Thursday, June 26, 2008

Paxil: FDA In the Dark About Drug's Problems

The WSJ's Alicia Mundy has a report on how lawsuits over GlaxoSmithKline’s handling of information about the suicide risk from Paxil reveal documents "that say a lot about why the FDA often seems to be in the dark when problems with drugs" start showing up post approval. Source.

What is disturbing about the report: In the papers produced in the litigation was an exchange between lawyers suing Glaxo over Paxil and attorneys defending the company. "The upshot: FDA may not even have known all the information to ask for about Paxil. "

More at the link above. The real upshot? Once again there is another report about the FDA being left in the dark. Wow, what a surprise.