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FDA to tighten labeling on long acting opioids

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f5581 (Published 12 September 2013) Cite this as: BMJ 2013;347:f5581
  1. Michael McCarthy
  1. 1Seattle

The US Food and Drug Administration announced on Tuesday 10 September that it would move to change the labeling on extended release, long acting opioids in an effort to reduce the harms associated with these drugs.

Current labeling states that these long acting opioids are indicated “for the relief of moderate to severe pain in patients requiring continuous, around the clock opioid treatment for an extended period of time.”

Under the proposed changes, the labeling will emphasize the fact that the drugs are indicated for “management of pain severe enough to require daily, around the clock, long term opioid treatment and for which alternative treatment options are inadequate.”

The …

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