US law firm Parker Waichman has filed two lawsuits against Johnson & Johnson (J&J) and Janssen Pharmaceuticals related to their diabetes treatment drugs Invokana, Invokamet and Invokamet XR.

Filed in New Jersey State Court on behalf of two amputees, the complaint claimed that the sodium-glucose co-transporter-2 (SGLT2) inhibitor drugs enhance the risk of toes, feet and leg amputations.

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As per the complaint, both patients began using Invokana in early 2015 and had to undergo below the knee amputations in December.

Approved in the US in March 2013 and in the European Union (EU) in November 2013 for the treatment of type 2 diabetes, Invokana is reported to have had $1.31bn and $1.41bn sales in 2015 and 2016, respectively.

“As per the complaint, both patients began using Invokana in early 2015 and had to undergo below the knee amputations in December.”

In February last year, the European Medicines Agency (EMA) informed regarding potential increased risk of lower limb amputation in type 2 diabetes patients using canagliflozin (Invokana), dapagliflozin (Farxiga) and empagliflozin (Jardiance).

The Food and Drug Administration (FDA) confirmed the increased risk with canagliflozin (Invokana, Invokamet, Invokamet XR) in May last year by issuing a Drug Safety Communication based on new findings from two clinical trials.

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The issued communication is reported to have required warnings to be added to the canagliflozin drug labels, describing the risk.

Parker’s lawsuits allege that J&J and Janssen have concealed and continue to conceal their knowledge that use of Invokana has unreasonably dangerous risks of lower limb amputations.

It was further added that the defective nature of the drug led to additional severe and permanent personal injuries such as kidney failure, diabetic ketoacidosis, stroke and heart attack.

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