Aripiprazole (Abilify and generic brands): risk of pathological gambling

Healthcare professionals prescribing aripiprazole are reminded to be alert to the risk of addictive gambling and other impulse control disorders. Healthcare professionals should advise patients, their families and friends to be alert to these risks.

From:
Medicines and Healthcare products Regulatory Agency
Published
18 December 2023
Therapeutic area:
Psychiatry

Advice for healthcare professionals:

  • there has been an increase in the number of Yellow Card reports of gambling disorder and pathological gambling associated with aripiprazole use; concerns have also been raised about a lack of awareness of this issue
  • the UK reports occurred in patients with and without a prior history of gambling disorder and the majority were reported to resolve upon reduction of dose or stopping treatment with aripiprazole
  • advise patients and their caregivers to be alert to the development of new or increased urges to gamble and other impulse control symptoms, such as excessive eating or spending, or an abnormally high sex drive
  • consider dose reduction or stopping the medication if a patient develops these symptoms
  • awareness of this risk must increase among patients and prescribers, as gambling is recognised as a common risk factor linked to suicide and is included within the suicide prevention in England: 5-year cross sector strategy
  • report suspected adverse drug reactions associated with aripiprazole on a Yellow Card

Advice for healthcare professionals to provide to patients:

  • aripiprazole is a medicine that helps with the management of schizophrenia and bipolar disorder
  • do not stop taking aripiprazole without first discussing this with your doctor
  • before taking aripiprazole, inform your doctor if you have any personal history of excessive gambling behaviour or impulse control disorders
  • tell your doctor if you or your family or friends notice that you are developing urges or cravings to behave in ways that are unusual for you, including behaviours such as addictive gambling, excessive eating or spending, or an abnormally high sex drive

Review of pathological gambling associated with aripiprazole

Aripiprazole belongs to a class of medicines called antipsychotics. Aripiprazole has 3 approved indications: treatment of schizophrenia in adults and adolescents aged over 15 years; short-term treatment of moderate to severe manic episodes in Bipolar I Disorder in adults and adolescents aged 13 years and older; and prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.

The MHRA has received reports from stakeholders raising concerns about a lack of awareness of the association between aripiprazole and the development or worsening of addictive gambling behaviours. Since the beginning of 2023, there has been an increased number of Yellow Card reports for aripiprazole which include gambling, gambling disorder or obsessive-compulsive disorder.

A review of the available evidence was considered by the Neurology, Pain and Psychiatry expert advisory group (NPPEAG) of the Commission on Human Medicines (CHM) . The NPPEAG noted that the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL) for aripiprazole contain information regarding pathological gambling and other impulse control disorders. The SmPC states that impulse control disorders may result in harm to the patient and others if not recognised and advises consideration of dose reduction or stopping the medication if a patient develops increased urges while taking aripiprazole. In reviewing this issue, the NPPEAG recommended that the MHRA remind healthcare professionals and patients of these risks.

UK reports of pathological gambling and gambling disorder with aripiprazole

From 30 June 2009 to 28 August 2023, the MHRA received 69 Yellow Card reports citing aripiprazole as a suspect medicine for side effects of gambling or gambling disorder. Thirty-two of these reports were received in 2023. Fourteen reports were also received describing obsessive-compulsive disorders, or related symptoms, with aripiprazole. Aripiprazole is a frequently prescribed antipsychotic medication and usage has been steadily increasing over the past four years. [footnote 1]It is not possible to determine the frequency of these side effects from the currently available data.

Across the 69 reports of gambling and gambling disorder, most reports concerned people aged 20 to 40 years, although there were reports in patients up to 60 years of age. In many cases the patients had no previous history of gambling behaviour. Eight of the cases described patients who had lost significant sums of money and accrued considerable debts. In the majority of cases, cessation of aripiprazole led to a marked reduction or total loss of impulses to gamble. Several of the cases mention that the patient was not aware of this side effect. Awareness of this risk must increase among patients and prescribers, as gambling is recognised as a common risk factor linked to suicide and is included within the suicide prevention in England: 5-year cross sector strategy.

Report suspected reactions on a Yellow Card

Please continue to report suspected adverse drug reactions to the Yellow Card scheme. Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:

When reporting please provide as much information as possible, including information about batch numbers, medical history, any concomitant medication, onset timing, treatment dates, and product brand name.

Article citation: Drug Safety Update volume 17, issue 5: December 2023: 1.

  1. OpenPrescribing: 4.2.1: Antipsychotic drugs – High-level prescribing trends for Aripiprazole: https://openprescribing.net/chemical/0402010AD/ ↩

Published 18 December 2023
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