WASHINGTON – The US Food and Drug Administration on Wednesday said it wants 500 unauthorized prescription drugs for cough, cold and allergy symptoms pulled from the market because of risks to the public.
“We don’t know what’s in them, whether they work properly or how they are made,” FDA director of the Office of Compliance, Center for Drug Evaluation and Research Deborah Autor told reporters.
The FDA published a list of 500 medications that are available only through a doctor’s prescription, and said companies must “stop manufacturing them within 90 days and stop shipping the products within 180 days.”
Autor said “all or almost all” of the drugs are made in the United States.
“We believe there are doctors out there who continue to prescribe these drugs,” said Autor, noting that some of the drugs are listed in physicians’ desk reference books and advertised in medical journals.
Some of the more commonly known drug names include Cardec, Lodrane 24D, and Organidin, she said. Another, called Pedia-Hist, is labled for children as young as one year old but has not been cleared by the FDA.
Charlie Lee, a doctor who participated in the FDA conference call with reporters, said the drugs are mainly cough and cold combination formulas and that “sedation, drowsiness, irritability” are among the complications reported.
However, the FDA noted that such reports were “limited” and said it was unclear how many of the drugs were actually on the market.
It was also unknown how many people could be taking them because most people treat such symptoms with drugstore remedies.