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Editor's Correspondence
January 14, 2002

Safety Concerns About Alosetron

Author Affiliations

Copyright 2002 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2002

Arch Intern Med. 2002;162(1):100-101. doi:

I wish to draw the attention of the readers of the ARCHIVES to issues relative to the safety of the medication alosetron hydrochloride, which is discussed in the recently published article.1 Several weeks after resubmission of the revised manuscript to the journal and 8 days prior to its final acceptance for publication by the ARCHIVES, the manufacturer of alosetron (Lotronex; Glaxo Wellcome, Research Triangle Park, NC) decided to cease marketing the medication. This decision was taken after consultation with the Food and Drug Administration (FDA) about adverse effects that were attributable to use of the medication. The prevalence of constipation (25% with alosetron and 5% with placebo) and the proportion of patients who withdrew from the clinical trial because of constipation (10%) were clearly reported in the manuscript. There were no cases of ischemic colitis or hospitalizations or surgical procedures related to constipation in the cohort who participated in the clinical trial reported to the journal.

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