FDA Asks AZ to Tighten Seroquel Label; 9,000 Lawsuits Start Trials Next Week

Last Updated Jan 28, 2009 11:14 AM EST

UPDATE: An early victory for AstraZeneca. A Florida judge just dismissed the first two cases on motions for summary judgment. So, er ... never mind! Next week in Orlando federal court the first of 9,000 lawsuits filed against AstraZeneca's antipsychotic Seroquel will was to go to trail. The suits allege that AstraZeneca failed to warn patients that side effects of the drug include significant weight gain and diabetes. There are 15,000 plaintiffs.

Filings in the case are already suggesting that the $4 billion Seroquel empire's edges are crumbling, according to Bloomberg: The FDA has asked AZ to highlight the weight gain side effect on its label. That will likely lead to lower scrip levels.

Here's AZ's response:

Seroquel's label has "always provided accurate and appropriate information and warnings," Tony Jewell, a spokesman for AstraZeneca in Wilmington, Delaware, said in an e-mailed statement. "We continue to work with the FDA to share accurate information with the public as more scientific data becomes available about the medicine."
The market thinks the FDA will win that debate: Bloomberg reports that AZ's American stock declined 83 cents, or 2 percent, to $39.99 in New York Stock Exchange composite trading.

Side note: Did you know that in addition to being an antipsychotic, Seroquel is also being used as a sleeping pill?