FDA Panel Votes for Tougher Restrictions on Hydrocodone

Panel votes in favor of moving hydrocodone combo products into Schedule II category

FRIDAY, Jan. 25 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel met Thursday and Friday to discuss the fate of certain painkillers that contain the opioid known as hydrocodone, concluding in a vote in favor of moving hydrocodone combination products into the more restrictive Schedule II category of controlled substances.

The hydrocodone combination products include the commonly prescribed Vicodin, Lortab, and Norco.

The U.S. Drug Enforcement Administration (DEA) requested that an FDA advisory panel conduct the review. Currently, hydrocodone combination drugs are classified as Schedule III drugs but the agency wants them recategorized into the more tightly controlled Schedule II designation. Other opioid medications, including Oxycontin and Percocet, are already classified in the higher Schedule II category.

"In making a determination on whether to control or reschedule a drug, the DEA must consider eight factors: (1) the drug's actual or relative potential for abuse, (2) scientific evidence of its pharmacological effect, if known, (3) the state of current scientific knowledge regarding the drug or other substance, (4) its history or current pattern of abuse, (5) the scope, duration, and significance of abuse, (6) what, if any, risk there is to the public health, (7) its psychic or physiological dependence liability, (8) whether the substance is an immediate precursor of a substance already controlled under this title," according to the Addendum to the FDA Background Document for the Jan. 24 to 25, 2013, Drug Safety and Risk Management Advisory Committee Meeting.

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