OBJECTIVE: @entity29940 (Lotronex), a potent selective @entity750 (3) receptor antagonist, was approved in February, 2000 in the United States for the treatment of @entity294 -predominant @entity1744 ( @entity1744 ) in @entity1 . Marketing was suspended in November, 2000, after reports of @entity63 and serious complications of @entity1142 . We sought to compare the incidence of @entity63 , hospitalized complications of @entity1142 , and bowel surgery among alosetron users and a cohort of @entity1 with @entity1744 who did not use @entity29940 . METHODS: We sought outcomes of @entity63 , hospitalized complications of @entity1142 , and bowel surgery in 3,631 Lotronex users and 2,480 comparison @entity1744 subjects using diagnoses, procedures, and drugs recorded in the UnitedHealthcare insurance claims database, and validated these by chart review. The initial assessment was to last for 3 yr beginning with the start of alosetron treatment and was to include 10,000 Lotronex users; however, the observation period ended by December 31, 2000, after suspension of marketing. RESULTS: There were 3631 alosetron users among members of UnitedHealthcare from March through December, 2000, and we identified 2480 comparison @entity1744 -only @entity1 ; follow-up time averaged about 5 months in both groups. There were no instances of @entity63 in either cohort. Thirty instances of bowel surgery occurred, giving rates of 10.2/1000 @entity1 -yr in the alosetron cohort and 11.8/1000 @entity1 -yr in the @entity1744 /no alosetron cohort. There were three cases of hospitalized complications of @entity1142 . The incidence rates were essentially the same in alosetron users (1.24/1000 @entity1 -yr) and in @entity1744 @entity1 with no alosetron use (0.92/1000 @entity1 -yr). CONCLUSIONS: Alosetron users did not differ from @entity1744 @entity1 not using alosetron in the incidence of bowel surgery or hospitalized complications of @entity1142 ; there were no cases of @entity63 . The statistical upper limit of @entity63 rates in alosetron users was 2.28/1000 @entity1 -yr. Because of the market withdrawal, the size of the cohort and the duration of follow-up were smaller than originally planned; consequently, the statements about the safety of alosetron were necessarily limited. On June 7, 2002, the Food and Drug Administration approved alosetron for reintroduction in the U.S. market for @entity1 with severe @entity294 -related @entity1744 .

Incidence of @entity63 , hospitalized complications of @entity1142 , and bowel surgery in relation to use of XXXX .

@entity1 :: ('9606', 'Species') :: ['women', 'patients', 'person'] @entity29940 :: ('MESH:C090840', 'Chemical') :: ['alosetron', 'Alosetron hydrochloride'] @entity63 :: ('MESH:D007511', 'Disease') :: ['colonic ischemia'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity750 :: ('MESH:D012701', 'Chemical') :: ['5-hydroxytryptamine'] @entity1142 :: ('MESH:D003248', 'Disease') :: ['constipation'] @entity1744 :: ('MESH:D043183', 'Disease') :: ['irritable bowel syndrome', 'IBS']
@entity29940 :: (MESH:C090840,Chemical) :: ['alosetron hydrochloride']
