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Invokana Lawsuits: Health Authorities Strengthen Warnings

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Ottawa, ONAs Invokana lawsuits are being filed alleging patients were not properly warned about the dangers of using the medication, health authorities in various countries have moved to strengthen the warnings attached to the diabetes medication. Both Canada and the United States have moved to increase the Invokana warnings, while patients on both sides of the border have filed lawsuits against the maker of Invokana.

Invokana (known generically as canagliflozin) is an SGLT2 inhibitor, used as a diabetes medication. Since it was approved for the market, it has faced increased warnings concerning the link to ketoacidosis, a condition in which patients produce high levels of ketones. Patients with high levels of ketones may experience difficulty breathing, abdominal pain, and fatigue, and may require hospitalization to regulate the chemical balance.

On May 16, 2016, Health Canada issued a summary safety review of Invokana and other SGLT2 inhibitors. Its review found that the use of SGLT2 inhibitors "may increase the risk of experiencing diabetic ketoacidosis," based on five Canadian reports of diabetic ketoacidosis in patients using Invokana. The health agency noted that worldwide, a total of 419 cases of ketoacidosis were reported in patients taking any of the SGLT2 inhibitors.

When Health Canada issued its safety review, it stated that the benefits of the drugs still outweighed the risk, but required drug manufacturers to update their warnings to note the possibility of ketoacidosis.

Then, in June 2016, the US Food and Drug Administration (FDA) strengthened the warning about Invokana to include the risk of acute kidney injury. That warning was issued after reports of 101 confirmable cases of acute kidney injury linked to canagliflozin and dapagliflozin (Farxiga) between March 2013 and October 2015. The FDA noted that in approximately half the cases of acute kidney injury, the injury occurred within one month of starting the SGLT2 inhibitor. Most patients improved after discontinuing medication.

Lawsuits have been filed in both the United States and Canada, alleging patients suffered serious side effects and were not warned about the risks of using Invokana. One lawsuit was filed in Ontario, Canada, on behalf of Rossalba Joudry, who says she used Invokana for eight months but stopped after learning about a US class action lawsuit concerning kidney failure. Joudry - who alleges she developed kidney failure as a result of using Invokana - seeks more than $1 billion on behalf of patients allegedly injured through use of the drug.

A lawsuit has also been filed in the US by Jennifer Anzo against Janssen Research & Development. That lawsuit is case number 2:15-at-01102.

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