Two sides of the FDA

Two Faced

There seem to be two FDAs.

There’s the FDA that wants to step up regulation of dietary supplements. And then there’s the FDA that often seems to be barely concerned when adverse reports of an approved drug start flowing in.

That’s the case with an antidepressant drug called Serzone. A lawsuit attempting to force the FDA to ban the drug has been filed by the consumer group Public Citizen. According to the suit, Serzone has been associated with 39 confirmed cases of severe liver damage, 55 cases of liver failure and 20 deaths.

The FDA’s reaction? An Associated Press report states that the FDA maintains that Serzone-related liver failure is rare and “adequately managed by warning patients.”

All the well-known warnings about ephedra weren’t enough to save the herb from being banned. But the Serzone warnings? They’re adequate.

In 2002 – eight years after Serzone’s initial approval – the FDA required Serzone labels to carry a warning about possible liver damage displayed in a black box. The Public Citizen suit claims that in the months since the black-box warning appeared, there have been more reports of liver failure than there were in the first eight years.

According to an FDA spokesperson, the agency is “reviewing the issue.”

The primary Serzone issue is that it contains a chemical that blocks a liver enzyme required to metabolize drugs. The result: The active ingredients may be delivered to the blood stream at levels so high that some patients have a toxic reaction.

While FDA officials review the matter, we don’t really need an official ban to know what course to take. If you know someone who’s taking this drug, help get the word out that there are other, much safer methods to address depression.
To Your Good Health,

Jenny Thompson
Health Sciences Institute
Source:
“Consumer Group Seeks Ban on Antidepressant” Associated Press, 3/15/04, msnbc.com