FDA Panel Split on Possibility of Adverse Effects of Popular Antipsychotic in Treating Depression

[This article posted on April 8, 2009. It is posted within the following categories: Pharma & Devices, via Michael Douglas, MD, MBA.]

This has to be the absolute sanest thing the FDA has done in quite a while: reject a drug (for an indication to treat depression) which appears in the same class as drugs used to treat acute psychosis and chronic schizophrenia (!)

A committee of Food and Drug Administration advisers said Seroquel XR was safe enough for treating some patients with depression but opposed use of the drug for fighting anxiety given the serious side effects.

The panel voted 6-3 that Seroquel XR had acceptable risks if it was added to other medicines to find a workable combination to alleviate depression. Several panel members stressed that doctors should try other treatments for depression first before deciding to add Seroquel XR.

Okay, so the FDA’s stance was not exactly prohibitive on the use of Seroquel to treat depressed mood; it was more conciliatory (almost as if its pharma company requested it)…

The panel split 4-4, with one abstention, when asked if it was safe enough to use Seroquel XR as the only treatment for depression in some cases. Panelists said there were safer medicines that should be tried if only one medicine was going to be used.

Does that mean that physicians **won’t** prescribe it for depression as a first-line? Heck, they already give the stuff for sleep. | LINK

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