New safety notice issued for alosetron hydrochloride (Lotronex)
Clinicians are advised to evaluate patients with signs of ischemic colitis (e.g., rectal bleeding, bloody diarrhea, new or worsening abdominal pain), discontinue the drug immediately if signs of ischemic colitis occur, and counsel patients to discontinue the drug immediately if they develop constipation or symptoms of ischemic colitis.
The FDA is requiring Sebela Pharmaceuticals to issue a safety notice associated with alosetron hydrochloride (Lotronex) and make changes to its Risk Evaluation and Mitigation Strategy (REMS) program.
Regarding the drug's risk of serious gastrointestinal adverse reactions, clinicians are advised to evaluate patients with signs of ischemic colitis (e.g., rectal bleeding, bloody diarrhea, new or worsening abdominal pain); discontinue alosetron hydrochloride immediately if signs of ischemic colitis occur, such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain; and counsel patients to discontinue the drug immediately and contact their prescriber right away if they develop constipation or symptoms of ischemic colitis.
Changes to the REMS program include that prescribers are no longer required to affix prescribing program stickers to written prescriptions for alosetron hydrochloride and pharmacies are no longer required to only dispense the drug for a paper prescription with an affixed prescribing program sticker. Electronic prescriptions are now allowed. Patients are no longer required to complete and submit a Patient Acknowledgment Form. Instead, a Patient Education Sheet is available for the prescriber to discuss with the patient.
Clinicians who prescribe alosetron hydrochloride can access training materials to ensure that the benefits continue to outweigh the risks of ischemic colitis and serious complications of constipation. Training materials and additional information can be obtained by visiting the REMS Web site or by calling 1-844-851-3395.