Off-Label Use Of Transmucosal Fentanyl Creates Ethical, Practical Dilemma For US FDA
Advisory committee panelists divided on whether to modify REMS for TIRF products to reduce their wide-ranging off-label use.
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In a series of REMS changes, FDA is finally embracing the "R-word" for transmucosal fentanyls that a "provocative" advisory committee member had suggested last year.
CMS and FDA data showed prescriptions jumping while other fentanyl products were coming down.
Some members feel more education has important role in risk management for transmucosal immediate-release fentanyl products, while others think further education will be useless in ensuring the REMS meets its goals.