Invokana lawsuits involving ketoacidosis and serious kidney injuries continue to mount in U.S. courts. However, one of the most recent cases alleges that patients who use the Type 2 diabetes medication may also be at risk for heart attacks.
The complaint was filed last month in the U.S. District Court, Western District of Kentucky, and appears to be one of the first filings involving Invokana and heart attacks. According to the lawsuit, the plaintiff suffered a myocardial infarction in July 2015, after he had been taking Invokana to treat Type 2 diabetes.
“Defendants misrepresented that Invokana is a safe and effective treatment for type 2 diabetes mellitus when in fact the drug causes serious medical problems which require hospitalization and can lead to life threatening complication, including but not limited to Diabetic Ketoacidosis and its sequelae, Kidney Failure and its sequelae, as well as serious cardiovascular problems,” the lawsuit states.
The plaintiff claims that he would not have used Invokana, or would have been adequately monitored for side effects, had he and his physician had been made aware of the serious risks potentially associated with its use.
Invokana belongs to class of Type 2 diabetes medications called SGLT2 inhibitors, and was the first of this category approved for sale in the U.S. Other SGLT2 inhibitors that have since been cleared by the Food & Drug Administration (FDA) include Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.
Since their introduction, Invokana and other SGLT2 inhibitors have been the subject of several safety alerts. This past December, for example, the FDA announced that the labels for all drugs in this class would be updated to reflect the potential for diabetic ketoacidosis. The same Drug Safety Communication also warned that life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that originate as urinary tract infections had also been reported among patients taking SGLT2 inhibitors.
In May, the FDA reported that it was investigating toe amputations that might be linked to the use of Invokana and Invokamet. A month later, the agency announced that kidney warnings included on the labels for Invokana, Invokamet, Farxiga and Xigduo XR would be strengthened, after those medications had been cited in more than 100 reports of acute renal injury.
In September 2015, the FDA also updated labels for Invokana and Invokamet to include information about a possible increased risk of bone fractures.