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US bill would force FDA to withdraw approval of new pain drug Zohydro

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g2195 (Published 17 March 2014) Cite this as: BMJ 2014;348:g2195
  1. Mike McCarthy
  1. 1Seattle

Joe Manchin, a Democrat senator from West Virginia, introduced a bill on Thursday 13 March that would force the US Food and Drug Administration to withdraw its approval of the controversial opioid pain drug Zohydro ER.

The FDA’s decision to approve the drug—a high dose, long acting formulation of hydrocodone bitartrate—has been sharply criticized by addiction experts and law enforcement officials, who warned that its approval would lead to a sharp rise in drug addiction and deaths from overdose.1 …

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