FDA panel to weigh risk of huge Seroquel growth

Millions of prospective prescriptions hang on an FDA advisory committee's decision this week. If the panel approves AstraZeneca's extended release Seroquel as a treatment for depression and generalized anxiety disorder, the drug will be one step closer to an enormous expansion of its potential market. Now OK'd for bipolar disorder and schizophrenia--which, according to NIMH, affect 8.1 million Americans a year--the antipsychotic could then be marketed to the 14.8 million people with depression and 6.8 million with GAD as well.

That's almost a threefold blooming of Seroquel's approved market. And frankly, the numbers are making FDA staffers a bit nervous. According to documents posted on the agency's website, the advisory panel will need to address concerns that unleashing Seroquel on so many millions would also mean putting those millions at risk of the drug's "known metabolic side effects"--weight gain and diabetes--and its potential to boost the risk of tardive dyskinesia.

FDA reviewers say that Seroquel is effective at treating major depression and GAD. It's the "substantial metabolic risk" and other potential adverse effects that are worrisome. But AstraZeneca CEO David Brennan has said that the drug's efficacy may make the risk of side effects worth it, especially for patients whose depression and anxiety are severe.

- get briefing materials posted on AstraZeneca's site
- see the article from the Associated Press
- read the Wall Street Journal story

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