GSK gets OK to return Lotronex to US irritable bowel syndrome market

GlaxoSmithKline has been given the go-ahead by the US Food and DrugAdministration to re-introduce its irritable bowel syndrome drug Lotronex (alosetron), about 18 months after the company voluntarily withdrew the product due to the agency's safety concerns.

Following a number of cases of serious gastrointestinal events in Lotronex-treated individuals, including ischemic colitis, GSK pulled the drug from the market after failing to agree on a risk-management plan that would support its safe use (Marketletter December 4, 2000). However, there is a desperate lack of effective therapies for IBS and patients who had been helped by the therapy have been lobbying for its re-introduction. Earlier this year, Lotronex received the backing of an FDA advisory panel which supported the use of measures to reduce risk, such as limiting supplies of the drug and strict oversight of its use (Marketletter April 29).

Limited use