Safety information for antipsychotic drug Abilify and risk of certain impulse-control behaviours

Starting date:

November 2, 2015

Posting date:

November 2, 2015

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product label update

Audience:

General Public

Identification number:

RA-55668

• What you should do
• Report health or safety concerns
• Media enquiries
• Public enquiries

Labels for the prescription antipsychotic drugs Abilify and Abilify Maintena (aripiprazole) have been updated to advise of an increased risk of impulsive behaviours of pathological gambling and hypersexuality.

Abilify, a tablet taken by mouth, is authorized to treat a certain type of bipolar disorder (bipolar 1, a serious manic-depressive illness involving extreme manic or mixed episodes) in adults and adolescents aged 13 years and older. It is also authorized to treat schizophrenia and related severe psychotic disorders in patients aged 15 years and older, and Major Depressive Disorder in adults when used in combination with other drugs. Abilify Maintena is an injectable drug administered by health professionals and is used to treat schizophrenia in adults.

The Canadian Product Monograph revisions are the result of a Health Canada safety review that found an increased risk of two types of impulsive behaviours with the use of these drugs: pathological (uncontrollable) gambling, and hypersexuality (uncontrollable and/or inappropriate sexual thoughts, urges or behaviours that are so severe or last so long that they cause distress).

The review identified 18 international cases of pathological gambling and six international cases of hypersexuality in the published scientific literature In most cases, the behaviours ceased or improved when treatment was stopped or when the dose was reduced, suggesting a direct link between the drug and the side effect. The reports involved male and female patients ranging from 19 to 64 years old. Health Canada also received five Canadian reports of pathological gambling and/or hypersexuality, but these contained limited information and therefore no conclusions could be made regarding what role, if any, the drugs may have played.

These drugs are widely prescribed, with millions of prescriptions dispensed worldwide each year. They play an important role in helping patients manage serious psychiatric illness and their benefits as an effective treatment option are considered to outweigh their risks. Prior to the review, Abilify Maintena included information on reports of hypersexuality. The label updates help further clarify what is known about these drugs with respect to these rare risks, and add new warnings.

What you should do

• Patients should watch for unusual impulse-related behaviours and report them to their healthcare professional. This includes an uncontrollable impulse to gamble, unusual sexual thoughts, fantasies, desires or behaviours, or any other uncontrollable behaviours that they find distressing while being treated with Abilify or Abilify Maintena.
• Patients who have had a gambling disorder in the past may be at an increased risk of pathological gambling and should be monitored carefully by their healthcare professional.
• Talk to your doctor if you have any questions or concerns about your treatment with Abilify or Abilify Maintena.
• To work properly, Abilify (tablet form) should be taken every day as prescribed. Do not stop taking Abilify or change your dose without first consulting your doctor.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709