Summary Safety Review - ABILIFY and ABILIFY MAINTENA (aripiprazole) - Evaluating the Risk of Certain Impulse Control Behaviours

November 2, 2015

Product

Abilify and Abilify Maintena (aripiprazole)

Potential Safety Issue

Certain impulse control behaviours

Key Messages

• Abilify (aripiprazole) is a medicine taken by mouth, used to treat:
  • manic-depressive illness (bipolar I disorder) in adults and adolescents of 13 years and older. This condition is characterized by periods of elevated moods (mania) and depression.
  • schizophrenia, a brain disorder affecting the ability to make the distinction between what is or is not real in adults and adolescents of 15 years and older.
  • depression in adults when used in combination with other drugs.
• Abilify Maintena (aripiprazole) is an injectable drug used to treat schizophrenia in adults.
• Health Canada conducted a safety review following product labelling updates in Europe that linked the use of aripiprazole with the risk of uncontrollable gambling (pathological gambling), a type of behaviour where an individual cannot control their urges (impulse control behaviour).
• Health Canada's safety review showed evidence of a link between the use of Abilify and Abilify Maintena and an increased risk of certain impulse control behaviours: pathological gambling and uncontrollable sexual behaviours (hypersexuality). Therefore, Health Canada has updated the Canadian prescribing information for both products. Health Canada has issued an Information Update about these changes.

Overview

A safety review was conducted to evaluate the potential link between Abilify and Abilify Maintena (aripiprazole) and certain behaviours where individuals cannot control their urges (impulse control behaviours): uncontrollable gambling (pathological gambling) and sexual behaviours (hypersexuality).

Use in Canada

• Abilify (aripiprazole) is a medicine used to treat:
  • manic-depressive illness (bipolar I disorder) in adults and adolescents of 13 years and older. This condition is characterized by periods of elevated moods (mania) and depression.
  • schizophrenia, a brain disorder affecting the ability to make the distinction between what is or is not real in adults and adolescents of 15 years and older.
  • depression in adults when used in combination with other drugs.
• Abilify Maintena (aripiprazole) is a medicine used to treat schizophrenia in adults.
• Aripiprazole products are available by prescription as tablets (Abilify) and as injection (Abilify Maintena).
• Abilify was first marketed in September 2009, and Abilify Maintena in March 2014.
• The yearly total number of prescriptions for Abilify is estimated to have increased from 3000 in 2010 to over 1 million in 2013^{Footnote a}.

Safety Review Findings

• At the time of the review, Health Canada had received 5 reports of pathological gambling and/or hypersexuality, suspected of being linked with aripiprazole^{Footnote b}. Upon review of these cases, no conclusions could be made regarding what role, if any, the drug may have played due to limited information.
• Among 14 of the 18 international cases of pathological gambling identified in a review of the scientific and medical literature, the behaviours resolved or improved when the treatment with aripiprazole was stopped or the dosage was reduced. The same was observed in 5 of the 6 cases of hypersexuality linked to aripiprazole that were reported in the literature.
• The European Medicines Agency has included a warning statement for the risk of pathological gambling in the labelling information for Abilify and Abilify Maintena. Hypersexuality has also been listed as a side effect.

Conclusions and Actions

• Health Canada's current review concludes that there is a link between the use of aripiprazole and a possible risk of pathological gambling or hypersexuality.
• After the totality of the evidence was considered, and because of the extensive use of Abilify, Health Canada has updated the Canadian prescribing information for Abilify and Abilify Maintena with the addition of a warning statement for the risk of pathological gambling and the inclusion of hypersexuality as a reported side effect (post-market adverse drug reaction). An Information Update has been issued to inform Canadians about these changes.
• Health Canada will continue to monitor side effect information involving Abilify and Abilify Maintena, as it does for all health products on the Canadian market, to find and study potential harms. Health Canada will take appropriate action if and when any new health risks are identified.

Additional Information

The analysis that was carried out for this safety review took into consideration information from scientific and medical literature, Canadian and international adverse reaction reports as well as what is known about the use of this drug in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.