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Off-Label Use Of Transmucosal Fentanyl Creates Ethical, Practical Dilemma For US FDA

 
• By Michael Cipriano

Advisory committee panelists divided on whether to modify REMS for TIRF products to reduce their wide-ranging off-label use.

Risk Dial

As the US FDA mulls recommendations from the Drug Safety and Risk Management Advisory Committee the Anesthetic and Analgesic Drug Products Advisory Committee about potential modifications for the risk evaluation and mitigation strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products, the agency will have a moral and ethical dilemma on its hands when considering off-label use of these medications.

Panelists were presented with a series of data at an Aug. 3 meeting showing that TIRF products are used in non-cancer patients a majority of the time, despite their indications...

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