FDA Panel Calls For Restrictive Rules for Vicodin, Hydrocodone Painkillers

A panel of drug safety advisers is calling for new limits on the use of hydrocodone-based painkillers, such as Vicodin, in the face of mounting prescription drug overdoses and abuse. 

The FDA’s drug safety advisory panel voted 19-10 last week to recommend that hydrocodone be reclassified as a Schedule II controlled substance, which would group Vicodin with drugs like OxyContin. If the FDA agrees, the change would limit how many oxycodone-based pills doctors could prescribe to patients.

Currently Vicodin and similar hydrocodone-based drugs are classified as Schedule III controlled substances, which require less stringent oversight. If they are reclassified as Schedule II, not only would doctors be restricted in how many could be prescribed to one patient, but there would also be more strict storage and handling rules to prevent theft and abuse.

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The advisory committee’s vote is non-binding, but the FDA usually weighs the committee’s decisions heavily when setting its own regulations and policies.

Those who voted against the change held out little hope that the reclassification would have a significant impact on the number of deaths caused by abuse and overdose. They pointed out that OxyContin and other oxycodone-based drugs started out in the Schedule II classification, and that did little to deter abuse.

Pain Medication Abuse and Misuse Seen As Epidemic

Last year, the U.S. Centers for Disease Control and Prevention (CDC) declared that unintentional prescription drug overdose deaths had hit “epidemic” levels in the U.S.

Misuse and accidental overdoses of painkillers like OxyContin and morphine have driven the skyrocketing numbers, with opioid painkillers responsible for more deaths than cocaine and heroin combined since 2003.

In 2007, there were about 27,000 unintentional prescription drug overdose deaths in the United States, the CDC reported. Since 2008, prescription drug overdoses have accounted for more deaths than traffic accidents.

The two-day advisory panel meeting comes about two weeks after the FDA issued a new draft guidance on deterring abuse of opioid drugs. The FDA’s guidance favored an industry-led approach, encouraging companies to use abuse-deterrence technology for powerful painkillers.

The meeting also follows follows recent FDA advisory committee recommendation against approval of a new hydrocodone-based opioid drug, Zohydro ER, used for relief of chronic pain. The drug, which is manufactured by Zogenix Inc., was rejected by the committee after it deemed the single-entity narcotic to be at high risk of abuse, like many other single and double-entity narcotic drugs such as Oxycontin and Methadone.


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