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According to allegations raised in a recent lawsuit filed against Bristol-Myers Squibb and AstraZeneca, side effects of Farxiga caused an Alabama woman to suffer diabetic ketoacidosis (DKA), kidney damage and kidney failure after she switched to the new-generation diabetes drug.
In a complaint (PDF) filed earlier this month in the U.S. District Court for the Southern District of Alabama, Jamie Michelle Foran alleges that the drug makers failed to adequately warn her or her physicians about the serious health risks associated with Farxiga, which was just introduced in 2014 as the second member of a new class of diabetes drugs, known as sodium glucose cotransporter-2 (SGLT-2) inhibitors.
Foran indicates that she was prescribed Farxiga for treatment of type 2 diabetes in July 2014, only months after it was approved by the FDA. Less than two months later, in September 2014, she indicates that she was hospitalized due to ketoacidosis. She also later suffered severe kidney damage and renal failure, according to the complaint.
Farxiga works in a unique way, impacting the normal function of the kidneys to control glucose levels. It was introduced to compete with Invokana, which was the first SGLT-2 inhibitor approved by the FDA about a year earlier. Other members of this new class of diabetes drugs include Invokamet, Xigduo XR, Jardiance and Glyxambi, which have all been aggressively marketed to diabetics during the short time they have been on the market, encouraging diabetics to switch from older treatment options.
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, including diabetic ketoacidosis.
Ketoacidosis is a serious medical emergency linked to SGLT-2 inhibitor side effects, which causes an increase in the body’s blood acid levels and usually results in serious injury and hospitalization. It can also lead to coma and death.
“An analysis of the FDA adverse event database shows that patients taking Farxiga are several times more likely to report diabetic ketoacidosis than those taking non-SGLT2 diabetes drugs to treat diabetes,” the lawsuit states. “Despite Defendants’ knowledge of the increased risk of severe injury among Farxiga users, Defendants did not warn patients but instead continued to defend Farxiga, by misleading physicians and the public, and minimizing unfavorable findings.”
On June 14, the FDA issued a drug safety communication ordering the makers of Farxiga, Invokana, Invokamet, and Xigduo XR to add stronger label warnings about the risk of kidney damage. The warning comes 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.
That 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, which involves a dangerous build up of acid levels in the blood that can result in emergency hospitalization and permanent injury.
There are also increasing concerns about a link between Farxiga and kidney problems, as the drug works in a unique way by impacting the normal functioning of the kidneys.
The kidney risks were first highlighted by an independent review of adverse event reports submitted to the FDA during the first year Invokana was on the market. In May 2015, the Institute of Safe Medication Practices (ISMP) released a report highlighting 457 reports involving problems with Farxiga or other members of this same new class of diabetes drug, including instances of kidney failure, kidney impairment or problems with kidney stones, urinary tract infections, dehydration, hypersensitivity and abnormal weight loss.
On June 14, the FDA appeared to agree with the ISMP’s concerns and 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 as well. The warning came after the FDA confirmed 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.
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.