FDA Recommends Reclassifying Medications Containing Hydrocodone

The FDA is recommending restrictions on Vicodin – an addictive painkiller that has grown into the most widely prescribed drug in the U.S. – and other hydrocodone combination drugs. FDA wants limits on prescribed painkillers

In an important policy shift, the U.S. Food and Drug Administration is making the recommendation, which if approved, could reclassify hydrocodone-mixed drugs – opiates such as Vicodin and Lortab – from Schedule III of the Controlled Substances Act to Schedule II. Drugs in that class require a written prescription by a physician, cannot be refilled without subsequent prescriptions, and must be kept locked and carefully tracked by pharmacies. 

According to the University of Michigan Monitoring the Future study, Vicodin is the most abused prescription drug in the United States. Vicodin Abuse and Addiction And the CDC reports that the abuse of prescription opiates has increased dramatically in recent years, with more overdose deaths per year than heroin and cocaine combined. Vital Signs: Overdoses of Prescription Opioid Pain Relievers

The five “schedules” of drugs, as described by the Drug Enforcement Association (DEA), are determined by a drug’s addictive properties and potential physical and mental damage caused by dependency. DEA Drug Information

The FDA classifies every drug in this way – the lower the schedule, the more dangerous and addicting it is.

Schedule II is defined by the DEA as, “drugs with a high potential for abuse … with use potentially leading to severe psychological or physical dependence, while Schedule III substances have “a moderate to low potential for physical and psychological dependence.”

Earlier this year, an FDA advisory committee voted 19 to 10 to move the drugs to Schedule II. Committee members who voted “yes” noted that hydrocodone has the same high potential for abuse as drugs already labeled Schedule II, such as oxycodone. 

The FDA says it will formally request in early December that hydrocodone be rescheduled as a Schedule II drug.

The request for reclassification must be approved by officials in other agencies within the Department of Health and Human Services.