FDA Proposing Tighter Restrictions on Hydrocodone Products

By Kristin J. Kelley

The FDA is recommending that hydrocodone combination products (e.g., hydrocodone plus aspirin or acetaminophen) be reclassified from Schedule III to Schedule II to address concerns over "epidemic proportions" of misuse.

The regulations would increase controls on drugs like Vicodin and Lortab by reducing the number of refills patients can get and preventing doctors from calling in prescriptions over the phone. In an interview with the New York Times, the director of the FDA's Center for Drug Evaluation and Research said the changes could take effect as early as next year. According to the Times' report, the number of deaths from narcotic painkillers has quadrupled since 1999.

The FDA also approved a new hydrocodone product (hydrocodone bitartrate extended-release capsules, marketed as Zohydro ER) for long-term treatment of severe pain. The drug, the first single-entity (i.e., not combined with an analgesic), extended-release hydrocodone product, is a Schedule II substance.