The U.S. Food and Drug Administration (FDA) approved the re-introduction of alosetron hydrochloride (Lotronex) under restricted conditions of use.
According to the manufacturer, alosetron will be indicated specifically for use in women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have failed to respond to conventional therapy, whose IBS symptoms are chronic, and who have had other gastrointestinal medical conditions that could explain their symptoms ruled out. Symptoms that make diarrhea-predominant IBS severe are frequent and serious abdominal pain, fecal incontinence or the uncontrolled urge to have a bowel movement, or curtailment of daily activities because of IBS.
Serious gastrointestinal events, specifically ischemic colitis and complications of constipation, have been reported in association with the use of alosetron. These events have resulted in hospitalization, blood transfusion, surgery, and some fatalities. In clinical trials, about three women in 1,000 developed ischemic colitis over six months.
The manufacturer is finalizing details of how the risk management plan, which must be approved by the FDA, will be implemented. The risk management plan will include updated warnings in product labeling, a medication guide for patients that explains what to do if they get constipated or have signs of ischemic colitis, a lower starting dose than previously approved, a prescribing program for physicians to be enrolled into based on self-attestation of qualifications and acceptance of certain responsibilities in prescribing the medicine, an agreement for patients to sign attesting that they are informed about risks and benefits of therapy, and directions to prescribers for active follow-up and management of patients.
COPYRIGHT 2002 American Academy of Family Physicians
COPYRIGHT 2002 Gale Group