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Bristol-Myers Squibb and AstraZeneca withheld information about the risk that their new-generation diabetes drug Farxiga may cause diabetic ketoacidosis, according to allegations raised in a product liability lawsuit recently filed by a California woman who was hospitalized due to the condition, which involves the buildup of acids in the bloodstream.
In a complaint (PDF) filed in the U.S. District Court for the Eastern District of California on June 27, Betty Barker and her husband indicate that the drug makers failed to adequately warn diabetes patients and the medical community about the potential side effects of Farxiga.
Barker began taking Farxiga in March 2015, and indicates that a few months later, in July 2015, she developed diabetic ketoacidosis and dehydration, which caused her to suffer severe and permanent physical injuries. It was not until months later, in December 2015, that the drug makers added diabetic ketoacidosis warnings to Farxiga, providing information for the first time about the importance of seeking immediate medical attention if symptoms develop.
Farxiga (dapagliflozin) was the second member of a controversial new class of diabetes medications approved in the U.S., known as s sodium glucose cotransporter-2 (SGLT-2) inhibitors, which work differently than most diabetes treatments by impacting some of the normal function of the kidney. However, as more diabetics have been switched to Farxiga and other SGLT-2 inhibitors, such as Invokana and Jardiance, a number of serious side effects and health risks have emerged.
“Since Farxiga’s release, the FDA has received a significant number of reports of diabetic ketoacidosis among users of these drugs,” according to the complaint. “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. Despite Defendants’ knowledge of the increased risk of severe injury among users of Farxiga, they did not warn patients, but instead continued to defend Farxiga, mislead physicians and the public, and minimize unfavorable findings.”
In addition to the December 2015 warning update, the FDA also required additional label changes about the potential side effects of Farxiga in June 2016, announcing that SGLT-2 inhibitors may increase the risk of kidney damage. The warning came after more than 100 adverse event reports involving individuals who suffered acute kidney injury while taking Farxiga, Invokana or another SGLT-2 inhibitor.
Barker maintains that her injuries could have been prevented had the manufacturers adequately researched their new-generation diabetes drug and provided accurate warnings, as she indicates that she would not have used Farxiga to treat her diabetes.
The complaint raises allegations similar to those presented in dozens of other product liability lawsuits over Farxiga filed in recent months. Given the similar questions of fact and law raised in claims brought throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation established consolidated pretrial proceedings in April, centralizing all Farxiga cases before U.S. District Judge Lorna G. Schofield in New York City, to reduce duplicative discovery into common issues in the claims, avoid conflicting pretrial rulings from different courts and to serve the convenience of the parties, witnesses and the judicial system.
Hundreds of similar Invokana lawsuits have also been filed against the makers of this competing SGLT2 inhibitor diabetes treatment, which was the first to reach the market and is the most widely used. Those cases are consolidated as part of a separate multidistrict litigation (MDL) in the federal court system, which are centralized in the District of New Jersey.