June 11, 2002 Despite being linked to at least 4 deaths and nearly 200 serious adverse gastrointestinal events after only 8 months on the market, Lotronex (alosetron hydrochloride) is again approved for severe cases of irritable bowel syndrome (IBS).
Although the U.S. Food and Drug Administration (FDA) has imposed dramatic restrictions on its use, some question the wisdom of having manufacturer GlaxoSmithKline (GSK) in charge of the risk management program.
“This is a classic case of the fox guarding the hen house,” Larry Sasich, PharmD, MPH, a pharmacist and research analyst with Public Citizen’s Health Research Group, says in a news release.
“GSK has a huge stake in this drug and wants it to succeed. The company should not be overseeing the patient safety program.”
After FDA approval of Lotronex in February 2000, reports followed of 84 cases of ischemic colitis and 113 cases of serious complications of constipation by March 8, 2002. Of the 84 patients with ischemic colitis, 54 required hospitalization, 2 received blood transfusions, 11 underwent surgery and 2 died. Of the 113 cases of serious complications of constipation, 83 patients required hospitalization, 2 received blood transfusions, 34 underwent surgery and 2 died.
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