Aripiprazole (Abilify): reminder on known risk of gambling disorder
The MHRA has reminded healthcare professionals prescribing aripiprazole to be alert to the known risk of patients developing addictive gambling, following a rise in the number of reports received in 2023
Aripiprazole is an important medicine for the treatment of schizophrenia and bipolar disorder. Patients are advised to tell their doctor if they or their family and friends notice they are having unusual urges or cravings that they cannot resist, including behaviours such as addictive gambling, excessive eating or spending, or an abnormally high sex drive.
Patients should continue taking aripiprazole as advised. Stopping aripiprazole without medical advice can be harmful.
In the last 14 years, the MHRA’s Yellow Card scheme received 69 reports of gambling or gambling disorder where aripiprazole was suspected to be the cause. Thirty-two of these reports were received between 1 January and 31 August this year. In March 2023, the MHRA asked gambling clinics to report any suspected cases which may account for some of the rise.
Information on these possible side effects have been included in the Patient Information Leaflet and product information since 2012 (gambling) and 2018 (other impulse control disorders).
Alison Cave, MHRA Chief Safety Officer, said:
The number of reports for suspected gambling and other impulsive behaviours associated with aripiprazole are small in comparison to the frequency with which it is prescribed, but the consequences for any patient developing these conditions can be significant.
Aripiprazole is an effective and acceptably safe drug for many people. We are urging all patients to continue to take it and to speak to your doctor if you have any concerns. Please make sure you tell your doctor before starting the medicine if you have a personal history of excessive gambling or any other impulsive behaviours.
We are highlighting these risks so that you, your family and friends are aware and can flag to your doctor if you are developing urges or cravings that are unusual for you. You should also report them to our Yellow Card scheme.
The UK reports of suspected addictive gambling occurred in patients both with and without a history of problem gambling and most reported that the urges resolved on reducing the dose or stopping treatment with the drug.
Prof Henrietta Bowden-Jones OBE, Director of the National Problem Gambling Clinic, said:
Clinicians prescribing Aripiprazole must commit to consistently alert patients about these potential risks, both during the initial prescription and follow-up reviews. A significant number of patients with gambling disorder seen at the National Problem Gambling Clinic were unaware of the risks as their mental health teams had not alerted them.
Many had not undergone periodic reviews to assess any new symptoms of gambling disorder or other compulsive behaviours that were not present before the prescription started.
As with any medicine, the MHRA keeps the safety and effectiveness of aripiprazole under close review. Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Find out more
Aripiprazole: risk of pathological gambling DSU
Notes to editors
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Aripiprazole is approved for the following indications: a) treatment of schizophrenia in adults and adolescents aged over 15 years; b) treatment of moderate to severe manic episodes in bipolar disorder in adults and adolescents aged 13 years and older; c) prevention of a new manic episode in adults who have experienced predominantly manic episodes and whose manic episodes previously responded to aripiprazole treatment.
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Aripiprazole is part of a class of medicines known as dopamine agonists. The MHRA has published advice for healthcare professionals for other medicines in this class which have similar reported side effects: Dopamine agonists: pathological gambling, increased libido, and hypersexuality - GOV.UK (www.gov.uk).
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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which are published on the MHRA Products website.
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Aripiprazole was prescribed over 1.5 million times between 1 October 2022 and 30 September 2023 - latest data from OpenPrescribing. It is not possible to determine the frequency of these side effects as a proportion of total prescribing from the currently available data.
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For more information on aripiprazole see: Aripiprazole: a medicine to treat mental health conditions - NHS (www.nhs.uk)
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.