FDA Told Anti-Depressant Serzone Tied To Deaths

Oct 31, 2003 | Seattle Times A consumer-watchdog group called on the Food and Drug Administration yesterday to immediately remove the anti-depressant Serzone from the market, citing 20 deaths from liver failure that have occurred since the drug was introduced nine years ago.

The advocacy group Public Citizen told the FDA that the drug has "no advantage" over other drugs used to treat depression and that it should no longer be prescribed.

Manufacturer Bristol-Myers Squibb is withdrawing the drug in Canada and has discontinued sales in Europe, amid concern by regulators over liver damage. Three years ago, the FDA required that a cautionary "black box" label be added to the drug indicating it could cause liver failure. The agency also sent a warning letter to physicians, said Thomas Laughren, an FDA official.

The agency views cases of liver failure among Serzone users as a "rare event," Laughren said, adding that not all patients being treated for depression respond to medication in the same way, and that they benefit from having a range of treatment methods available.