FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

FDA Announces Initiative to Boost Fentanyl’s Safety

April 5, 2019

FDA Commissioner Scott Gottlieb announced new steps the agency is taking to tighten safety requirements for transmucosal immediate-release fentanyl (TIRF) products.

Gottlieb said the agency is sending notices to manufacturers of TIRF medicines—a class of products indicated to manage breakthrough pain in cancer patients who are routinely taking other opioid pain managements—regarding agency changes to the risk evaluation and mitigation strategy (REMS) for TIRF products. 

“It’s clear more needs to be done to better ensure the safe use of these medicines, mitigate their risks and assure appropriate prescribing,” he said.

One REMS change requires prescribers to record a patient’s opioid tolerance alongside each prescription of a TIRF drug for outpatient use. In addition, TIRF medicines dispensed for outpatient use must now be accompanied by evidence of safe use conditions—including “concurrent documentation of opioid tolerance.”

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