The companies behind a prescription drug that was recently approved to treat symptoms of agitation in Alzheimer’s patients are facing a class-action lawsuit over alleged “harmful side effects” to patients.
The lawsuit relates to the antipsychotic drug Rexulti, which was approved by Health Canada in January for managing agitation associated with dementia due to Alzheimer’s disease in patients with aggressive behaviour that is unresponsive to non-pharmacological approaches.
Rexulti was also previously approved in Canada for the treatment of schizophrenia in adults and as an additional therapy to antidepressants in adults with major depressive disorder (MDD).
The Superior Court of Quebec authorized a national class action earlier this month on behalf of all Canadians who were prescribed and used Rexulti and developed some side effects.
In a news release Thursday, Toronto law firm Rochon Genova LLP said the class action seeks, among other things, damages for both personal injuries and financial loss as well as damages allegedly suffered by family members of individuals taking Rexulti.
The lawsuit alleges that Rexulti can cause compulsive behaviours and impulse control disorders, including compulsive gambling, hypersexuality, compulsive shopping and binge eating.
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It also alleges that the pharmaceutical companies Otsuka Canada Pharmaceutical Inc. and Lundbeck Canada Inc., which co-developed Rexulti, “failed to adequately warn” patients and their doctors of this risk.
Moreover, the pharmaceutical companies allegedly “failed to conduct adequate research and testing in relation to those side effects and conspired to conceal the risks of these harmful side effects from the Class Members,” according to the law firm.
Both Otsuka Canada Pharmaceutical Inc. and Lundbeck Canada Inc. have denied these allegations. The court has yet to rule on the merits of the class action.
Class members include all Canadian residents who were prescribed and used Rexulti starting Feb. 16, 2017, and who developed one or more of the following: compulsive gambling, hypersexuality, binge eating, and compulsive shopping and/or spending.
Those who wish to opt out of this class action have until May 15 to do so by mailing a signed form to the Superior Court of Québec in Montreal.
Rexulti can be taken once daily with or without food.
Some of the side effects of the drug include diarrhea, constipation, weight gain, headache, dizziness, anxiety, sleep-walking, bladder infection and rash, according to Health Canada.
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