Entries in Unapproved (1)


FDA Warns of Unapproved Rx Cold Meds

Photo Courtesy - Getty Images(WASHINGTON) -- The U.S. Food and Drug Administration announced Wednesday there are nearly 500 prescription cough, cold and allergy drugs that are not approved and should not be on the market.

The FDA highlighted brands such as Cardec, Lodrane, Organidin and Pedia-Hist, many of which, the agency says, have issues with excessive amounts of active ingredients.  Deborah Autor, director of compliance at the Center for Drug Evaluation and Research, also noted that some extended-release formulas do not function properly and others consist of two or more active ingredients, raising the risk of over-sedation.

"We don't know what's in them, whether they work properly, or how they are made," Autor told reporters.

Autor added that many of these drugs had failed FDA testing, but many physicians are unaware of their FDA status, particularly because they are still listed in the Physicians Desk Reference and can be advertised in medical journals.

Manufacturers of the drugs previously listed with the FDA, but are unapproved, must stop producing them within 90 days and stop shipping within 180 days, Auto said.  Those that have not filed with the FDA must cease manufacturing and shipping of their products immediately.

A complete list of the unapproved prescription products can be found at the agency's website.

Copyright 2011 ABC News Radio 

ABC News Radio