|
|
Article: FDA Meeting on Lotronex Side Effects Signals New Safety Push.(Glaxo Wellcome's drug therapy for irritable bowel syndrome)(Brief Article)
- Article from:
- Medical Letter on the CDC & FDA
- Article date:
- July 16, 2000
CopyrightCOPYRIGHT 2000 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
2000 JUL 16 - (NewsRx.com) --
Sixteen women suffered serious intestinal side effects - some requiring surgery - after using a treatment for irritable bowel syndrome that has been on the market for only four months, U.S. Food and Drug Administration (FDA) officials said June 27, 2000.
But the unprecedented public debate about the safety of Lotronex, a long-awaited treatment, signals the FDA's concern goes far beyond this one medicine.
Shaken by a spate of drugs banned in part because doctors disregarded or never even read safety warnings, the FDA has begun a new initiative to swiftly counter side effects of newly approved drugs - especially ...