Farxiga Ketoacidosis Side Effects Put Man In Coma, Lawsuit Claims

According to a recent product liability lawsuit filed against Bristol-Myers Squibb and AstraZeneca, the drug makers failed to adequately warn about the risk of diabetic ketoacidosis from Farxiga, which allegedly left an Arizona man in a coma.

The complaint (PDF) was brought by Bruce Shayne in the U.S. District Court for the Southern District of New York on April 14, where centralized pretrial proceedings were recently established for similar cases filed throughout the federal court system.

Earlier this month, the U.S. Judicial Panel on Multidistrict Litigation transferred all Farxiga lawsuits to 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.

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Each of the complaints raise similar allegations that the drug makers knew or should have known that side effects of Farxiga may cause users to suffer diabetic ketoacidosis, kidney failure or other health risks, yet withheld information from consumers and the medical community about their new-generation diabetes drug.

Shayne indicates that he was prescribed Farxiga in October 2014, for treatment of his type 2 diabetes.

“Plaintiff agreed to initiate treatment with Farxiga in an effort to reduce his blood sugar. In doing so, Plaintiff relied on claims made by Defendants that Farxiga was safe and effective for the treatment of diabetes,” the lawsuit states. “Instead, Farxiga can cause severe injuries, including diabetic ketoacidosis with coma.”

Shayne was comatose and hospitalized from April 16, 2015, through April 19, 2015, according to the lawsuit.

Farxiga (dapagliflozin) was the second member of a new class of medications approved in the U.S., known as s sodium glucose cotransporter-2 (SGLT-2) inhibitors, which work differently than most diabetes treatments, impacting 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.

In December 2015, the FDA required new diabetic ketoacidosis warnings for Farxiga and other SGLT-2 inhibitors, indicating that users should stop taking the drug and seek immediate medical attention if they develop symptoms of the medical emergency, which causes a build up of acid levels in the blood.

The FDA issued another safety communication about the potential kidney side effects of Farxiga in June 2016, announcing that label warnings were being added about the risk of kidney damage. The warning came after more than 100 adverse event reports involving individuals who suffered acute kidney injury while taking an SGLT-2 inhibitor.

Shayne’s complaint will be consolidated with other Farxiga cases in the FDA MDL established before Judge Schofield, for coordinated discovery and bellwether trials. However, if Farxiga settlements or another resolution for the litigation is not reached in the MDL, each case would be remanded for separate trials throughout the U.S.

Hundreds of similar Invokana lawsuits have been filed over this competing diabetes treatment, which has been linked to similar risks. Those cases are centralized as part of a separate MDL in the U.S> District Court for the District of New Jersey.


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