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On Aug. 3, the U.S. Food and Drug Administration review data from the most recent assessment of the Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU) for transmucosal immediate-release fentanyl (TIRF) products. The FDA will be asking the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the findings from the assessments conducted by manufacturers of these products, as well as additional data about their use patterns and adverse events.
In 2010, the FDA determined that a REMS would be necessary to ensure the benefits of TIRF products outweigh their risks. The TIRF REMS was approved in December 2011 to include all members of the TIRF class. The REMS is intended to make sure that TIRF products are prescribed only to appropriate patients.
TIRF medicines are indicated to manage breakthrough pain in adults with cancer who are routinely taking other opioid pain medicines around-the-clock for pain. The assessments show that approximately 42 percent of TIRF products may have been prescribed to non-opioid-tolerant patients.
FDA is asking the advisory committee to evaluate the reliability of our current trend information, and how we can collect even more accurate data. The TIRF REMS program appears to be functioning as intended to ensure that prescribers and pharmacists receive training on the risks and the safe use of TIRF medicines prior to prescribing or dispensing.
FDA will seek the committee’s feedback on any possible modifications to the TIRF REMS goals and requirements, as well as input on the adequacy of the evaluations conducted in the REMS assessments to determine whether the TIRF REMS goals are being met.
