FDA Warning Prompts Invokana Lawsuit Investigation

Dallas, TXIt’s been only two years since Invokana was approved to treat type 2 diabetes, but in that time the US Food and Drug Administration (FDA) has received more than 450 adverse event reports involving Invokana side effects. Now, attorneys are investigating possible Invokana lawsuits, noting that at least one serious side effect is not yet mentioned on the drug’s label.

Dr. Shezad Malik, founder of the Dr. Shezad Malik Law Firm, says the FDA has received at least 457 adverse event reports linked to Invokana, Janssen Pharmaceuticals’s diabetes medication. As a result of those reports, in May 2015 the FDA issued a warning about Invokana, alerting doctors and patients about the risk of a serious condition linked to the medication.

Invokana, which is in a class of drugs known as sodium-glucose cotransporter-2 (SGLT2) drugs, works by causing the patient’s kidneys to excrete extra blood sugar in the blood through urine. It is among the newer diabetes treatments, along with other drugs including Farxiga, Invokamet, Glyzambi, Jardiance, and Xigduo XR.

“The FDA has received reports of kidney damage, kidney stones and frequent bladder infections,” Dr. Malik says. “But the most important side effect that the FDA warned about was diabetic ketoacidosis. It’s a condition rarely seen in type 2 diabetics. In patients with diabetic ketoacidosis, the body starts breaking down secondary sources of fuel - proteins and fats, because of low blood sugar. The incomplete burning of the proteins and fats results in ketone bodies, which are acidic. This process is known as diabetic ketoacidosis.”

Patients who develop diabetic ketoacidosis experience dehydration and can develop a lowered pH (acid) level, which affects electrolytes in the bloodstream. When the FDA issued its warning, it noted that all 20 patients who had diabetic ketoacidosis required hospitalization. Malik says the condition can be potentially fatal.

The FDA warns patients to be aware of the symptoms of diabetic ketoacidosis, including difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. According to Malik, many patients were not aware of the potential for diabetic ketoacidosis because a warning did not appear on the label.

Attorneys are now investigating potential lawsuits on behalf of patients or their loved ones who developed serious diabetic ketoacidosis. Patients who required hospitalization or respiratory support, developed infections or pancreatitis, or who went into a coma after using Invokana might be eligible to join a lawsuit.

Investigations are still in the early stages, so if you or a loved one suffered diabetic ketoacidosis after taking Invokana, it’s not too late to talk to an attorney.