FDA Pulls Plug on 200-Plus Unapproved Cough Syrups With Hydrocodone

ROCKVILLE, Md., Sept. 28 -- The FDA today ordered makers of more than 200 unapproved hydrocodone-containing cough suppressants to take them off the market, starting the end of next month.

The unapproved antitussives are prescription products that probably represent the majority of cough syrups prescribed by physicians, said Deborah M. Autor, J.D., director of compliance at the FDA's Center for Drug Evaluation and Research (CDER).

There are only seven FDA-approved hydrocodone-containing cough syrups, she said, so it is likely that the majority of prescriptions are for unapproved products. Moreover, many of the unapproved products have names much like one another or very similar to approved products, which may be confusing to physicians, pharmacists, and patient.

Autor said the FDA was giving the drug makers until Oct. 31 to stop the marketing and distribution of unapproved hydrocodone cough syrups that are labeled for use in children younger than six. The companies have until Dec. 31 to stop making the products and until March 31, 2008, to stop interstate shipment.

The announcement marked the latest action in an FDA campaign, launched in June 2006, against unapproved drugs. (See: FDA Orders Unapproved Cold Remedies Pulled From Shelves)

In most cases the products have been sold for decades, but in the 1960s Congress authorized the FDA to review drugs marketed from 1938 through 1962 to determine both safety and efficacy. In 1982, a hydrocodone cough syrup was reviewed as required by the Drug Efficacy Study Implementation (DESI) "and it was found to be safe and effective," Autor said. As a result of that action, all other hydrocodone cough syrups were required to submit to DESI review.

Seven companies did receive FDA approval for their products, but the rest -- more than 200 -- simply continued to market their products without approval. "They just took the shortcut," Autor said.

The seven approved hydrocodone-containing cough suppressants are:

• TussiCaps made by Tyco
• Tussionex/Pennkinetic by Celltech
• Hydrocodone compound by Actavis Mid Atlantic
• Mycodone by Morton Grove
• Homatropine methlybromide and hydrocodone bitartrate by Actavis Totowa
• Hycodan by Endo Pharmaceutical
• Homatropine methypromide by King Pharmaceutical.

Michael Levy, director of the division of new drugs and labeling compliance at CDER, said there had been reports of deaths associated with use of the unapproved products, although he didn't indicate how many deaths or associate them with a specific unapproved product.

Asked for clarification, Jason Woo, M.D., M.P.H., associate director for medical and scientific affairs at the office of compliance, said the FDA had received "more than 400 spontaneous reports of adverse events" with hydrocodone-containing antitussives," but had not sorted out the reports by approved or unapproved status."

Moreover, Autor said the FDA has no evidence to either prove or disprove the efficacy and safety of the 200-plus products. It was possible, she said, that the products were safe and effective, but the FDA has no data to decide.

Makers of the unapproved cough syrups still have the option of submitting products to the FDA for DESI review, she said.

Physicians or patients who have questions about the approval status of hydrocodone cough suppressants can check the FDA's website for a listing of approved and unapproved products, Autor said.