Reactions 829 - 25 Nov 2000

■ The US Public Citizen group has demanded thatthe US FDA remove alosetron [‘Lotronex’] from themarket, in view of the increasing number of reports ofischaemic colitis in patients receiving this drug forirritable bowel syndrome, Marketletter reports. Whenthe Public Citizen group first filed a petition with theUS FDA calling for a ban of alosetron,* at least26 cases of ischaemic colitis had been reported.However, an additional 28 cases have now beenreported to the FDA and 69% of these cases requiredhospitalisation. Also, there are 10 more cases that are‘highly suspicious’ for ischaemic colitis, bringing thetotal to 20 (including 4 deaths). The FDA is currentlyreviewing the reported adverse effects, and is re-evaluating the risks and benefits, of alosetron.* See Reactions 821: 5, 30 Sep 2000; 800839460

Public group demands lotronex removal. Marketletter 27: 20, 6 Nov2000 800839982

1

Reactions 25 Nov 2000 No. 8290114-9954/10/0829-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved