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FDA is urged to reverse its approval of new pain drug Zohydro ER

BMJ 2014; 348 doi: (Published 03 March 2014) Cite this as: BMJ 2014;348:g1894
  1. Michael McCarthy
  1. 1Seattle

More than 40 consumer groups, addiction treatment organizations, and healthcare agencies have called on the US Food and Drug Administration to reverse its recent approval of a potent oral opioid drug that they say threatens to worsen a widespread addiction to prescription drugs. Those who wrote to the FDA included the American Society of Addiction Medicine, Physicians for Responsible Opioid Prescribing, and the consumer advocacy group Public Citizen.

The drug, Zohydro ER, is an extended release formulation of hydrocodone bitartrate that was approved last year and is scheduled to go on sale this month.

Critics have said …

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