The Food and Drug Administration Thursday ordered new warnings on prescription bowel cleansers marketed by Salix Pharmaceuticals, a Morrisville company that specializes in gastrointestinal treatments.
Oral sodium phosphate drugs, which are used to clear the bowels before a colonoscopy, have been linked to kidney injury that can be permanent, according to the FDA. The FDA alert includes OsmoPrep and Visicol, two of the about a dozen products Salix markets.
Salix shares fell $1.17, or 14 percent, to close at $7.44 Thursday. The stock is down 37 percent in the past year.
The FDA news came a day after Salix announced that it had bought the rights to an experimental diarrhea treatment for a $5 million licensing fee and future milestone payments.
Napo Pharmaceuticals of South San Francisco developed crofelemer as a treatment for chronic diarrhea in HIV/AIDS patients. Salix plans to finish late-stage testing of crofelemer and seek regulatory approval in 2010. If crofelemer proves successful in testing, it will give Salix another product it can market to gastrointestinal physicians and patients. To see more of The News & Observer, or to subscribe to the newspaper, go to http://www.newsobserver.com. Copyright (c) 2008, The News & Observer, Raleigh, N.C. Distributed by McClatchy-Tribune Information Services. For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.
Copyright (C) 2008, The News & Observer, Raleigh, N.C.