Federal health regulators have warned that an active ingredient found in medication commonly prescribed to treat mental disorders has been linked to compulsive behaviors.
The Food and Drug Administration (FDA) said on May 3 that the antipsychotic drug sold under the generic name aripiprazole and brand names Aristada and Abilify have been associated with compulsive behaviors such as binge eating, gambling, compulsive shopping and sex.
The FDA said the compulsive behaviors cease once users stop using the medications or when the dose is lowered, suggesting a close correlation. The agency noted that while such cases are rare, these can theoretically affect anyone who takes the medication.
Pathological gambling is already indicated on the drug's label as a side effect of the medication, but the FDA said this does not sufficiently convey the scope of what users could experience from using the drug.
Thus, the drug's packaging and patient guides from now on will warn of the other side effects of using the medication, which is used to treat mental disorders such as schizophrenia, bipolar disorder, Tourette's disorder, depression, and irritability associated with autistic disorder.
"These compulsive behaviors can affect anyone who is taking the medicine," the FDA said. "As a result, we are adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products."
Aripiprazole has been commercially available for 13 years, and during this period it has been prescribed to about 1.6 million patients.
The agency has received 184 cases of impulse-control problems albeit it hinted that other instances may have gone unreported. Gambling, which has 164 reported cases, is the most commonly reported problem.
Although the issues appear to go away when the medication is stopped or the dosage is reduced, the FDA said patients need to talk to their doctors first prior to making changes to the dosage themselves.
The agency also wants patients and caregivers to be aware of the possibilities for such behaviors and to talk to a healthcare provider once the patient starts to exhibit such tendencies.
Similarly, the FDA advised doctors to ask patients if they experience uncontrollable urges, particularly those who already have impulse-control problems, such as individuals who have drug or alcohol abuse problems and those with bipolar disorder or obsessive-compulsive disorder.