May 3, 2016 — The FDA is updating the label on Abilify to include stronger warnings about impulse-control disorders after receiving reports of patients who experienced uncontrollable urges to gamble, eat, shop, and have sex.
In a Safety Communication, the FDA said it had received 184 reports of the side effect since Abilify was approved in November 2002.
In the majority of cases, patients who had no history of impulse-control problems started experiencing uncontrollable urges after taking Abilify. These urges went away after stopping Abilify or decreasing the dose.
The FDA said the label on Abilify currently includes warnings about compulsive gambling, but it does not adequately warn about other side effects. The following risks will be added to the label:
- Pathological gambling
- Binge eating
- Spending or shopping excessively
According to the FDA, anyone on Abilify could experience compulsive syndromes. Therefore, doctors should warn patients and ask them about any new or uncontrollable urges.
Patients should also be closely monitored if they have risk-factors, such as a personal or family history of obsessive-compulsive disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors.
The manufacturer of Abilify, Bristol-Myers Squibb, is facing a growing number of lawsuits from people who say they were not adequately warned about the risk.
Evidence linking Abilify and impulse disorders has been growing for years. In 2009, a study by researchers at the Mayo Clinic reported 11 cases of gambling addiction, including one 52 year-old man who lost $100,000 in casinos.
In October 2014, JAMA Internal Medicine published a study in which researchers identified over 700 reports of impulse-control disorders associated with dopamine-receptor agonists. They recommended a “Black Box” warning on Abilify.