Farxiga Ketoacidosis Lawsuit Filed Over Failure to Warn About Risk for Diabetics

As dozens of Invokana lawsuits continue to move forward through the federal court system over failure to warn about the risk of ketoacidosis and other injuries linked to that new-generation diabetes drug, a number of cases are now being filed by individuals who suffered similar side effects from Farxiga, a competing drug that is part of the same new class of diabetes medications.

In a complaint (PDF) filed in the U.S. District Court for the Southern District of New York on November 17, Kimberly Fowler indicates that she experienced the dangerous build up of acid in her blood known as diabetic ketoacidosis, alleging that Bristol-Myers Squbb and AstraZenca failed to adequately warn consumers and the medical community about the risks associated with their new Faxiga treatment.

Farxiga (dapagliflozin) was introduced in 2014, as the second member of a new class of medications known as s sodium glucose cotransporter-2 (SGLT-2) inhibitors. These drugs work in a unique way, impacting the normal function of the kidneys, and have been linked to a number of serious side effects during the few short years they have been on the market.

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Invokana (canagliflozin) was the first member of this class to hit the market, and has been the subject of a number of similar failure to warn lawsuits filed in recent months. Side effects of Invokana, Farxiga and other SGLT-2 inhibitors have been linked to reports of diabetic ketoacidosis, kidney failure, heart attacks and other risks that were not initially disclosed on the drug labels or prescribing information.

Fowler indicates that she began taking Farxiga in March 2015, and began to experience symptoms of ketoacidosis days later, including nausea, vomiting and abdomen pain. She was ultimately diagnosed with euglycemic diabetic ketoacidosis, and was hospitalized in an intensive care unit for four days.

“Defendants knew of the significant risk of diabetic ketoacidosis and kidney damage caused by ingestion of Farxiga. However, Defendants did not adequately and sufficiently warn consumers, including Plaintiff, or the medical community of the severity of such risks,” according to the lawsuit filed by Fowler. “To the contrary, Defendants conducted nationwide sales and marketing campaigns to promote Farxiga, and they willfully deceived Plaintiff, Plaintiff’s healthcare professionals, the medical community, and the general public as to the health risks and consequences of the use of Farxiga.”

As more and more individuals switch to Farxiga, Invokana or other SGLT-2 inhibitors, a steady stream of serious safety signals have emerged in post-marketing adverse event reports, leading the FDA to issue several warnings for consumers and the medical community over the past year.

On June 14, the FDA issued a drug safety communication ordering the makers of Invokana, Invokamet, Farxiga and Xigduo XR to add stronger label warnings about the risk of kidney damage. The warning came after more than 100 adverse event reports involving patients who suffered acute kidney injury, which may cause hospitalization or potentially lead to kidney failure and death.

The order came about a month after an investigation by federal health officials that also required new warnings about problems with diabetic ketoacidosis with Farxiga, Invokana and other members of the class.

Since a growing number of product liability lawsuits have been filed against Johnson & Johnson’s Janssen Pharmaceutical subsidiary over failure to warn about the same side effects of Invokana, the U.S. Judicial Panel on Multidistrict Litigation (JPML) is considering whether to consolidate and centralize those claims before one judge for coordinated pretrial proceedings. However, that panel is currently only considering including Invokana cases, as only a handful of Farxiga lawsuits have been filed nationwide to date.

Fowler presents claims of failure to warn, negligence, willful and wanton conduct or gross negligence, violation of Alabama liability laws, and loss of consortium, seeking both compensatory and punitive damages.

As Farxiga and Invokana injury attorneys continue to review cases, they expect that the number of claims will continue to grow, with potentially hundreds or thousands of Farxiga and Invokana lawsuits filed in the coming months and years.

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