ADEA Washington Update

Food and Drug Administration Seeks to Curb Painkiller Abuse

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New Food and Drug Administration (FDA) labeling rules announced September 10 will change the wording on labels for “extended release” and “long-acting” opioid analgesic painkillers such as OxyContin, in an attempt to prevent abuse.

Although the current labels of such drugs say they should be used for “moderate to severe pain,” the new rules will drop the word “moderate” and specify that the pain must be “severe enough” to mandate around-the-clock treatment for patients without other options.

“Today’s action demonstrates the FDA’s resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain,” FDA Commissioner Margaret A. Hamburg said in a statement.

The agency’s action comes at the behest of Physicians for Responsible Opioid Prescribing, a New York-based advocacy group. But the FDA refused to grant the group’s request to set a maximum daily dose for such drugs, as well as a maximum duration of 90 days for use in treating pain.

The FDA also declined to approve the group’s request to take action on all opioid analgesics, including immediate-release drugs such as Vicodin and Percocet.

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