Drug manufacturers have 90 days to stop making unapproved prescription medications to treat cold, cough, and allergy symptoms, officials at the Food and Drug Administration announced on March 2.
The FDA issued a list of about 500 unapproved prescription products that should be pulled from the market. These products were never evaluated by the FDA but continue to be prescribed. In many cases, they have been on the market for years, are listed in the Physicians' Desk Reference, and are advertised in medical journals.
Physicians may not be aware that the drugs were not approved, Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research, said during a press conference.
"This action is necessary to protect consumers from the potential risks posed by unapproved drugs because we don’t know what's in them, whether they work properly, or how they are made," Ms. Autor said.
The FDA announcement is part of a broader crackdown on unapproved drugs that began in 2006. But Ms. Autor said that agency officials have particular concerns about these cold, cough, and allergy medications. For example, some of the drugs are labeled as time-release formulations, but without evaluation by the FDA, it's unclear whether the drugs are delivering their active ingredients as labeled, Ms. Autor said. The active ingredient may be released too slowly, too quickly, or not at all, she said.
Ms. Autor said the FDA is also concerned because some of the unapproved drugs are labeled for use in children younger than age 2 years. Some of the unapproved drugs also have names that are similar to the names of other drugs, which could lead to confusion when prescriptions are filled. And some of the drugs on the FDA's list contain combinations of the same types of ingredients, such as two or more antihistamines, which can lead to oversedation.
If a company has registered its unapproved products with the FDA, it will have 90 days to stop manufacturing and 180 days to stop shipping all products. However, FDA officials said there are likely more unapproved prescription drugs that have never been registered with the agency. Those products must be pulled from the market immediately.
"We do not anticipate today's action will have a major negative impact on consumers or health professionals because there are multiple other products available to treat cough, cold, and allergy symptoms, either as an FDA-approved prescription drug or an over-the-counter drug that follows appropriate FDA standards," Ms. Autor said. "We do anticipate that today’s action will have a significant positive impact by improving the safety of the American drug supply."