New Seroquel indications.
The committee did not define when quetiapine might be safely given for MDD. But it voted 4-4, with 1 abstention, that the drug was acceptably safe "in certain circumstances" when used as a monotherapy for MDD.
Panelists were clearer that quetiapine should not be used as a first-line therapy for GAD, voting 6-2, with 1 abstention, against that indication.
The FDA generally follows its advisory committees' advice. It is not clear yet how the agency will address any label change for quetiapine. The drug is already approved in the United States as a monotherapy for acute treatment of bipolar depression and mania, a monotherapy for acute and maintenance treatment of schizophrenia, and as an adjunctive therapy for acute bipolar mania.
The manufacturer, AstraZeneca, said the most frequently reported adverse events included dry mouth, somnolence, sedation, and dizziness. Quetiapine's label already has extensive warnings about tardive dyskinesia, but says that the risk in the MDD and GAD studies was very low--at 0.21% in the longer-term trials.
But the panel members said there were too many open questions about quetiapine, including whether it might increase risk of sudden cardiac death, and voted 9-0 in two separate votes that quetiapine was not safe to use as a monotherapy in either GAD or MDD.
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|Title Annotation:||NEWS FROM THE FDA|
|Publication:||Internal Medicine News|
|Article Type:||Brief article|
|Date:||Jul 1, 2009|
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