FDA Cracks Down On Unapproved Cough Medicines

Friday, September 28th 2007, 9:40 am

By: News On 6

WASHINGTON (AP) _ Government health officials on Friday gave drug companies until Oct. 31 to stop making and selling any unapproved medicines labeled for use by children younger than 6 that contain the painkiller and cough suppressant hydrocodone.

The move by the Food and Drug Administration is part of a broader effort to remove from sale an estimated 200 unapproved prescription cough medicines made with the narcotic.

Manufacturers of any other unapproved hydrocodone medicines, beyond those intended for young children, must stop making them by Dec. 31 and cease shipping them by March 31, 2008, the FDA said. It said the order applies to most of the hydrocodone formulations sold as cough medicines.

The order does not apply to other hydrocodone formulations, including the seven cough suppressants made with the narcotic that do have FDA approval. Nor does it apply to pain-relief drugs like Vicodin, which combine hydrocodone and acetaminophen.