In a new Invokana injury lawsuit, a Louisiana man says Janssen Pharmaceuticals and Johnson & Johnson should have provided better side effect warnings.

Plaintiff Kenneth M. says he started taking Invokana after his doctor prescribed it for him in June 2015.

He alleges that while he took this drug, he developed kidney disease and ketoacidosis, a condition in which blood acidity becomes dangerously high.

His complications were severe enough to require several days’ worth of hospitalization.

Invokana is a type of drug known as an SGLT2 inhibitor. Drugs in this class are used to treat the high blood sugar levels associated with type-2 diabetes.

Invokana is relatively new to the market for type-2 diabetes drugs, having been first approved by the FDA in 2013.

Kenneth now attributes the complications he suffered to the Invokana he took. Were it not for the defendants’ inadequate safety studies and publication of information about the risks of Invokana side effects, he says, his complications could have been avoided.

His Invokana injury lawsuit names as defendants Janssen Pharmaceuticals, its parent company Johnson & Johnson Co., Mitsubishi Tanabe Pharma Corp., and their associated companies.

All defendants named are allegedly involved in the development, manufacture or marketing of Invokana.

Invokana Injury Lawsuit Says Warnings Were Inadequate

According to Kenneth’s Invokana injury lawsuit, the defendants are well aware of clinical studies, adverse event reports, and case reports in which patients taking Invokana suffered from ketoacidosis.

Analysis of adverse event reports show ketoacidosis was reported more frequently in association with Invokana treatment than with other type-2 diabetes drugs, he alleges.

Ketoacidosis is a dangerous medical condition and is considered a medical emergency.

The Invokana injury lawsuit says ketoacidosis can lead to complications including “cerebral edema, pulmonary edema, cerebrovascular accident, myocardial infarction, nonspecific myocardial injury, severe dehydration, and coma.”

Aggravating the risk is the fact that ketoacidosis related to Invokana treatment does not co-occur with the high levels of blood sugar that doctors are accustomed to seeing in cases of diabetic ketoacidosis.

This lack of elevation in blood sugar can lead a treating physician to misdiagnose the condition, delaying proper treatment.

Kenneth says defendants did not include a ketoacidosis warning on Invokana’s label until the FDA required them to do so in December 2015.

The label still does not offer any warning about other Invokana side effects like kidney injury and bone fractures, he says.

Defendants didn’t just neglect to warn patients and doctors about the risks associated with Invokana, Kenneth claims.

He says defendants actively “withheld material information from the FDA and misrepresented material information regarding the risks and benefits of Invokana in its communications with the FDA.”

“Defendants misrepresented that Invokana is a safe and effective treatment for type 2 diabetes mellitus when in fact the drug causes serious medical problems,” the Invokana injury lawsuit says.

Kenneth accuses the defendants of failing to notify the FDA of reports of adverse Invokana side effects like diabetic ketoacidosis.

He says the companies also failed to properly handle information from clinical trials and post-marketing trials.

The Invokana Injury Lawsuit is Case No. 3:16-cv-07591, in the U.S. District Court for the District of New Jersey.