FDA Takes Aim at Unapproved Rx Cold Meds
March 2, 2011— -- The U.S. Food and Drug Administration is going after nearly 500 unapproved prescription cough, cold, and allergy drugs that shouldn't be on the market, the agency announced today.
The products include brands such as Cardec, Lodrane, Organidin, and Pedia-Hist, and many have issues with excessive amounts of active ingredients or extended-release formulas that don't function properly, according to Deborah Autor, director of compliance at the 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 telephone press briefing.
The full list of affected prescription products is available on the agency's website.
Many of the time-release formulations failed FDA testing, Autor said. For instance, three products released 85 percent of the active ingredient within 30 minutes, instead of the 8 to 12 hours it advertised.
On the other hand, one product dispensed only 25 percent of the active ingredient over 12 hours, she said.
The agency is also troubled by unapproved products that combine two or more active ingredients, notably antihistamines, which can raise the risk of oversedation and other side effects, Autor said.
She said the agency has seen a handful of related adverse event reports such as increased drowsiness or irritability.
The agency also took issue with the fact that some of the products claim to be "indicated" for children under 2, although in 2008 the FDA warned that this age group should not be given over-the-counter cough and cold products at all.
Many physicians are unaware that these products are unapproved, Autor said, especially since they are listed in the Physicians Desk Reference and may be advertised in journals or brought into doctors' offices by sales reps.
Dr. Lee Green, a professor of family medicine at the University of Michigan, said he's "quite certain that very few physicians are aware of them being unapproved, and would be as surprised as I was to hear that there were unapproved drugs on the market at all."
