A Xigduo ketoacidosis lawsuit has been filed against the drug’s makers Bristol-Myers Squibb Co., Astrazeneca LP, and Astrazeneca Pharmaceuticals LP.

Xigduo XR belongs to a class of drugs called SGLT2 (Sodium Glucose Cotransporter 2) inhibitors. Xigduo XR was FDA-approved in October 2014 to treat type 2 diabetes. The drug lowers blood glucose levels by redirecting excess glucose to be excreted through the kidneys “of a population of consumers already at risk for kidney disease,” says the Xigduo ketoacidosis complaint.

Xigduo Ketoacidosis Gets Attention of the FDA

Plaintiff Jennifer C. began taking Xigduo XR in mid-February 2015. On May 30, 2015, she was admitted to a hospital because of severe Xigduo ketoacidosis and acute kidney injury.

She was transferred to the Intensive Care Unit and stayed in the hospital until June 3, 2015.

In December 2015, the FDA tallied 73 adverse event reports from March 2013 to May 2015 linking SGLT2 inhibitors with ketoacidosis that required hospitalization. The FDA feared more cases existed, but had gone unreported. The FDA ordered the label for Xigduo XR and other SGLT2 inhibitors to include a warning regarding the risk of too much acid buildup in the bloodstream. Patients were instructed to stop taking the drug and to seek immediate medical attention if they exhibited any symptoms of ketoacidosis.

More problems followed. It appeared “SGLT2 inhibitors, and Xigduo XR in particular, also dramatically increase the likelihood of a patient developing kidney failure,” adds the Xigduo ketoacidosis complaint.

Because Xigduo XR expels sugar through the patient’s urine, a buildup of sugar in the tubes leading from the kidneys causes a blockage, contributing to kidney failure.

Water loss and salt loss lead to not only dehydration, but also to volume depletion, which means the kidneys don’t push fluid through the vessels as well as they should. The kidneys work harder, which can lead to kidney failure, necessitating dialysis and, ultimately, a kidney transplant.

According to the Xigduo ketoacidosis lawsuit, Bristol-Myers Squibb and Astrazeneca should have known that Xigduo XR had the potential to cause kidney failure even before the drug was approved by the FDA. Another drug in its class, Invokana, had reported a “nearly three-fold increase (1.7% compared to 0.6%) in acute renal failure for patients taking the higher dose of Invokana compared to those taking a placebo, even in patients whose kidney function was normal.”

The Xigduo ketoacidosis goes on to say, “The development of Plaintiff’s injuries was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Xigduo XR.”

The drug companies’ conduct and the advertising and marketing misrepresentations contributed to Jennifer’s injuries, adds the Xigduo ketoacidosis complaint.

The Xigduo Ketoacidosis Lawsuit is Case No. 1:17-cv-01239-JES-JEH in the U.S. District Court for the Central District of Illinois.