What is the FDA REMS for Extended-Release and Long-Acting Opioids?

Last Revised: 
August 27, 2012

The FDA delivered its Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics to the manufacturers in 2012.  According to the FDA news release the REMS "is designed to ensure that healthcare professionals are trained in how to properly prescribe these medicines and how to instruct their patients about using them safely."  It has two components: a medication guide and elements to assure safe use.
 

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