Seroquel OK'd for Bipolar Depression
Drug Already FDA Approved for Manic Phases of Bipolar Disorder
Oct. 20, 2006 -- The FDA has approved the antipsychotic drug Seroquel to
treat bipolar depression.
Seroquel was already approved to treat the manic phases of bipolar disorder(formerly called manic-depressive illness). It had also been approved
for the treatment of schizophrenia.
The FDA's action makes Seroquel the first drug to treat both the depressive
and manic phases of bipolar disorder, says Seroquel's maker, AstraZeneca, in a
The new approval applies to bipolar depression, not other forms of
The FDA decision was based on an eight-week study of 1,045 patients with
bipolar depression, the drug company tells WebMD.
Patients were randomly assigned to take Seroquel or a placebo containing no
Those taking Seroquel showed greater improvement in bipolar depression
symptoms, overall quality of life, and satisfaction related to functioning,
The studies tested two doses of Seroquel: 300 milligrams and 600 milligrams
The higher dose showed no added benefits, so the 300 milligram daily dose is
what's recommended, says AstraZeneca.
Seroquel was generally well tolerated in the studies, according to the drug
company. The most common side effects were dry mouth, sedation, sleepiness,
dizziness, and constipation.
The drug is not approved for use in children. Check the labeling for