FDA panel recommends restriction of pain killers with hydrocodone

Robin Wulffson MD's picture
hydrocodone, Vicodin, abuse, addiction, deaths, narcotics

On January 25, a Food and Drug Administration (FDA) advisory panel voted to place new restrictions on common types of narcotic painkillers that contain hydrocodone such as Vicodin and generic equivalents (Vicodin is a blend of hydrocodone and the non-narcotic painkiller acetaminophen). The recommendation is focused on reducing widespread abuse of the potent narcotic, which has sparked a significant rise in addiction and overdose deaths. If approved, the restrictions will impact the way physicians prescribe medications that are ingested by tens of millions of Americans.

According to the Centers for Disease Control and Prevention (CDC), more than 16,500 individuals died after overdosing on opioid-based painkillers in 2010, the most recent data available. The agency notes that no other class of drugs, legal or illegal, is responsible for as many deaths. After hearing two days of testimony, the FDA’s safety advisory panel voted 19-10 to recommend that products containing hydrocodone should be reclassified as Schedule II controlled substances, along with other narcotic painkillers such as oxycodone. Hydrocodone products are currently in Schedule III. Although, the recommendations of the advisory panel are not binding, it is likely that the FDA will comply with the recommendation.

If approved, physicians would be restricted in how many pills they could prescribe at one time. In addition, the medications would be subject to more stringent handling and storage rules. A spokesman for the Generic Pharmaceutical Association, which represents several opioid manufacturers, noted that drug companies and pharmacies would abide by whatever the FDA decides; however, he cautions that the change in schedule would not in itself be enough to solve the problem of abuse.


For a number of years, drug safety groups and family members of overdose victims have lobbied for the restrictions on hydrocodone. They argue that the hydrocodone products are just as addictive as more tightly controlled drugs such as OxyContin. Those opposed to the restriction claim that the move could make it harder for legitimate patients to get their medications, and make physicians more reluctant to prescribe them.

According to IMS Health Inc., which tracks pharmaceutical sales, the generic version of Vicodin is the most widely prescribed medication in the United States. Medications containing hydrocodone are commonly prescribed to treat acute pain in patients such as those who have bone fractures or are recovering from surgery. In 2011, approximately 47 million individuals were given prescriptions for hydrocodone, according to the FDA. Furthermore, according to a 2005 study by the International Narcotics Control Board, Americans use 99% of the world’s hydrocodone supply.

The current recommendation is not the first to be focused on hydrocodone. Last December, an FDA advisory panel voted against approving the first pure hydrocodone product due to fears that it could become a widely abused drug. The FDA must also soon decide whether to disallow inexpensive, generic copies of two widely abused drugs, OxyContin and Opana, from being marketed in the US this year. According to the FDA, the generic copies currently lack the crush-resistant formulations of the brand name drugs, potentially making them attractive to those who wish to abuse them.

Reference: FDA

See also:Teens responsible for much prescription drug abuse
Prescription narcotic abuse in the US rampant in some states
Closer scrutiny of prescription drugs recommended to protect public
Drug addicted newborns: a national disgrace


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