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Vraylar Approved for Schizophrenia, Bipolar Disorder

Last Updated: September 18, 2015.

Label warns against use by certain elderly.

FRIDAY, Sept. 18, 2015 (HealthDay News) -- Vraylar (cariprazine) has been approved by the U.S. Food and Drug Administration to treat two forms of mental illness among adults, schizophrenia and bipolar disorder.

Schizophrenia is a chronic, severe disorder affecting some 1 percent of people in the United States. Symptoms, which typically begin in adults under age 30, commonly include hearing voices or seeing images that aren't real. Warning signs also may include believing other people are reading their minds or controlling their thoughts, suspicion and withdrawal, the agency said in a news release.

Bipolar disorder, sometimes called manic-depression, commonly includes symptoms such as alternating periods of depression and mania, or "highs," characterized by irritability, restlessness, talking quickly, impulsive behavior and decreased need for sleep, the FDA said.

The drug -- a capsule taken once a day -- was clinically evaluated for both disorders in separate clinical trials, each involving more than 1,000 participants.

As with other antipsychotic drugs prescribed to treat schizophrenia and bipolar disorder, Vraylar's label will include a boxed warning of increased risk of death if the drug is used by elderly people with dementia-related psychosis.

Vraylar's most common side effects include tremor, slurred speech, involuntary muscle movement, indigestion, vomiting, drowsiness and restlessness.

The drug is produced by Jersey City, N.J.-based Forest Laboratories, and is distributed by Parsippany, N.J.-based Actavis Pharma.

More information

Learn more from the FDA.

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