FDA announces safety labeling changes for opioids to tackle misuse
The US Food and Drug Administration has announced safety labeling changes and post-market study requirements for extended-release and long-acting opioid analgesics.
The new regulations aim to cut the number of deaths per year from opioid dependence. Earlier this year the Center for Disease Control’s Vital Signs report showed that prescription painkiller overdoses killed nearly 48,000 women between 1999 and 2010 ( The Pharma Letter July 3).
The class-wide labeling changes will include important new language to help health care professionals tailor their prescribing decisions based on a patient’s individual needs.
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