Abilify (aripiprazole) is an atypical antipsychotic that was approved by the U.S. Food and Drug Administration (FDA) in 2002 to treat schizophrenia. Over the years, it was approved to treat more conditions, including depression and bipolar disorder. In May, 2016, the FDA issued a safety warning announcing that the drug was associated with impulse-control problems including uncontrollable urges to gamble, have sex and shop.
Updating Warning Labels
Aripiprazole is sold in generic form and under several brand names including Abilify, Abilify Maintena, and Aristada. According to the FDA, the existing information about pathological gambling as a reported side-effect of the drug did not give the full picture of the risks involved. The agency is adding new warnings about other impulse-control problems linked to Abilify use, including compulsive eating, sexual actions, and shopping.
The FDA says those at elevated risk for developing impulse-control problems include patients with a personal or family history of:
- Impulsive personality
- Impulse-control disorder
- Obsessive-compulsive disorder (OCD)
- Bipolar disorder
- Drug abuse
- Other addictive behaviors
In 2007, the U.S. Department of Justice (DOJ) announced that Abilify maker Bristol-Myers Squibb, and a former subsidiary, had agreed to pay more than $515 million to settle allegations including a charge that the pharmaceutical company had marketed Abilify off-label.
Although doctors are allowed to prescribe medications off-label when they believe it will help patients, off-label marketing is an illegal practice. It happens when a drug company markets or pushes a drug for uses other than those approved by the FDA.
If you or someone you love has been harmed by Abilify, please talk to an experienced defective drug attorney right away to learn more about your rights.