A diabetes patient has filed a products liability lawsuit against the manufacturers of the diabetes drug Farxiga, alleging that the defendants concealed knowledge of the risks involved in taking the medication.

The defendants facing the products liability litigation are Bristol-Myers Squibb Co., a pharmaceutical company headquartered in New York City, and AstraZeneca LP.

According to the Farxiga side effects lawsuit, plaintiff Bobbie P. of Mississippi alleges that the defendants “concealed their knowledge of Farxiga’s unreasonably dangerous risks from plaintiffs, other consumers, and the medical community.”

The Farxiga side effects alleged by the plaintiff include permanent and severe injuries, severe diabetic ketoacidosis, and kidney damage. She alleges that as a direct result of taking the diabetes drug, she developed diabetic ketoacidosis and will continue to suffer from lingering harm as a result of ingesting the drug.

Bobbie P. currently seeks an award including punitive damages and any other remedy available that the court may see fit to grant

She says she first started taking Farxiga in April 2014, to treat her type-2 diabetes. A month later, however, on June 8, 2014, she allegedly was diagnosed with diabetic ketoacidosis, metabolic acidosis, and acute renal injury.

She was that day admitted into Baptist Memorial Hospital in Oxford, Mississippi, where she remained hospitalized until June 12, 2014. She stopped taking Farxiga upon discharge from the hospital.

The U.S. Food and Drug Administration approved Farxiga on Jan. 8, 2014 for treatment of type-2 diabetes. It’s part of a newer class of diabetes drugs known as SGLT-2 inhibitors.

The Farxiga side effects lawsuit maintains that since the drug was introduced to the market, the FDA has since received a “significant number of reports of diabetic ketoacidosis among users of these drugs.”

The Farxiga side effects lawsuit further reports that “an analysis of the FDA adverse event database shows that patients taking one of the SGLT2 inhibitors, including Farxiga, are twice as likely to report ketoacidosis and/or severe kidney damage than those taking non-SGLT2 diabetes drugs to treat diabetes.”

Farxiga Side Effects Alleged Knowledge By Defendants

The Farxiga side effects lawsuit states that even before the FDA approved Farxiga, the defendants knew of the potential for Farxiga to cause kidney failure. The plaintiff alleges that the defendants knew of the increased risk involved in taking Farxiga but did not warn users, including physicians and the public, of these risks.

Accordingly, the Farxiga lawsuit contends that defendants knew or should have known that a drug in the same class with “nearly identical mechanisms of action” would cause adverse kidney side effects such as acute renal failure and kidney disease, since the likelihood of developing renal adverse effects nearly triples in patients with roughly normal kidney function.

The plaintiff alleges that had she known of Farxiga side effects that could be involved in taking the diabetes drug, she would have never used Farxiga.

The Farxiga Side Effects Lawsuit is Case No. 1:17-cv-04212, in the U.S. District Court for the Southern District of New York.