FDA Panel Seeks New Limits on Powerful Painkiller Hydrocodone

An advisory panel of the Food and Drug Administration (FDA) has recommended that the agency put tighter restrictions on the common painkiller hydrocodone, an ingredient in brand-name drugs such as Vicodin. The vote of the panel was 19-10: a majority to be sure, but certainly not unanimous.

Hydrocodone/paracetamol 5/500 tablets (Mallinckrodt). Photo: Elbreapoly

The panel is calling for hydrocodone, an opioid, to be made a Schedule II drug, which will place it in the same category as morphine, fentanyl, and oxycodone. Hydrocodone is currently in Schedule III.The FDA is likely to follow the panel's advice, according to the New York Times. The agency is seeking to limit widespread abuse of painkillers; the Times article notes that the number of deaths from pain drugs has increased fourfold since 1999.

Among other things, being in the more restrictive Schedule II would mean that hydrocodone prescriptions would be harder to refill (a patient would need to get a new prescription to get a refill). The drug could also not be obtained by faxed prescriptions.

Hydrocodone is the most frequently prescribed pain medication in the U.S., and some experts say it is because of the misconception in the medical community that it is not as dangerous or addictive as Schedule II drugs such as Percocet or methadone.

Other professionals question whether putting hydrocodone in Schedule II would actually limit its abuse, and may make it harder to obtain for patients suffering from pain.

The FDA panel is hoping to make the nation's most-prescribed painkiller less of a killer.