The Judicial Panel on Multidistrict Litigation established a multidistrict litigation (MDL) in New York to hear claims of diabetic ketoacidosis and kidney damage allegedly caused by the Farxiga and Xigduo diabetes drugs. Farxiga and its sister drug Xigduo XR are manufactured by Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, and AstraZeneca AB.
Eighteen cases are currently involved in the litigation that has been consolidated under an MDL which is a process created to streamline more complex cases. Similar complaints are heard in one court before one judge in the interest of lowering court costs, allowing a faster outcome, and is generally more efficient. The Honorable Judge Lorna G. Schofield was assigned to the MDL formed in the Southern District of New York.
Farxiga and Xigduo XR Background
Farxiga and Xigduo XR are type II diabetes medications designed to lower patients’ blood glucose levels and are sodium cotransporter 2 (SGTL2) inhibitors. SGLT2 inhibitors block the pathways used by glucose (sugar) to get into the bloodstream lowering the patient’s blood sugar. However, when SGLT2 inhibitors are too effective in blocking the glucose pathways, the reduction in glucose may cause ketoacidosis and kidney damage. Additional SGLT2 inhibitors include Invokana and Jardiance and are also associated with the risk of ketoacidosis.
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Ketoacidosis Risks and Potential Damage
Diabetic ketoacidosis develops when the body is unable to get the sugar needed for energy because the body does not have enough insulin, the hormone that controls blood sugar. When the cells are unable to get sugar for energy, the body begins to break down fat and muscle for energy and ketones (fatty acids) are produced. Ketones enter the bloodstream, causing the chemical imbalance called diabetic ketoacidosis, according to WebMD.
Symptoms of ketoacidosis include dehydration, excessive urination, extreme fatigue, vomiting, abdominal pain, difficulty breathing, and altered mental conditions.
FDA Approval and Added Warning
The FDA initially approved Farxiga (dapagliflozin) on January 8, 2014 with Xigduo XR (dapagliflozin combined with metformin) approved shortly after on October 29, 2014.
On December 4, the FDA issued a safety communication revealing they had found 73 adverse events reported between March 2013 and May 2015 that required hospitalization because of ketoacidosis-related to SGLT2 inhibitors. The FDA noted adverse event reports “include only reports submitted to FDA, so there are likely additional cases about which we are unaware.”
Additional Serious Side Effects Linked to SGLT2 Inhibitors
Between March 2013 and October 2014, the FDA received 19 reports of urinary tract infections that developed into either life-threatening blood infections or kidney infections. These cases all required hospitalizations and some of the patients developed kidney failure requiring dialysis or intensive care treatment.
Increased Risk of Kidney Injuries Related to Farxiga and Xigduo
Recent reports have led to revised warnings on Farxiga and Xigduo XR labeling, according to the FDA, and now include information about acute kidney injury, as well as additional recommendations to minimize risks.
The FDA has received 101 confirmable cases of acute kidney injury which, in some cases involved hospitalization and dialysis from March 2013, when Invokana and Invokamet, (other diabetes medications), were approved, to October 2015.
Over half of the cases of acute kidney injury-a total of 58 percent, occurred within one month after the patient began taking the diabetes drug, Law360 wrote. Some cases were in patients who were younger than 65 years of age and some were dehydrated, suffered from low blood pressure, or were taking other medicines that had an affect on the kidneys, according to the FDA.
The FDA advises that health care professionals consider factors that may predispose patients to acute kidney injury before prescribing Farxiga and Xigduo XR among other diabetes medications. Such factors include, “decreased blood volume; chronic kidney insufficiency; congestive heart failure”; as well as taking other drugs “that may increase the risk through interaction, “such as diuretics, blood pressure medicines known as angiotensin-converting enzyme (ACE) and angiotensin receptor blockers (ARBs); and nonsteroidal anti-inflammatory drugs (NSAIDs). Doctors should assess patient kidney function prior to starting these medications and should continue with regular, periodic monitoring, according to the FDA.