Tag Archives: reclassification

DEA clamps down on hydrocodone

HydrocodoneHydrocodone, the nation’s most widely prescribed painkiller, will now be in the same category as other frequently abused medications such as OxyContin and fentanyl. The agency said Friday it had published a rule to reschedule hydrocodone combination products — which include Vicodin and Norco — from Schedule III to the more restrictive Schedule II of the Controlled Substances Act.

Americans consume 99% of the hydrocodone produced worldwide; because of the perception that such products are less risky than other narcotic painkillers, they are widely prescribed by general practitioners and dentists, according to this article.

Combination hydrocodone products are currently classified as Schedule III drugs, meaning that prescriptions can be written with five refills and pharmacies are not required to lock them in a safe.

Since 2007, more U.S. prescriptions were written for the combination of hydrocodone and acetaminophen than any other drug. In 2012, that was over 135 million prescriptions, or one prescription for every 2.3 men, women, and children in the U.S. that year, according to this article.

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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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FDA mulls hydrocodone reclassification

This week, the U.S. Food and Drug Administration is set to conduct a two-day hearing on whether hydrocodone products such as Vicodin should be more highly regulated like other narcotics like OxyContin and morphine, this article reports. FDA researchers said in recent briefing documents that while chronic pain patients taking hydrocodone products might develop moderate or low physical dependence, they would not be expected to develop addiction, the article says. But critics say hydrocodone is potent and highly addictive, and that updating the drug’s classification could help bring the prescription drug addiction epidemic under control, according to the article.

Last year, pharmacy interest groups defeated an amendment to the FDA Safety Innovation Act that aimed to change the classification of hydrocodone-containing pain relief products from Schedule III to the more-restrictive Schedule II.

Combination hydrocodone products such as Vicodin and Norco are currently classified as Schedule III drugs, meaning that prescriptions can be written with five refills and pharmacies are not required to lock them in a safe.

The amendment to the Prescription Drug User Fee Act (PDUFA) re-authorization bill would have rescheduled hydrocodone from Schedule III to Schedule II, putting hydrocodone painkillers into the same category as OxyContin and Percocet. Hydrocodone is the most-prescribed prescription drug in the U.S., with 131.2 million prescriptions written in 2010 alone.

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