Originally published by our sister publication Gastroenterology & Endoscopy News

The FDA has determined Risk Evaluation and Mitigation Strategies for the irritable bowel syndrome drug alosetron, originally marketed as Lotronex (Sebela), are no longer necessary to ensure the benefits outweigh the risk for ischemic colitis or other serious complications of constipation.

While safety risks still exist for women with IBS taking the drug, the elimination of the alosetron REMS programs is supported by data, the agency said. Reporting of alosetron-associated adverse events to the FDA Adverse Event Reporting System has been stable since 2002, with no increase in severe outcomes observed. The new decision follows a previous REMS modification for the drug in 2016 that made prescriber training programs voluntary and removed a prescription sticker requirement. Since then, the FDA has not identified any new data to suggest a change in frequency or severity of ischemic colitis or serious complications of constipation. In addition, the FDA’s analysis of new female users of alosetron within the Sentinel Distributed Database from 2016 to 2020 found the rate of ischemic colitis consistent with the rate listed in the prescribing information.

Of note, since the approval of the drug’s generic version in 2015, the FDA did not observe increases in drug use trends. Overall, there has been a downward trend in the estimated total number of patients receiving prescriptions for all alosetron products, the agency reported. 

The FDA foresees that alosetron prescribing will remain steady, even with the removal of REMS, because there is stable availability of approved therapeutic alternatives to the drug. Surveyed prescribers understand the risks of the drug and the need to counsel patients, the agency reported, and data show surveyed patients understand the actions to take if they experience the risks.

—Joe Morreale

Based on an FDA press release.