FDA seeks curbs on drugs that contain opioid painkiller hydrocodone

October 24, 2013

The Food and Drug Administration recommended tighter restrictions Thursday on products that contain hydrocodone, an opioid painkiller present in commonly prescribed drugs.

Until now, Vicodin and other products that contain less than 15 milligrams of hydrocodone have been classified as Schedule III controlled substances. The FDA recommends reclassifying them more restrictively — potentially as Schedule II products, in line with opioid painkillers such as oxycodone and morphine.

The products would become harder to obtain, both by addicts and by legitimate patients. Physicians are not allowed to call in a prescription for a Schedule II product to a pharmacy; patients must present a written prescription.

In addition, patients would not be allowed as many refills before returning to see their doctors, potentially representing a hardship for patients in chronic pain.

The proposed change was urged by the Drug Enforcement Administration, which is battling a rising tide of prescription drug abuse. The change must be approved by the Department of Health and Human Services and the DEA, which will make a final scheduling decision.

Nearly three of four prescription drug overdoses are caused by opioid painkillers, according to the Centers for Disease Control and Prevention.

Janet Woodcock, director of the FDA’s pharmaceuticals division, said in a statement that the agency has, over the past few years, been “challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse.”

In the end, she said, the level of opioid abuse and the “tremendous amount of public interest” in the matter led the agency to recommend a change.

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