FDA has approved the first generic versions of Abilify (aripiprazole) for the treatment of schizophrenia and bipolar disorder.
Four generic manufacturers (Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals, and Torrent Pharmaceuticals) received the go-ahead April 28 to market their generic medicines for patients suffering with these mental disorders.
Aripiprazole, an atypical antipsychotic, is used to control the symptoms of schizophrenia and bipolar disorder, which include impaired perceptions of reality, alternating feelings of depression and irritability, racing thoughts, impulsive behavior, decreased ability to sleep, and possibly hearing voices.
The medication carries a box warning to alert healthcare professionals about the increased risk of death for off-label use of the drug in the elderly who have dementia and psychosis. Aripiprazole and other atypical antipsychotics are contraindicated in this patient population.
In addition, the box warning for aripiprazole warns about the risk of suicidal thinking and behavior in children, teenagers, and young adults. The drug must be dispensed with the Medication Guide, which includes the use and risks associated with aripiprazole.
The most common side effects from clinical trial data of aripiprazole include nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.