FDA Approves Invokamet XR Despite Side Effect Lawsuits

September 29, 2016 — The FDA has approved Invokamet XR as its manufacturer, Janssen Pharmaceuticals, faces a growing number of lawsuits for downplaying risks associated with canagliflozin.

Invokamet XR is the extended-release version of Invokamet, a medication that combines canagliflozin with metformin. Most of the lawsuits involve Invokana, which only contains canagliflozin.

Invokamet XR is a SGLT2 inhibitor that works by forcing the kidneys to remove more sugar from the body in urine.

Unfortunately, canagliflozin has been linked to a wide range of severe side effects since it hit the market in March 2013. Between May 2015 and June 2016, the FDA issued five safety warnings for the following side effects:

• Diabetic ketoacidosis
• Bone fractures
• Acute kidney injury
• Severe infections (bloodstream and kidney)
• Foot and toe amputations

Janssen Pharmaceuticals is facing dozens of lawsuits nationwide. Lawyers accuse the drug-maker of rushing Invokana to market without adequately testing it for safety, failing to warn about side effects, and continuing to sell an unreasonably dangerous medication.

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