Table 6.
Comparison of Characteristics for Confirmed Cases of Ischemic Colitis From Postmarketing Data Before Alosetron Withdrawal* and After Reintroduction
| Before June 2002 (before reintroduction/prior to risk management program) | November 2002-December 2011 (reintroduction under the risk management program) | |
|---|---|---|
| Prescribing time span | 10 months | 109 months |
| Sex | 57 female/1 male | 29 female |
| Median age, years (range) | 55 (25-80) | 55 (22-81) |
| ≥65 years | 23% | 17% |
| Median time to onset, days (range) | 14 (0.5-136) | 114 (3-2920) |
| Presentation | ||
| Abdominal pain | 79% | 90% |
| Hematochezia or bloody diarrhea with abdominal pain | 67% | 72% |
| Concurrent constipation | 24% | 21% |
| Outcomes | ||
| Deaths | 0% | 0% |
| Intestinal surgery | 5.2% | 1.7% |
| Transfusion | 1.7% | 0% |
| Hospitalization | 67% | 48% |
| Resolved or improved | 77.5% | 100% |
| Unresolved | 7% | 0% |
| Unknown | 15.5% | 0% |
*
Data for period before withdrawal reported by Chang L et al. Am J Gastroenterol. 2006; 101 (5): 1069-10796 and Gastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Subcommittee Background Package. April 23, 2002. US Department of Health and Human Services, Food and Drug Administration.9 Adapted from Tong K et al. Therap Adv Gastroenterol. 2013;6(5):344-357.8