Reactions 821 - 30 Sep 2000

US Public Citizen group wants‘Lotronex’ banned

The US FDA has received a petition from the USconsumer group Public Citizen calling for a ban ofalosetron [‘Lotronex’; Glaxo Wellcome], according to areport in Marketletter. The petition was prompted byreports linking the drug with serious adverse eventsincluding constipation and ischaemic colitis.

The FDA has recently strengthened warnings onalosetron labelling.* However, the agency believes thatthe benefits of alosetron outweigh any risks in thetreatment of diarrhoea-predominant irritable bowelsyndrome. As of 1 June this year, the FDA had received 7reports of serious complications associated withconstipation and 8 reports of ischaemic colitis inalosetron-treated patients. Of these patients, 10required hospitalisation, 2 underwent surgery and 4underwent endoscopic procedures.

However, Public Citizen is aware of a total of 26 casesof ischaemic colitis associated with alosetron: 7 casesfrom clinical trials and 19 cases since marketing of thedrug. 20 of these patients required hospitalisation. Thegroup notes that a further 10 possible cases of ischaemiccolitis have been reported to the FDA. In addition totheir concerns over these adverse effects of alosetron,Public Citizen says that alosetron has only limitedefficacy. The group considers that ‘there is no way tojustify using a minimally-effective drug that is onlypalliative for a non-life-threatening condition and, in theprocess, putting women at risk of ischemic colitis, whichcan be life-threatening.’* See Reactions 817: 2, 2 Sep 2000; 800839221

Consumer group demands Lotronex ban. Marketletter : 20, 11 Sep2000 800839460

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Reactions 30 Sep 2000 No. 8210114-9954/10/0821-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved