These New Diabetes Drugs Have Increased Risks Of Serious Side Effects Such As Diabetic Ketoacidosis (DKA) And Acute Kidney Injury
Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin and metformin extended-release) are diabetes medicines in the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors class of drugs.
These relatively new diabetes drugs are from AstraZeneca Pharmaceuticals and were initially approved in 2014 by the FDA.
In June 2016 the FDA announced it had strengthened the existing warning about the risk of acute kidney injury for Farxiga and Xigduo XR by means of issuing this document, "FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)".
Prior to that time the FDA was mostly investigating a connection between Farxiga and Xigduo XR with these several other drug side effects: diabetic ketoacidosis (DKA); ketoacidosis; and, ketosis.
Related to these various safety issues, in the legal realm, there have been drug injury lawsuits filed involving Farxiga and Xigduo XR.
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Those lawsuits recently gave rise to a request for the consolidation of all Farxiga and Xigduo XR cases pending in the various federal court districts around the country before one judge. This legal motion is scheduled to be heard by United States Judicial Panel On Multidistrict Litigation (JPML) on March 30, 2017.
From this court document we get the following information about this proposed federal court multidistrict litigation, or MDL, for Farxiga and Xigduo XR:
- This motion for transfer involves eighteen pending cases in six district courts asserting similar claims....
- Each of these Actions arise from the same or similar operative facts and wrongful conduct alleging that, as a result of ingesting Farxiga, Plaintiffs have suffered sudden onset of life-threatening diabetic ketoacidosis (often in the setting of normal blood glucose levels), and/or acute renal failure, and/or pyelonephritis (kidney infection) and/or urosepsis and continue to suffer from the sequelae of these injuries. Farxiga (dapagliflozin) is a pharmaceutical drug used to treat Type 2 Diabetes. All of these injuries were the subject of recent FDA safety advisories....
- ... Judge [Lorna G.] Schofield in the Southern District of New York is already presiding over the vast majority of the Farxiga cases filed nationally. She has already conducted a pretrial conference to attempt to coordinate the cases pending before her. Continuing with that process would prevent any further delay in those cases. Further, Defendant Bristol-Myers Squibb has its principal place of business in New York....
- If the Panel should decide that transfer to the Southern District of New York is not warranted, Plaintiff requests in the alternative, Transfer to either the Eastern District of Pennsylvania before Judge Mitchell Goldberg, or the Southern District of Illinois before Judge Nancy J. Rosenstengel.
We will watch for the JPML determination about whether or not to establish this Farxiga / Xigduo XR MDL and report that result in an update to this article some time after the hearing, which is scheduled for March 30, 2017.
We are currently investigating possible Xigduo XR and Farxiga drug injury lawsuits against AstraZeneca Pharmaceuticals, the responsible pharmaceutical company, for diabetes patients who have developed any of the medical conditions listed above.
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