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FDA Votes to Limit Vicodin, Hydrocodone Painkillers


January 28, 2013 — In an effort to curb prescription painkiller abuse, a U.S. Food and Drug Administration (FDA) advisory panel has voted 19-10 to re-classify hydrocodone from a Schedule III to a Schedule II medication.

The FDA will now decide whether to recommend the change to the Department of Health and Human Services, which has the final say. The move would place painkillers like Vicodin in the same category as OxyContin, Percocet, and fentanyl.

The new restrictions would likely have a dramatic impact in the United States, where approximately 100 million Americans suffer from chronic pain, and 47 million Americans were prescribed hydrocodone in 2011. Doctors would only be able to prescribe a 3-month supply of the drug, and patients would need to schedule an appointment to obtain a new written prescription written instead of having it called in to a pharmacy.

Some are concerned that restricted access to hydrocodone would disproportionately affect the elderly and people in rural areas, who may find it difficult to visit their doctor once every three months to get a new prescription.

However, others are concerned about the burgeoning problem of painkiller addiction and abuse. These advocates want doctors to be more cautious about issuing painkillers, and they want pharmaceutical companies to be less aggressive about marketing the drugs.

Many organizations have called on the FDA and Congress to enact stricter measures regarding Vicodin. The FDA advisory panel was created at the request of the Drug Enforcement Agency. The American Academy of Pain Medicine sent a letter to the panel to express their support for re-classifying hydrocodone. During two days of testimony, parents of children who died from prescription painkiller overdoses expressed their desire to have the drugs restricted from the general population.

Until recently, efforts to strengthen regulations of hydrocodone have failed. The FDA rejected a similar measure in 2008. In 2012, Congress rejected legislation to re-classify hydrocodone under heavy lobbying pressure from the pharmaceutical industry.

It is possible that the FDA will reconsider their previous decisions in light of new data. According to the Centers for Disease Control (CDC), every year approximately 15,000 Americans die from prescription painkiller overdoses. This rate has quadrupled since 1999.

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