FDA Panel Issues Mixed Decision on Quetiapine in Depression and Anxiety
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- ANTIPSYCHOTIC AGENTS
- ANXIETY DISORDERS
- DEPRESSIVE DISORDER, MAJOR
- DRUG REACTION, ADVERSE
- PATIENT SAFETY
- PSYCHIATRY
- QUETIAPINE FUMARATE
- UNITED STATES FOOD AND DRUG ADMINISTRATION
A new formulation of extended-release quetiapine, an atypical antipsychotic medication, should not be approved as a monotherapy for major depressive disorder and generalized anxiety disorder because of serious cardiac and metabolic adverse events associated with use of the drug, according to an advisory panel to the US Food and Drug Administration (FDA). The panel, however, voted in favor of approving more limited use of quetiapine as an adjunctive therapy in treatment-refractory depression.
Federal authorities are considering approval of a new formulation of quetiapine for treating depression. A different formulation of the drug is currently approved as a treatment for schizophrenia and bipolar disorder.
(Credit: Molecule Data Source: DrugBank Accession No. DB01224)
Quetiapine fumarate, sold under the brand name Seroquel (AstraZeneca Pharmaceuticals, Wilmington, Del), is currently approved for the treatment of schizophrenia and acute episodes of mania and depression in patients with bipolar disorder. But the drug's maker is seeking approval for wider use of another formulation of the …
