| IBS and IBD In The News | |
Tougher Warnings on Lotronex
Reuters August 25, 2000| Other News | |
US officials are now requiring consumer-friendly information about the possible side effects of Lotronex to be distributed. Warnings on the drug are also being strengthened.
According to the FDA, Lotronex is the first drug to carry an agency-approved medication guide to help patients recognize side effects. The rare side effects include ischemic colitis, a condition that restricts blood flow to the bowel, and severe constipation.
These new warnings are not enough, says the group Public citizen, which is organizing a petition to get Lotronex off the market. Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, says that Lotronex "converts a relatively benign disease into a life-threatening situation".
There have been 11 reports of serious constipation from women taking Lotronex, some have necessitated surgery or hospitalization. 8 cases of ischemic colitis were reported before June 1, and 10 more are confirmed or suspected after June 1.
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