FDA Warns Users on New Intestinal Drug Lotronex
WASHINGTON — Five women reportedly died after using a popular new treatment for irritable bowel syndrome that can cause severe intestinal side effects, Food and Drug Administration records show.
FDA officials cautioned that it’s too early to know whether the drug Lotronex was to blame, or whether other illnesses contributed to or caused those deaths. But the agency is investigating Lotronex’s safety, even amid renewed calls Monday for the drug to be banned.
Lotronex is the first new therapy in decades for irritable bowel syndrome, a mysterious disorder that affects up to 15% of Americans. IBS involves chronic or recurrent abdominal pain and related problems.
The FDA has warned women and their doctors that Lotronex can cause serious side effects. The FDA has received 49 reports of one side effect, ischemic colitis, among Lotronex users, including three women who died, the agency said. It also has received 21 reports of severe constipation, including two deaths.
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