FDA CRACKS DOWN ON UNAPPROVED HYDROCODONE PRODUCTS

Pharmacists need to be aware that theFDA will take action against companiesmarketing unapproved prescription drugproducts containing hydrocodone—anarcotic used to treat pain and suppresscoughs. The action, however, does notaffect FDA-approved hydrocodone formulations.

The agency has received reports ofmedication errors associated with formulationchanges in unapproved hydrocodoneproducts and reports of confusionover the similarity of the namesof unapproved products to those ofapproveddrug products. As part of thedrug approval process, the agency considersthe possibility of medication errorsand name confusion to help preventpotential safety issues associated withthese factors. The agency is particularlyconcerned about improper labeling ofnon?FDA-approved hydrocodone coughsuppressants (antitussives) marketed forkids, and the risk of medication errorsinvolving unapproved products.

"Companies marketing these unapprovedproducts have not demonstratedthe safety and efficacy of these drugs,"said Steven K. Galson, MD, MPH, directorof the FDA's Center for Drug Evaluationand Research. "A case in point—nohydrocodone cough suppressant hasbeen established as safe and effectivefor children under 6 years of age andsome of these unapproved productscarry labels with dosing instructions forchildren as young as 2 years of age."

If a pharmacy receives a prescriptionfor an unapproved hydrocodone product,the pharmacist should call the prescribingphysician for an alternative treatment.Pharmacists also should educateparents and caregivers who might beusing unapproved hydrocodone coughsuppressants on other available options.

There are 8 FDA-approved coughsuppressant products containing hydrocodone,according to the agency'sWeb site. The approved products areTussionex Pennkinetic (UCB Inc), Tussicaps(Tyco Healthcare), HydrocodoneCompound (Actavis Mid Atlantic),Mycodone (Morton Grove), HomatroprineMethylbromide and HydrocodoneBitartrate (Actavis Totowa), Hycodan(Endo Pharmaceuticals), Tussigon(King Pharmaceuticals), and HydrocodoneBitartrate and HomatropineMethylbromide Syrup (Hi-Tech PharmacalCo Inc).

There also are various antitussive products,both prescription and OTC, thatdo not contain hydrocodone. The FDAadvises individuals to consult a healthcare professional for detailed guidanceon treatment options.