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Fentanyl REMS May Need Better Surveillance Methods Before Possible Modifications

 
• By Michael Cipriano

Sponsors currently use sources such as spontaneous adverse event reports to assess whether REMS for immediate-release fentanyl products is achieving its purpose, although such methods are limited in their ability to portray a clear picture.

Risk Dial

The US FDA's Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee will convene Aug. 3 to examine additional ways to collect a series of data related to the use of transmucosal immediate-release fentanyl (TIRF) products, as the agency mulls whether the existing risk evaluation and mitigation strategy (REMS) for such medications should be modified.

Approved in December 2011, the TIRF REMS was designed to mitigate the risk of misuse, abuse, addiction and overdose of TIRF medications. The REMS undergone a series of different changes...

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