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US opioid makers need plan to safeguard users-FDA
Feb 10, 09 FDA warnings Medical Product Safety AlertsU.S. makers of opioid painkillers will have to take stronger measures to prevent misuse and abuse of the addictive prescription drugs, the Food and Drug Administration said Monday.
The FDA said it was concerned about rising numbers of overdoses and accidental deaths over the past decade despite steps to safeguard users.
Opioids are a class of powerful, highly addictive narcotics often prescribed to relieve chronic pain.
Johnson & Johnson, King Pharmaceuticals Inc, Endo Pharmaceuticals Holding Inc and privately held Purdue Pharma were among 16 manufacturers of brand name and generic opioids asked to implement extra safety measures.
Twenty-four drugs were specifically mentioned by the FDA, including J&J’s Duragesic patch, Purdue’s Oxycontin, King’s Avinza and Endo’s Opana.
The FDA said it would hold a public meeting on the issue in late spring or early summer, in addition to a March 3 meeting with the manufacturers.
WASHINGTON (Reuters)
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