FDA to propose hydrocodone restrictions

The U.S. Food and Drug Administration (FDA) is planning to recommend a more restrictive classification of hydrocodone combination drugs to increase control of the drugs, the agency announced.

The decision would mean a reclassification by the U.S. Drug Enforcement Administration (DEA) of hydrocodone-containing drug products such as Vicodin from schedule III to the more restrictive schedule II.

By early December, the FDA plans to submit its formal recommendation to the U.S. Health and Human Services (HHS) to reclassify hydrocodone combination products into schedule II. The National Institute on Drug Abuse (NIDA) is expected to concur with the agency's recommendation, which will lead to a final decision by the DEA on the appropriate scheduling of these products, according to the FDA.

The ADA and American Association of Oral and Maxillofacial Surgeons have previously told federal regulators that the proposed reclassification could cause inconvenience, unnecessary suffering, and higher out-of-pocket costs for patients with legitimate needs for the medications, according to an ADA story.

Opioid analgesics, such as hydrocodone and oxycodone, have become a source of drug abuse among teens and adults, the ADA noted.

The ADA invites patients to visit MouthHealthy.org/rxabuse to learn how to keep prescription drugs from becoming harmful.

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