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FDA warns about compulsive, uncontrollable urges associated with aripiprazole
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The FDA has added new warnings to aripiprazole drug labels regarding compulsive or uncontrollable urges to gamble, binge eat, shop and have sex associated with use of the antipsychotic.
Uncontrollable urges were reported to stop after discontinuing the medication or reducing dosage, according to an FDA press release.
The agency warned that although these urges are rare, they could result in harm to patients and others if not identified.
Currently, pathological gambling is listed as a reported side effect in aripiprazole drug labels, but the description does not entirely explain the nature of risk for impulse.
The FDA recommends health care professionals alert patients and caregivers of this risk for uncontrollable urges, ask patients about new or increasing urges and closely monitor new or worsening uncontrollable urges in patients at higher risk for impulse-control problems. These include individuals with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse or other addictive behaviors.
Health care professionals should consider reducing dosage or stopping the medication if urges develop.
For more information:
To read the MedWatch safety alert, visit http://www.fda.gov/Safety/MedWatch.