Posted by Tony C. on June 20, 2004, at 7:43:17
Serzone Side Effect: Rare but Unpredictable Liver Damage
By Daniel DeNoon
WebMD Medical News Reviewed By Brunilda Nazario, MD
on Friday, October 31, 2003Oct. 31, 2003 -- The U.S. won't join Canada in banning Serzone, the FDA says. The antidepressant rarely -- but unpredictably -- causes liver damage and death.
Since its introduction in 1994, 55 patients in the U.S. have had Serzone-related liver failure.In late 2001, the FDA required Bristol-Myers Squibb to put a "black box warning" -- the most extreme possible safety warning -- on all Serzone sold in the U.S. Sales plummeted. This means doctors take the warning seriously, suggests an official statement by Russell Katz, MD, director of the FDA's division of neuropharmacological drug products.
"It also seems that some [doctors] still consider [Serzone] to be the right choice for their patients," Katz says in the statement. "We have reviewed the data recently, and we see no reason to remove it from the market here."The FDA position is that as clinical depression is a very serious condition, doctors should have as many treatment options as possible. It seems likely that some patients helped by Serzone don't get relief from other drugs -- although there is no direct proof this is the case.
poster:Tony C.
thread:358256
URL: http://www.dr-bob.org/babble/20040614/msgs/358256.html