ADR that result in revision of patient information
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| Canada: Safety information for antipsychotic drug Abilify and risk of certain impulse-control behaviours |
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Health Canada announced that 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.
Information for patients:
• 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 their doctor if they 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 their dose without first consulting their doctor.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../55668a-eng.php
In Hong Kong, there are 10 registered pharmaceutical products containing aripiprazole under the brand names of Abilify (6 oral and 1 injectable products) and Aripiprazole Sandoz (3 oral products). The former 7 products are registered by Otsuka Pharmaceutical (HK) Ltd, while the latter 3 products are registered by Novartis Pharmaceuticals (HK) Limited. All products are prescription-only medicines. So far, the Department of Health has not received any adverse drug reaction case related to aripiprazole. In view of the warnings in the above Health Canada's announcement, letters to inform local healthcare professionals of the warnings will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Tuesday, November 03, 2015
Issued at HKT 13:00
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