The popular diabetes medication Invokana has been under fire for causing a variety of complications, including chronic kidney disease and kidney failure, in patients. Lawsuits alleging that Invokana’s manufacturer, Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, failed to properly warn patients and doctors of the increased risks of chronic kidney disease and kidney failure are quickly taking shape.

Invokana was approved by the FDA in 2013 as a new type of Type 2 diabetes treatment called sodium-glucose co-transporter inhibitors. Since its approval, the Food and Drug Administration has issued several safety warnings to patients and doctors about the increased risk of ketoacidosis, urinary tract infections, and kidney injury. The FDA’s latest warning comes after reports of kidney failure, some of which required hospitalization and dialysis.

However, patients are now reporting additional adverse events after taking Invokana. A couple from Illinois filed a lawsuit against Janssen Pharmaceuticals after the Illinois woman suffered a stroke shortly after she began taking the medication. While some patients might have been aware of minor health risks, should they also be worried about suffering a stroke?

When the medication was approved the FDA required Janssen Pharmaceuticals to conduct five separate post-marketing studies on the cardiovascular safety of the drug. While the post-marketing studies have yet to reveal whether or not the medication increases the likelihood of strokes, the science has indicated that an increased risk of leg and foot amputations in patients taking the medication. This finding prompted the European Medicines Agency to issue a warning to European doctors asking them to stop Invokana treatment in certain patients.

Despite Invokana’s growing list of severe side effects, there has been no recall of the medication to date. However, patients aren’t waiting for the FDA to tell them the medication might be dangerous. Invokana lawsuits from across the country allege the manufacturer failed to warn patients of the various risks associated with the drug. Plaintiffs are eagerly looking to post-marketing trial results to confirm what they already know – Invokana can be very dangerous.