Table 5.

Postmarketing Reports of Ischemic Colitis and Complications of Constipation Associated with Alosetron: Reported and Adjudicated Incidence Rates

	Before June 2002 (before reintroduction/prior to the risk management program)*	November 2002-December 2011 (reintroduction under the risk management program)
Number of Prescriptions	586,000	341,784
Patient-Years of Alosetron Exposure†	48,829	28,084
Ischemic Colitis‡
Reported Incidence Rate (pre-adjudication)	1.70	1.53
Adjudicated Incidence Rate (probable/possible)	0.96	1.03
Complications of Constipation‡
Reported Incidence Rate (pre-adjudication)	2.00	0.93
Adjudicated Incidence Rate	0.59	0.25

^*Safety database of adverse events reported as of February 18, 2002 reported by Chang L et al. Am J Gastroenterol. 2006;101(5):1069-1079.⁶

^†Each prescription is considered to represent 30 days of alosetron use.

^‡Per 1,000 patient-years exposure.

Adapted from Tong K et al. Therap Adv Gastroenterol. 2013;6(5):344-357.⁸