FDA Overhauls Opioid Painkiller Labels, Urging Careful Use

Law360, New York (September 10, 2013, 3:01 PM EDT) -- After years of wrenching debate, the U.S. Food and Drug Administration on Tuesday announced labeling revisions that will recommend doctors prescribe extended-release opioid painkillers, such as Purdue Pharma LP's Oxycontin and Endo Pharmaceuticals' Opana, only to patients with constant pain.

The FDA, which also added a new black box warning related to use during pregnancy and mandated more post-approval study by drugmakers, described its action as representing a compromise between competing calls to preserve access for suffering patients and clamp down strongly to curtail rampant abuse....
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