Other safety alerts
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| The United Kingdom: Aripiprazole (Abilify and generic brands): risk of pathological gambling |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that healthcare professionals prescribing aripiprazole are reminded to be alert to the risk of addictive gambling and other impulse control disorders.
Aripiprazole belongs to a class of medicines called antipsychotics. 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. 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 reminds healthcare professionals and patients of these risks.
From 30 Jun 2009 to 28 Aug 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. 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.
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 United Kingdom 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/aripiprazole-abilify-and-generic-brands-risk-of-pathological-gambling
In Hong Kong, there are 33 registered pharmaceutical products containing aripiprazole. All products are prescription-only medicines. So far, the Department of Health (DH) has received one case of adverse drug reaction related to aripiprazole, but this case was not related to pathological gambling.
Related news was previously issued by Health Canada and the United States Food and Drug Administration, and was posted on the Drug Office website on 3 Nov 2015 and 4 May 2016. Letters to inform local healthcare professionals were issued by the DH on 3 Nov 2015. In Dec 2016, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the product information of locally registered aripiprazole-containing products should include safety information on the risk of pathological gambling and other compulsive behaviours. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Tuesday, Dec 19, 2023
Issued at HKT 15:30
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