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DEA backs tighter labeling for opioids

NEWS IN BRIEF — Posted April 8, 2013

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The Drug Enforcement Administration said it supports a petition filed by a group of 37 physicians that asks the Food and Drug Administration to change the indication for instant-release and extended-release opioids.

The petition, filed in July 2012 by Public Citizen and the New York-based advocacy group Physicians for Responsible Opioid Prescribing, says the FDA should change the labeling so the drugs are no longer approved for patients with moderate noncancer pain. The agency also should limit the maximum daily dose to the morphine equivalent of 100 mg and limit daily use to 90 days for patients with noncancer pain, the petition said (link).

“The clinical use of opioid analgesics must be accompanied by appropriate measures to minimize the adverse health impact associated with the diversion and abuse of these products,” wrote Joseph T. Rannazzisi, deputy assistant administrator in the DEA’s Office of Diversion Control. “The DEA hopes that FDA will implement suitable measures, such as labeling revisions, to help mitigate the adverse impact on the public health resulting from abuse of these products.”

The FDA has not yet reached a decision on the matter, which it said in January “raises significant issues requiring extensive review and analysis by agency officials.” Public hearings were held in February. The FDA also is considering whether to change the scheduling of hydrocodone from schedule III to schedule II, which would bar refills and require a separate written prescription by a physician.

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