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According to allegations raised in a product liability lawsuit filed against Bristol-Myers Squibb and AstraZeneca, side effects of Farxiga and Xigduo caused an Indiana man to be hospitalized with diabetic ketoacidosis and suffer an acute kidney injury, which he indicates could have been avoided if the drug makers had properly disclosed the risks associated with their new-generation diabetes treatment.
The complaint (PDF) was filed in the U.S. District Court for the Southern District of Indiana on January 25, by John Grogan and his wife, Victoria, indicating that the drug makers actively concealed the significant risks associated with Farxiga and Xigduo XR, which both contain the active ingredient dapaglifolzin.
John Grogan began taking Farxiga in July 2014, shortly after it was introduced as a new type of treatment for type 2 diabetes. He subsequently took both Farxiga and the combination drug Xigduo XR, which combines Farxiga with the older diabetes medication metformin. Farxiga and Xigduo XR are both part of a controversial new class of medications known as sodium glucose cotransporter-2 (SGLT-2) inhibitors, which have been linked to a number of serious side effects in recent years.
On January 25, 2016, Grogan indicates that he experienced diabetic ketoacidosis, which involves elevated levels of acid in the blood, which is considered a medical emergency and resulted in hospitalization. Grogan also indicates that he suffered an acute kidney injury, which involves abrupt loss of renal function.
“Defendants knew or should have known the risks associated with using Farxiga and/or Xigduo XR, dapagliflozin containing products, including the risk of developing diabetic ketoacidosis and acute kidney failure, prior to Plaintiffs’ use of the Farxiga and/or Xigduo XR,” the lawsuit states. “Despite Defendants superior knowledge of the true risks posed by the use of Farxiga and/or Xigduo XR, Defendants did not warn about the risks of DKA and/or kidney injury prior to Plaintiffs ingesting Farxiga and/or Xigduo XR.”
In December 2015, diabetic ketoacidosis warnings were added to Farxiga, Xigduo XR and other SGLT2 inhibitors, indicating for the first time that users may face of risk of developing this serious condition.
Prior warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting, which is critical for avoiding serious complications from diabetic ketoacidosis.
Concerns about a potential link between SGLT-2 inhibitors and kidney failure have also emerged since the drugs hit the market. In June 2016, the FDA required that new information be added to the drug label about the risk of acute kidney injury and other kidney issues.
Plaintiffs claim that the drug makers failed to adequately research the potential side effects before aggressively marketing the new generation diabetes treatments.