JULY 01, 2008

Pharmacists need to be aware that the FDA will take action against companies marketing unapproved prescription drug products containing hydrocodone—a narcotic used to treat pain and suppress coughs. The action, however, does not affect FDA-approved hydrocodone formulations.

The agency has received reports of medication errors associated with formulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to those of approved drug products. As part of the drug approval process, the agency considers the possibility of medication errors and name confusion to help prevent potential safety issues associated with these factors. The agency is particularly concerned about improper labeling of non?FDA-approved hydrocodone cough suppressants (antitussives) marketed for kids, and the risk of medication errors involving unapproved products.

"Companies marketing these unapproved products have not demonstrated the safety and efficacy of these drugs," said Steven K. Galson, MD, MPH, director of the FDA's Center for Drug Evaluation and Research. "A case in point—no hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age."

If a pharmacy receives a prescription for an unapproved hydrocodone product, the pharmacist should call the prescribing physician for an alternative treatment. Pharmacists also should educate parents and caregivers who might be using unapproved hydrocodone cough suppressants on other available options.

There are 8 FDA-approved cough suppressant products containing hydrocodone, according to the agency's Web site. The approved products are Tussionex Pennkinetic (UCB Inc), Tussicaps (Tyco Healthcare), Hydrocodone Compound (Actavis Mid Atlantic), Mycodone (Morton Grove), Homatroprine Methylbromide and Hydrocodone Bitartrate (Actavis Totowa), Hycodan (Endo Pharmaceuticals), Tussigon (King Pharmaceuticals), and Hydrocodone Bitartrate and Homatropine Methylbromide Syrup (Hi-Tech Pharmacal Co Inc).

There also are various antitussive products, both prescription and OTC, that do not contain hydrocodone. The FDA advises individuals to consult a health care professional for detailed guidance on treatment options.