Abilify Linked to Impulse-Control Problems

[Retired]

FDA Warning: Antipsychotic Linked to Impulse-Control Problems
PsychiatryAdvisor.com
May 6, 2016

The Food and Drug Administration (FDA) issued a warning that the use of aripiprazole has been linked to compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex. These impulse-control problems were reported to have ended upon discontinuing the medication or reducing the dose.
Aripiprazole, an atypical antipsychotic, is marketed as brand name Abilify (Otsuka), Abilify Maintena (Otsuka), Aristada (Alkermes), as well as generic products. It is indicated for the treatment of certain psychiatric disorders, including schizophrenia, bipolar disorder, Tourette's, and irritability associated with autistic disorder. It is sometimes used with antidepressants to treat depression.

Currently, pathological gambling is mentioned as a reported adverse event in aripiprazole drug labels but it does not encompass the full nature of the impulse-control risk that the FDA has identified nor does it include the other compulsive behaviors associated with aripiprazole use. The FDA warned that the impulsive behaviors, though rare, may cause harm to the patient or others if not identified. The FDA is requiring the addition of new warnings to include all of these compulsive behaviors in the drug labels and Medication Guides for all aripiprazole drugs.

The FDA Adverse Event Reporting System (FAERS) database and literature searches returned a total of 184 case reports where there was an association between the use of aripiprazole and impulse-control problems. The most common problem was pathological gambling, which was cited in 164 cases.

Other compulsive behaviors included compulsive sexual behaviors (n=9), spending/shopping (n=4), multiple impulse-control problems (n=4), and compulsive eating (n=3). In all of the 167 FAERS cases, patients experienced the new urges only after initiating treatment with aripiprazole but the urges resolved after reducing the dose or discontinuing treatment; none of the patients had concurrent substance abuse disorders, manic symptoms or a history of the said compulsive behaviors. Four of the cases found in medical literature reported a return of compulsive behaviors when aripiprazole was restarted.

Healthcare professionals should inform patients and caregivers about the risk of these impulse-control behaviors when prescribing, and also ask about any new or increasing urges during treatment with aripiprazole. Patients at higher risk for impulse-control problems include those with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors. If such urges arise, clinicians should consider dose reduction or discontinuing the medication.

Reference
Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems. FDA. Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems. Accessed May 6, 2016.

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FDA Warning follows in Post #2

 

[Retired]

Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems
FDA.gov
May 3, 2016

AUDIENCE: Psychiatry, Internal Medicine, Patient

ISSUE: FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.

Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk FDA identified. In addition, FDA has become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions. These compulsive behaviors can affect anyone who is taking the medicine. As a result, FDA is adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.

See the FDA Drug Safety Communication for additional information, including a Data Summary.

BACKGROUND: Aripiprazole is used to treat certain mental disorders, including schizophrenia, bipolar disorder, Tourette’s disorder, and irritability associated with autistic disorder. It may also be used in combination with antidepressants to treat depression. Aripiprazole can decrease hallucinations and other psychotic symptoms such as disorganized thinking. It can stabilize mood, improve depression, and decrease the tics of Tourette’s disorder.

RECOMMENDATION: Health care professionals should make patients and caregivers aware of the risk of these uncontrollable urges when prescribing aripiprazole, and specifically ask patients about any new or increasing urges while they are being treated with aripiprazole. Closely monitor for new or worsening uncontrollable urges in patients at higher risk for impulse-control problems. These include those with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors. Consider reducing the dose or stopping the medicine if such urges develop.

Patients and caregivers should be alert for uncontrollable and excessive urges and behaviors while taking aripiprazole. It is important to talk with a health care professional as soon as possible if you or a family member experiences any of these uncontrollable urges, in order to prevent or limit possible harm. Patients should not suddenly stop taking their aripiprazole medicine without first talking to their health care professional.

 

[amazingmouse]

Abilify is a billion dollar industry and most decent clinicians have known this for years. Leading psychiatrists have spoken on this medication and why it should not be used broadly and without all due considerations. I have read some publications on this medication that were quite controversial. It was often advertised as a magic pill. The power is with the commercial industry.