- A new FDA warning links use of aripiprazole, the active ingredient in Otsuka’s Abilify and Alkermes’ Aristada, with uncontrollable urges to compulsively gamble, binge eat, shop, and have sex.
- Aripiprazole, which went generic last year, is used to treat a range of mental disorders including schizophrenia, bipolar disorder, and Tourette's disorder. It is intended to stabilize mood and decrease the psychotic symptoms associated with the disorders.
- In 2015, roughly 1.6 million patients were prescribed aripiprazole for retail pharmacies, a large pool of patients potentially put at risk.
Currently, the labeling for aripiprazole reports pathological gambling as a side effect, but doesn’t indicate the broader range of potential compulsive behavior related to eating, shopping, and sexual activity. The label will be updated to reflect these risks.
Although occurrence of these extreme behavioral issues is rare, the FDA noted the problems could affect anyone taking the drug. According to data from the FDA’s adverse event reporting system, there have been 184 reported cases of impulse control problems over the 13 years since Abilify was first approved. Most of these had to do with pathological gambling.
As a partial dopamine agonist, aripiprazole exerts its therapeutic effect in part through modulation of dopamine receptors. However, this comes with a risk. Dopmaine is the neurotransmitter associated with pleasure in the brain, so increased amounts can lead to delusions of grandeur, obsessive behavior, lack of self-control, and addiction.
The warning did have a small effect on one of the companies which manufacture the drug. Alkermes stock dropped by around 5% after the warning was released Tuesday but recovered slightly to close down only 2%. Aristada brought in $5.5 million in sales in the first quarter, approximately a tenth of Alkermes' net sales for the period.