Bristol Myers Squibb and AstraZeneca is facing a new Farxiga lawsuit from a New York woman alleging the type-2 diabetes drug induced permanent kidney damage. The claimant alleges the pharmaceutical giants failed to warn her against potential side effects, including diabetic ketoacidosis.

Plaintiff Donna B. had agreed to taking Farxiga (dapagliflozin) for her type-2 diabetes treatment. Like other patients, Donna was expecting the medication to help reduce her blood sugar levels and maintain a healthy level of insulin. At all times during her prescription, Donna says she had followed all prescription instructions as well as physician advice.

Even with this diligence, Donna says it did not prevent her from developing diabetic ketoacidosis. She was officially diagnosed with the condition when she was hospitalized in July 2015, when she had only began taking the medication in January 2015. Donna is filing this Farxiga lawsuit against the pharmaceutical companies for allegedly knowing of this possibility but failing to warn her.

Overview of Farxiga Complications

Farxiga is a relatively new type-2 diabetes medication to the United States market, earning FDA approval on Jan. 8, 2014. The medication is a part of the SGLT2 (Sodium Glucose Contransporter 2) inhibitor drug class, which work by preventing the body from reabsorbing glucose to maintain healthy blood sugar levels.

The excess sugar is then expelled through urination, after being processed through the kidneys. However, this treatment mechanism may induce diabetic ketoacidosis, as this drug directly interacts with the kidneys and may mess with insulin levels.

Diabetic ketoacidosis occurs when the patient’s blood becomes too acidic, which may occur due to lack of insulin. Without enough insulin, the body may metabolize fat instead of sugar. Even though this is a potentially fatal complications, AstraZeneca and Bristol Myers Squibb allegedly failed to warn the public about ketoacidosis.

According to the FDA’s Adverse Event Reporting System (FAERS), the agency indicated there had been 20 cases of diabetic ketoacidosis submitted between March 2013 and June 6, 2013. Each of these patients had required hospitalization and emergency room visits, reportedly due to ketoacidosis complications.

The FDA recently issued a warning that SGLT2 inhibitors like Farxiga, may induce diabetic ketoacidosis. Donna says she filed this Farxiga lawsuit after discovering the FDA warning and finding that the agency had received a number of injury reports indicating ketoacidosis.

Donna’s Farxiga’s lawsuit raises multiple counts, including negligence and failure to warn. Donna states that she never would have used Farxiga, if she had known the risk of diabetic ketoacidosis.

This Farxiga Lawsuit is Case No. 1:17-cv-03636-UA, in the U.S. District Court for the Southern District of New York.