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FDA to Seek Advice on Opioid-related REMS

Posted 01 August 2018 | By Zachary Brennan 

FDA to Seek Advice on Opioid-related REMS

The US Food and Drug Administration on Friday will seek the advice of outside experts on the effectiveness of a 2011 Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU) for transmucosal immediate-release fentanyl (TIRF) products and whether changes to the REMS might be necessary.

The public advisory committee meeting is part of FDA’s work to mitigate the risks of misuse, abuse, addiction, overdose and complications related to these opioid analgesic drugs.

The meeting - involving the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee - will discuss the findings from assessments conducted by the TIRF manufacturers, in addition to data about use patterns and adverse events.

“The REMS is intended to make sure that TIRF products are prescribed only to appropriate patients. The REMS also includes measures that are designed to limit use only in opioid-tolerant patients; to avoid inappropriate conversion between TIRF medicines; to reduce accidental exposure; and to educate prescribers, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose,” FDA Commissioner Scott Gottlieb said in a statement Wednesday.

Since the REMS was implemented, he noted that there has been a “significant decline in prescribing of TIRF products and currently they are only prescribed to approximately 5,000 patients nationwide.” 

However, assessments show that approximately 42% of TIRF products may have been prescribed to non-opioid-tolerant patients.

“Understanding the reasons for this, whether these patients are truly opioid-non-tolerant, and the range of outcomes for these patients will be a central focus of our public meeting,” Gottlieb added.

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