Safety of fentanyl REMS questioned at FDA advisors meeting

Two FDA advisory committees met Friday to discuss the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF).

Two FDA advisory committees met Friday to discuss the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF). At the meeting of the FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSARM), questions were raised about whether patients who need the powerful drugs can obtain them and also whether they are being prescribed to individuals for whom they are not indicated. "I know the FDA thinks the REMS is working, and I guess that depends on your definition of working," said Lewis Nelson, MD, of Rutgers University in Newark, New Jersey, and AADPAC. "I still think it's yet to be proven that it's working. And I'm not convinced we don't have to actually raise the barrier a little bit," he noted. Additionally, written testimony from G. Caleb Alexander, MD, and Joshua Sharfstein, MD, of Johns Hopkins University in Baltimore, with Freedom of Information Act documents showed FDA had early signs TIRF drugs were going to individuals who did not have cancer or were not opioid-tolerant. "Our preliminary findings indicate that the TIRF REMS program has generated red flags for years," the researchers wrote. "There have been multiple warnings that many providers have been engaged in inappropriate prescribing, placing patients at risk." According to a pharmacy claims study presented at the meeting, only 58% of patients who started a TIRF drug were opioid-tolerant; tolerance was defined by the average daily dose of opioids the patient received in the week prior to a TIRF prescription. However, several of the reports presented Friday had small sample sizes or had insufficient details.