Invokana Kidney and Ketoacidosis Side Effects Caused Severe Damage, Lawsuit Alleges

According to allegations raised in a product liability lawsuit filed last week, side effects of Invokana caused a user of the new-generation diabetes drug to suffer both kidney damage and diabetic ketoacidosis.

The complaint (PDF) was filed by Karen Robertson, and her husband Samuel, in the U.S. District Court for the District of New Jersey on April 13, claiming the makers of the diabetes treatment knew about the increased risk of severe injury among Invokana users, yet failed to warn consumers or the medical community.

Although the medication has only been on the market for three years, the FDA has already required a number of warning label updates and a growing number of consumers are now pursuing similar Invokana injury lawsuits after experiencing severe problems with the drug.

Invokana (canagliflozin) was introduced by Johnson & Johnson and its Janssen Pharmaceuticals subsidiary in March 2013, as the first member of a new class of diabetes drugs, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Amid aggressive marketing by the drug maker following approval, the medication was quickly adopted by the medical community. However, it now appears the drug makers failed to adequately research the medication or warn about potential side effects.

Robertson indicates that she was prescribed Invokana for the treatment of diabetes in October 2015. As a result of the medication, the lawsuit claims she suffered severe kidney damage and diabetic ketoacidosis, which is a medical condition involving a dangerous build up of acid in the blood.

“Despite Defendants’ knowledge of the increased risk of severe injury among Invokana users, Defendants did not warn patients put instead continued to defend Invokana, mislead physicians and the public, and minimize unfavorable findings,” according to the complaint filed against Johnson & Johnson, Janssen and Mitsubishi Tanabe Pharma Corp. “Consumers, including Plaintiff Karen Robertson, who have used Invokana for treatment of diabetes, have several alternative safer products available to treat the conditions.”

Invokana Health Risks

As more users began to use Invokana, the FDA began to receive a large number of adverse event reports involving health risks that were not initially indicated on the warning label for the diabetes drug.

In May 2015, the FDA launched an investigation into the link between Invokana and ketoacidosis after identifying at least 20 reports of individuals being hospitalized due to acid problems with the drug or other members of the SGLT2 inhibitor class of diabetes medications, which also include Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.

The agency ultimately required Johnson & Johnson to add new Invokana warnings about ketoacidosis in December 2015, urging users to stop taking the drug and seek immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.

In September 2015, the FDA required new Invokana bone fracture warnings, indicating that the drug may lead to decreased bone density.

A detailed review conducted by the Institute of Safe Medication Practices (ISMP) of all adverse event reports submitted to the FDA during the first year Invokana was on the market identified a risk of kidney damage with Invokana and other SGLT2 inhibitors, which work in a unique way by impacting the normal function of the kidneys.

ISMP identified at least 457 serious adverse event reports submitted to the FDA involving complications from Invokana or other similar drugs, which would only account for a small portion of the total problems associated with prescription medications on the market, since most drug injuries are never reported.

Many of the reported Invokana kidney problems involved renal 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.

ISMP raised questions about whether the potential risks associated with the medication may outweigh the benefits, leading some questions to be raised about whether an Invokana recall should be issued, or limitations should be placed on who receives the medication.

“Defendants knew of the significant risk of kidney damage and diabetic ketoacidosis caused by ingestion of Invokana. However, Defendants did not adequately and sufficiently warn consumers, including Plaintiff Karen Robertson, or the medical community of the severity of such risks,” according to the complaint filed last week. “To the contrary, Defendants conducted nationwide sales and marketing campaigns to promote the sale of Invokana and willfully deceived Plaintiff Karen Robertson, her healthcare professionals, the medical community, and the general public as to the health risks and consequences of the use of the Invokana.”

Robertson’s Invokana kidney damage and ketoacidosis lawsuit presents claims for defective manufacturing, defective design, failure to warn, breach of warranty, negligence, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment, and fraud, seeking both compensatory and punitive damages.