FRIDAY, Aug. 14, 2009 (HealthDay News) -- The drug Saphris (asenapine) has been approved by the U.S. Food and Drug Administration to treat adults with either schizophrenia or bipolar I disorder, the agency said Friday.
Symptoms of schizophrenia may include hearing imagined voices, seeing things that aren't present, and having thoughts that others are going to do you harm. This can lead to behavior including withdrawal, extreme fear, and violence.
People with bipolar I have alternating periods of depression and manic highs. Other symptoms may include restlessness, racing thoughts, and impulsive behavior.
Saphris is among a class of drugs called atypical antipsychotics, all of which must be labeled with the FDA's most serious "black box" warning, the agency said in a news release. The label warns of increased risk of death if the drugs are used by older people with dementia-related psychosis. These drugs aren't approved for this so-called "off-label" use.
Common adverse reactions recorded during clinical testing of Saphris included an inability to sit still (akathisia) and other movement disorders, drowsiness, decreased sensitivity in and around the mouth, and weight gain, the FDA said.
Saphris is produced by New Jersey-based Schering-Plough.
The FDA has additional information about this approval.