugs have been on the market for years, before a 1962 law that required products be proved safe and effective before getting approval. Despite that law, many remained on the market illegally. The Drug Listing Act of 1972 required companies to submit a list their unapproved drugs to the FDA.

In 2006, the agency announced its Unapproved Drugs Initiative, an effort to bring all unapproved drugs into compliance. Manufacturers were asked to submit a list of their unapproved products to the FDA.

Many of them have names unfamiliar to most: cardec, lodran24D, organidin, pedia-hist - all combinations of antihistamines, decongestants or antitussives (cough suppressants). Autor says many doctors are unaware that the drugs are not approved and prescribe them unknowningly.

Dr. Michael Levy, director, division of New Drugs and Labeling Compliance, Office of Compliance, CDER, FDA says a handful of adverse events linked to these products have been reported. They have not been serious, Levy says, mostly sedation, drowsiness and irritability linked to antihistamines and decongestants. He believes these events are underreported, which is why regulators need to act now.

The agency is giving companies making or selling unapproved products 90 days to stop manufacturing and 180 days to stop shipping. Companies that have not listed their unapproved products with the FDA must remove them from the market immediately.


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