FDA panel recommends tighter rules for prescribing opioids

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f1012 (Published 14 February 2013)
Cite this as: BMJ 2013;346:f1012

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  1. Michael McCarthy
  1. 1Seattle

An advisory panel of the US Food and Drug Administration has recommended that the FDA reclassify hydrocodone combination products as schedule II drugs, defined as those having a high potential for abuse and severe threat of dependence. These products include the popular combination of hydrocodone and acetaminophen (paracetamol), such under brands such as Vicodin.

The panel, which met on 24-25 January, voted 19 to 10 in favor of rescheduling. Although such recommendations are considered only advisory, the FDA usually follows its advisory panels’ guidance.

Hydrocodone combination products are currently classified as schedule III drugs, recognizing that they pose a “moderate” risk of dependence. But …

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