FDA Votes to Limit Vicodin, Hydrocodone Painkillers

January 28, 2013 — An advisory panel to the U.S. Food and Drug Administration (FDA) voted 19-10 to strengthen restrictions on painkillers that contain hydrocodone, such as Vicodin.

The drugs are currently Schedule III, but the panel wants them recategorized as Schedule II drugs, similar to Oxycontin, Percocet, and fentanyl. Doctors can only prescribe a 3-month supply of a Schedule II drug instead of a 6-month supply, and they must write the prescription instead of calling it in to a pharmacy.

According to the U.S. Food and Drug Administration (FDA), hydrocodone was prescribed to 47 million patients in 2011, making it the most widely-prescribed medication in the United States. Unfortunately, as the popularity of hydrocodone has grown, so has concern about its potential for addiction and abuse. Many drug-safety advocates want pharmaceutical companies to stop marketing hydrocodone so aggressively, and get doctors to be more cautious about writing prescriptions.

The FDA panel was created at the request of the Drug Enforcement Administration, and members included pain doctors, scientists, and other experts. Testimony was heard from emotional family members of people who died from prescription painkiller overdoses. During the 2-day hearing, many argued that uncontrolled access to the drugs has made hydrocodone one of the most frequently-abused narcotic medications. The American Academy of Pain Medicine sent the panel a letter saying it did not oppose moving hydrocodone to a Schedule II medicine.

Officials at the FDA will now consider the advisory panel’s vote and decide whether to recommend that the Department of Health and Human Services re-classify hydrocodone. The FDA rejected a similar request in 2008, and similar legislation failed to pass in Congress in 2012 after heavy lobbying by the pharmaceutical industry.

The FDA will follow the panel’s recommendation in light of new data. Since 1999, the number of deaths from painkillers has quadrupled. According to the Centers for Disease Control and Prevention (CDC), about 15,000 Americans die from painkiller overdoses every year.

However, for the estimated 100 million Americans suffering from chronic pain, many are concerned that restricting access to hydrocodone will disproportionately harm many patients — especially those with disabilities, the elderly, and patients in rural areas. These patients may not be able to visit a doctor every three months to get a new prescription.