Invokana Lawsuits Filed over Diabetic Ketoacidosis, Kidney Damage Diagnosis

Johnson & Johnson and its Janssen subsidiary face new product liability lawsuits alleging that side effects of Invokana caused former users of their diabetes drugs to suffer kidney damage and ketoacidosis.

Invokana (canagliflozin) was just introduced in March 2013, as the first member of a new class of diabetes drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. However, as more patients have been switched to the new diabetes treatment, a number of serious health concerns have emerged, leading to questions about whether the drug makers adequately warned about potential Invokana injury risks.

At least two Invokana cases were filed late last month over the new-generation diabetes treatment, which is already one of the top selling drugs for Janssen Pharmaceuticals, generating $278 million in sales during the first quarter of 2015.

One complaint (PDF) was filed by Jennifer Anzo in the U.S. District Court for the Eastern District of California on October 26, indicating that Invokana caused her to develop diabetic ketoacidosis, which is a medical condition associated with a build up of acid in the blood.

Anzo indicates that she was prescribed Invokana for glycemic control, and subsequently developed ketoacidosis complications that resulted in her hospitalization in October 2013, suffering nausea, vomiting, severe abdominal pain, severe dehydration, labored breathing, low blood pressure and tachycardia.

“Defendants were aware that the mechanism of action for Invokana places extraordinary pressure on the kidneys and renal system,” Anzo’s lawsuit claims. “Despite their knowledge of data indicating that Invokana use is causally related to the development of Diabetic Ketoacidosis and kidney failure, Defendants promoted and marketed Invokana as safe and effective for persons such as Plaintiff throughout the United States, including this judicial district. Defendants failed to adequately warn physicians about the risks associated with Invokana and the monitoring required to ensure their patients’ safety.”

A separate complaint (PDF) was filed by Gene Schurman in the U.S. District Court for the Southern District of Illinois on October 23, alleging that after beginning treatment with Invokana he suffered severe kidney damage.

“Defendants knew of the significant risk of kidney damage caused by ingestion of Invokana,” according to allegations raised by Schurman in his complaint. “However, Defendants did not adequately and sufficiently warn consumers, including Plaintiff, or the medical community of the severity of such risks.”

Litigation Over Invokana

The complaints come as a growing number of individuals throughout the U.S. are considering filing similar Invokana lawsuits, claiming that the diabetes drug caused them to be hospitalized due to ketoacidosis or diagnosed with kidney failure.

The momentum for the Invokana litigation has emerged since the FDA issued a drug safety warning in May 2015, indicating that the drug may cause high blood acid levels, leading to a diagnosis of ketoacidosis, ketosis or acidosis, which is not usually seen in patients with type 2 diabetes and is more characteristic of type 1 diabetes.

That same month, the Institute of Safe Medication Practices (ISMP) released a report that independently evaluated adverse event reports submitted to the FDA, identifying potential safety signals involving kidney problems with Invokana and other SGLT2 inhibitors.

The group raised questions about whether the potential Invokana risks may actually outweigh the benefits provided by the diabetes drug.

During the first year Invokana was on the market, ISMP highlighted 457 serious adverse event reports submitted to the FDA involving complications from Invokana. These adverse event reports typically only account for a small portion of the total problems associated with prescription medications on the market.

Many of the reported Invokana problems involved kidney failure, kidney impairment or problems with kidney stones, urinary tract infections, dehydration, hypersensitivity and abnormal weight loss. Looking at reports to the FDA’s adverse event reporting system, the ISMP found that Invokana received more serious adverse event reports than 92% of the other drugs regularly monitored by the group.

Similar claims are also being pursued by individuals who used other SGLT2 inhibitors, such as Invokamet, Farxiga, Jardiance, Xigduo XR and Glyxambi. All of the medications have been aggressively marketed since they hit the market over the past two years, but Invokana remains the most widely used of the class.