David Baxter PhD
Late Founder
F.D.A. Panel Endorses New Use for Seroquel XR
New York Times
April 9, 2009
(REUTERS) -- AstraZeneca?s schizophrenia drug Seroquel XR is safe enough for treating some patients with depression, a federal advisory panel said on Wednesday.
The committee of Food and Drug Administration advisers said the drug appeared safe when added to other medicines to fight depression. The panel ruled that the company had not shown acceptable safety for treating patients with anxiety.
Several panel members stressed that doctors should try other medicines for depression first before deciding to add Seroquel XR.
?I think this represents a second-line therapy,? said one panel member, Dr. Frank Greenway, an endocrinologist at Pennington Biomedical Research Center in Louisiana.
The F.D.A. asked the panel to weigh wider use of the drugs versus known side effects including weight gain and tardive dyskinesia, a movement disorder that causes jerking. A recent study also raised concern about sudden deaths of patients taking atypical antipsychotic drugs including Seroquel.
The panel?s recommendations will be considered by the F.D.A. for a final ruling.
Seroquel is AstraZeneca?s second-best-selling drug with $4.5 billion in 2008 sales. Seroquel XR is an extended release version of the medicine with a longer patent life than the original formula. Winning F.D.A. approval for wider use would allow the company to promote it more widely and expand sales.
New York Times
April 9, 2009
(REUTERS) -- AstraZeneca?s schizophrenia drug Seroquel XR is safe enough for treating some patients with depression, a federal advisory panel said on Wednesday.
The committee of Food and Drug Administration advisers said the drug appeared safe when added to other medicines to fight depression. The panel ruled that the company had not shown acceptable safety for treating patients with anxiety.
Several panel members stressed that doctors should try other medicines for depression first before deciding to add Seroquel XR.
?I think this represents a second-line therapy,? said one panel member, Dr. Frank Greenway, an endocrinologist at Pennington Biomedical Research Center in Louisiana.
The F.D.A. asked the panel to weigh wider use of the drugs versus known side effects including weight gain and tardive dyskinesia, a movement disorder that causes jerking. A recent study also raised concern about sudden deaths of patients taking atypical antipsychotic drugs including Seroquel.
The panel?s recommendations will be considered by the F.D.A. for a final ruling.
Seroquel is AstraZeneca?s second-best-selling drug with $4.5 billion in 2008 sales. Seroquel XR is an extended release version of the medicine with a longer patent life than the original formula. Winning F.D.A. approval for wider use would allow the company to promote it more widely and expand sales.
