The Judicial Panel on
Multidistrict Litigation established MDL No. 2776 in the Southern District of New
York to hear claims of diabetic ketoacidosis and kidney damage caused by the
Farxiga and Xigduo diabetes drugs. The cases were assigned to Judge Lorna G.
Schofield.
The defendants are Bristol-Myers
Squibb and AstraZeneca. The JPML stated that the 18 actions currently pending
in six federal district courts share common questions of fact and would benefit
from a centralized pre-trial MDL docket.
Farxiga, and its sister drug
Xigduo XR, belong to a class of diabetes drugs known as Sodium Glucose
Cotransporter 1 2 (SGLT2) inhibitors. Other SLGT2 inhibitors include Invokana
(canagliflozin) and Jardiance (empagliflozin). The FDA approved Farxiga for
treatment in type 2 daibetes on January 8, 2014. Xigduo XR was approved shortly
after Farxiga, on October 29, 2014.
The actions share factual
questions arising from allegations that taking Farxiga or Xigduo XR may result
in patients suffering kidney-related injuries, such as diabetic ketoacidosis
and kidney damage.
Plaintiffs are claiming the following injuries:
- sudden onset of life-threatening diabetic ketoacidosis (often in the setting of normal blood glucose levels)
- acute renal failure
- pyelonephritis (kidney infection)
- urosepsis (life-threatening blood infections)
- death
Some of these injuries were the
subject of recent FDA safety advisories. In fact, On December 4, 2015, the FDA
issued a safety communication disclosing they had found 73 adverse events
reported between March 2013 and May 2015 that required hospitalization due to
ketoacidosis in SGLT2 inhibitor users.
Based on this disclosure, the FDA
changed the label for Farxiga and Xigduo XR to include a warning “about the
risks of too much acid in the blood” and urged patients taking SGLT2 inhibitors
to stop taking the drug and seek immediate medical attention if they have any
symptoms of ketoacidosis. The FDA also required a label change to warn of
urosepsis and pyelonephritis.
On June 14, 2016, the FDA issued
a safety announcement that advised that the existing warning about the risk of
acute kidney injury on the Farxiga and Xigduo labels would be strengthened.
Pittman, Dutton & Hellums, P.C., is currently
investigating claims against the manufacturers of Farxiga. If you or a loved
one believe you were injured as a result of taking Farxiga, please contact Booth Samuels
at booths@pittmandutton.com or call toll free 1-866-515-8880.
