Health Canada has updated the labels on two widely-prescribed antipsychotic drugs to include warnings about increased risk of “pathological gambling and hypersexuality.”
The updated safety information affects these drugs:
- Abilify, an oral tablet prescribed to treat bipolar 1, a type of bipolar disorder, in adults and adolescents aged 13 and older. The drug is also used to treat schizophrenia and related disorders in patients who are 15 or older.
- Abilify Maintena, an injectable drug used to treat schizophrenia in adults. This drug already included information about hypersexuality, but that has now been updated and clarified.
Health Canada says it has revised the labels on those drugs after a safety review found an increased risk of pathological gambling and hypersexuality with their use. The government agency defines hypersexuality as “uncontrollable and/or inappropriate sexual thoughts, urges or behaviours that are so severe or last so long that they cause distress.”
The Health Canada review found 18 international cases of uncontrollable gambling and six cases of hypersexuality linked to Abilify and Abilify Maintena in published scientific literature. Those cases included both men and women between the ages of 19 to 64.
Health Canada says the two drugs are “widely described, with millions of prescriptions dispensed worldwide each year.”
The agency says the drugs play an important role in managing psychiatric illnesses, but patients who notice unusual “impulse-related” behaviours should report them to their doctors.
