US Pharm. 2013;38(10):6.
Bethesda, MD—The FDA has announced safety labeling changes and postmarket study requirements for extended-release (ER) and long-acting (LA) opioid analgesics. The updated indication states that ER/LA opioids are indicated for the management of pain severe enough to require daily, long-term treatment for which alternative therapies are inadequate. It further clarifies that they are not indicated for as-needed pain relief. The FDA is also requiring drug manufacturers to conduct further studies and clinical trials. The goals of these postmarket requirements are to further assess the known serious risks of misuse, abuse, addiction, overdose, and death. Once the safety labeling changes are finalized, modifications will also be made to the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS).
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