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An Invokana lawsuit filed last year in Canada seeks $1 billion in damages against drug maker Janssen Pharmaceuticals. The lawsuit, filed in September 2015 at the Ontario Superior Court of Justice, seeks class-action status, which is expected to be determined within the next six or seven months.

Lawsuit Allegations

The Canadian lawsuit makes several allegations, including that Janssen did not conduct adequate long-term studies on Invokana’s effect on kidney health, and also failed to provide adequate warnings to consumers regarding the medication’s side effects, which include:

  • Kidney failure
  • Ketoacidosis
  • Heart attack
  • Impaired renal function
  • Dehydration
  • Urinary tract infection
  • Kidney stones

The plaintiff claims that after being prescribed Invokana by her doctor in 2014, she learned a few months later about the risks of kidney failure through an American television ad. She underwent testing and was subsequently diagnosed with kidney failure, and alleges that had she known of the risks of Invokana, she would never have considered taking the medication to treat her type 2 diabetes. Numerous lawsuits alleging harm through the use of Invokana have also been filed in the U.S.

FDA Warning Concerning Invokana and Bone Loss

On September 10, 2015, the U.S. Food and Drug Administration (FDA) announced a new warning regarding dangerous side effects associated with Invokana, strengthening a previous warning made by the agency in May 2015. According to the warning, canagliflozin, the active ingredient in Invokana and Ivokamet, may increase the risk of bone fractures and decrease bone mineral density.

Along with the new warning, the FDA revised the Adverse Reactions section of the Invokana and Ivokamet to include a new Warning and Precaution confirming the earlier finding that fractures occur more frequently with canagliflozin than placebo, and fractures may occur as early as 12 weeks after starting the drug.

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