Update: SGLT2 Inhibitor Drugs Linked to Flesh-Eating Genital Infections
August 29, 2018 – FDA is warning that type-2 diabetes drugs from the SGLT2 inhibitor class have recently been linked to a gruesome type of genital infection called necrotizing fasciitis of the perineum, also known as Fournier’s gangrene. The condition has been conclusively diagnosed in at least a dozen patients, all of whom required hospitalization and surgery, including one who died from complications resulting from the condition.
What is Xigduo XR?
Xigduo XR (generic: dapagliflozin and metformin HCl) is a prescription sodium-glucose cotransporter-2 (SGLT2) inhibitor drug used to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin works by helping the kidneys remove glucose from the blood, and metformin lowers glucose production in the liver and causes the intestines to absorb less glucose. Xigduo XR is made by AstraZeneca, and was approved by the U.S. Food & Drug Administration (FDA) in October 2014.
New Diabetes Medications May Cause Ketoacidosis: FDA Warning
On May 15, 2015, FDA issued a Drug Safety Communication warning that SGLT2 inhibitors had been linked to ketoacidosis (also known as DKA, diabetic acidosis, metabolic acidosis or ketoacidosis), a condition that occurs when the body cannot use sugar (glucose) as a fuel source because there is not enough insulin.
According to the warning, at least 20 cases of ketoacidosis in SGLT2 users were reported to the FDA between March 2013 and June 6, 2014. All 20 patients had to go to an emergency room or required hospitalization, according to the FDA. As a result of these problems, the agency required that SGLT2 inhibitor labels be updated with information about the ketoacidosis risk. If left untreated, DKA can lead to a diabetic coma or even death, according to the American Diabetes Association (ADA).
- Decreased alertness
- Rapid breathing
- Dry skin / mouth
- Flushed face
- Frequent urination
- Fruity-smelling breath
- Muscle stiffness or aches
- Nausea / vomiting
- Abdominal pain
Ketoacidosis typically affects type 1 diabetics; however, all cases reported to the FDA associated with SGLT2 inhibitors involved patients with Type 2 diabetes. The condition also manifested itself slightly differently than in people with type 1 diabetes, the agency said. FDA is investigating the issue and will determine whether labeling changes should be made to the drugs.
SGLT2 Inhibitor List
In addition to Xigduo XR, other type 2 diabetes medications in the SGLT2 inhibitor class include:
- Invokana (canagliflozin)
- Invokamet (canagliflozin/metformin)
- Jardiance (empagliflozin)
- Farxiga (dapagliflozin)
- Glyxambi (empagliflozin and linagliptin)
FDA recommends that diabetics who take SGLT2 inhibitors should monitor themselves for signs of ketoacidosis and seek immediate medical attention if they develop any of the symptoms listed above. Ketones can be detected with a simple urine test.
You should never stop taking a prescription medication without talking to your doctor first. If a diagnosis of ketoacidosis is confirmed, doctors should discontinue treatment with SGLT2 inhibitors in favor of a medication with fewer side effects, according to the FDA.
Xigduo Side Effects
- Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Metabolic Acidosis, Ketoacidosis)
- Heart Attack
- Kidney Failure (Renal Failure)
- Kidney Cancer
- Kidney Stones
- Bone Fractures
- Bone Abnormalities
- Testicular Cancer
- Urinary Tract Infections (UTIs)
- Lactic Acidosis
- Severe Dehydration / Fluid Imbalance
- Abnormal Weight Loss
- Hypersensitivity (Allergic Response)
- Blood Infections (Urosepsis)
- Fungal Infections
Has a Recall Been Issued?
There is currently no recall for Xigduo XR in the U.S. or any other country; however, a black box warning about lactic acidosis has been included on the drug’s labeling. This condition occurs when lactic acid builds up in the bloodstream faster than it can be removed, and produces symptoms such as nausea and weakness. Patients concerned they may have lactic acidosis should go to a hospital immediately.
Xigduo XR Litigation Centralized in New York
April 13, 2017 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered that all federal lawsuits involving Farxiga and Xigduo XR be centralized for pretrial handling in the Southern District of New York. JPML agreed that the actions share factual questions arising from the allegations, thus implicating numerous common issues concerning the development, manufacture, testing, regulatory history, promotion, and labeling of Farxiga and Xigduo XR.
Kidney Injury Warning Upgraded on SGLT2 Inhibitors
June 14, 2016 – FDA has announced stronger warnings regarding acute kidney complications on the labeling of Invokana, Invokamet, Farxiga and Xigduo XR. The increased warnings were issued in response to at least 101 reports of acute kidney injury in type 2 diabetes patients treated with the SGLT2 inhibitors between March 2013 and October 2015, according to the FDA.
Do I Have an Xigduo XR Class Action?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Xigduo XR lawsuits. We are handling individual litigation nationwide and currently accepting potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one has been injured by the side effects of Xigduo XR, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.