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FDA moves for stricter hydrocodone controls

bunchofpillsThe U.S. Food and Drug Administration has recommended reclassifying hydrocodone-containing painkillers like Vicodin from Schedule III drugs to the more restrictive Schedule II, a move that would bring such medications in line with opioid painkillers such as oxycodone and morphine.

In January, an expert panel advising the FDA voted 19 to 10 in favor of the more stringent prescribing requirements. Proponents of the reclassification have noted hydrocodone’s abuse potential (such products are currently the most-abused prescription medicine behind oxycodone), while critics have argued that the move would hinder legitimate pain patients from obtaining treatment.

The reclassification must be approved by the Department of Health and Human Services and the Drug Enforcement Administration, which will make a final scheduling decision.

Separately in September, the FDA announced new safety labeling changes for extended-release and long-acting opioid analgesics such as OxyContin. The updated labels must state that such medications are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

In addition, because of the risk of addiction and abuse “even at recommended doses,” as well as the greater risks of overdose and death, the drugs must be labeled as “reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” the agency said.

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