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."

"We assume that medicines for sale in the U.S. are properly approved," he added.

Dr. Ari Brown, a pediatrician in Austin, Texas, said most doctors would be surprised to hear this "because the ingredients -- decongestant, antihistamine, cough suppressent/mucolytic -- are all typically what you would see in a 'cough and cold' remedy."

"There are way too many of them to keep up with, so we would assume those would be FDA approved that way and thus, marketed as such," Brown told MedPage Today.

Still, neither the FDA nor the physicians we talked to expect Wednesday's action to have much of an impact on consumers -- although the agency doesn't know what percentage of the market these drugs account for. Most physicians will recommend over-the-counter cold products, if they recommend any at all.

"I'm not much on prescribing for coughs and colds," Green said. "[Patients] would be better off with a teaspoon of honey with a few drops of lemon juice in it, some chicken soup, hot tea, and rest."

Brown said she tries to "avoid writing a prescription just to make 'the parent feel better.' It's best to be honest and save the family some money."

Companies that have previously listed their products with the FDA will have to stop manufacturing them within 90 days and stop shipping the products within 180 days, Autor said.

Those that didn't previously list their products must stop manufacturing and shipping their products immediately.

This is the FDA's 17th action related to its Unapproved Drugs Initiative, which launched in June 2006.