A diabetes patient from Texas is suing Janssen Pharmaceuticals in Pennsylvania state court, alleging the company’s drug Invokana caused his ketoacidosis.

Plaintiff Arthur P.’s Invokana lawsuit says he was hospitalized for diabetic ketoacidosis in February 2015, after having taken Invokana for about three months.

He faults Invokana manufacturer Janssen Pharmaceuticals for failing to properly warn about the risk ofInvokana ketoacidosis, despite knowing of “severe” injuries among Invokana patients.

Arthur also says Janssen failed to disclose information about Invokana side effects to the FDA. He accuses the company of withholding and misrepresenting material information about the risks and benefits of Invokana in its communications with pharmaceutical regulators.

Though Arthur now lives in Texas, he filed his Invokana lawsuit in Philadelphia, where he says he took Invokana. His claim is pending in the Court of Common Please for Philadelphia County.

A spokesperson for Janssen said the company disputes Arthur’s Invokana lawsuit and intends to aggressively defend itself against it.

Invokana Side Effects

Invokana, also known by its generic name canagliflozin, has been on the market since first getting FDA approval in 2013. The brand-name drug Invokamet uses the same active ingredient in conjunction with metformin.

Invokana is one of a relatively new class of medications known as SGLT2 inhibitors. These medications are approved solely as treatments for type 2 diabetes, not type 1.

In December 2015, the FDA ordered a change in the labeling for Invokana and other SGLT2 inhibitors. The new label is now required to mention ketoacidosis among possible Invokana side effects.

Ketoacidosis is a dangerous condition in which the blood’s acidity is increased beyond what is normal, due to the presence of chemical bodies known as ketones, the announcement states. Diabetic ketoacidosis can happen when insulin levels are too low to provide the body with enough glucose to meet its energy demand.

The FDA noted that Invokana ketoacidosis is unusual in that it occurs in patients with type 2 diabetes. Diabetic ketoacidosis usually occurs only in patients with type 1 diabetes.

The agency recommended that patients taking these drugs stop taking them immediately and seek medical treatment if they experience any symptoms of ketoacidosis. These symptoms include “nausea, vomiting, abdominal pain, tiredness, and trouble breathing,” the agency said.

This label change followed up on a drug safety communication issued in May 2015, warning about the risk of Invokana ketoacidosis. The agency said a review of its adverse event reporting system revealed 73 cases reported from March 2013 to May 2015 in which patients treating diabetes with an SGLT2 inhibitor suffered ketoacidosis. The announcement says other cases of ketoacidosis likely occurred that were not reported to the FDA.

Each reported case required hospitalization or emergency room treatment, the agency said. In some cases, treatment was delayed because blood sugar levels were lower than those normally expected in cases of diabetic ketoacidosis, the agency said.

Earlier in September 2015, the FDA also required labeling changes warning about other Invokana side effects, including decreased bone density and an increased risk of fracture.

The Invokana Ketoacidosis Lawsuit is Case No.151200653, in the Philadelphia County Court of Common Pleas.