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 Farxiga?
Farxiga (generic: dapagliflozin) is used to control blood sugar levels in patients with type 2 diabetes. The drug is classified as a SGLT2 inhibitor, and works by increasing the removal of sugar from the kidneys. Farxiga was released in a partnership between Bristol-Myers Squibb and AstraZeneca, and approved by the FDA on January 8, 2014.
FDA Warns of New Diabetes Medication Side Effects
On May 15, 2015, the FDA issued a warning which stated that Farxiga and other SGLT2 inhibitor diabetes medications may cause dangerously high levels of blood acids that could require the need for emergency hospitalization. Between March 2013 and June 6, 2014, the agency received at least 20 reports of “diabetic ketoacidosis,” “ketoacidosis” or “ketosis” in patients who took SGLT2 inhibitors. All patients required hospitalization or a trip to the emergency room to treat the problem, according to the FDA.
Signs of Ketoacidosis
If you don’t have enough insulin to help your body break down sugars (glucose), your body will start burning fat to create energy. As a result, acids called ketone bodies build up in the body. If left untreated, these ketone bodies poison you.
Symptoms of ketoacidosis include:
- Difficulty breathing
- Abdominal pain
Most cases of ketoacidosis are treated with fluids, electrolytes and insulin. Perhaps surprisingly, the most common complications of ketoacidosis are related to this treatment:
- Low blood sugar (hypoglycemia)
- Low potassium (hypokalemia)
- Swelling in the brain (cerebral edema)
If left untreated, the risks are much greater. Untreated ketoacidosis can lead to loss of consciousness and even death.
Which Drugs are SGLT2 Inhibitors?
In addition to Farxiga, other diabetes medications in the SGLT2 inhibitor class include:
- Invokana (canagliflozin)
- Invokamet (canagliflozin/metformin)
- Jardiance (empagliflozin)
- Xigduo XR (dapagliflozin/metformin HCl extended-release)
- Glyxambi (empagliflozin and linagliptin)
Farxiga Side Effects
- Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Ketoacidosis)
- Heart Attack
- Kidney Damage
- Kidney Failure (Renal Failure)
- Kidney Cancer
- Kidney Stones
- Bone Fractures
- Bone Abnormalities
- Testicular Cancer
- Urinary Tract Infections (UTIs)
- Severe Dehydration / Fluid Imbalance
- Abnormal Weight Loss
- Hypersensitivity (Allergic Response)
- Blood Infections (Urosepsis)
- Fungal Infections
Farxiga 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.
MDL Requested for Farxiga Lawsuits
February 22, 2017 – Plaintiffs lawyers have filed a motion to consolidate all federal Farxiga lawsuits into a multidistict litigation (MDL) in the U.S. District Court for the Eastern District of Pennsylvania. At the time of the filing, there were at least 18 lawsuits pending in 6 federal courts, but this number is expected to grow significantly in the coming weeks and months.
FDA Warns of Acute Kidney Injury Risk with Farxiga
June 14, 2016 – The U.S. Food & Drug Administration (FDA) has strengthened existing warnings regarding an increased risk of acute kidney injury from the SGLT2 inhibitor diabetes drugs Invokana, Invokamet, Farxiga and Xigduo XR. Since October 2015, FDA has received over 100 confirmable cases of the condition associated with the medications, some of which required hospitalization and dialysis. This number includes only reports submitted to FDA, so there are likely many additional cases that went unreported.
New Analysis Highlights Ketoacidosis Risk Among Farxiga Users
February 1, 2016 – Adverse event reports of diabetic ketoacidosis (DKA) among patients treated with SGLT2 inhibitors like Farxiga continue to be submitted to the U.S. Food & Drug Administration (FDA). According to the latest QuarterWatch (PDF) published by the Institute for Safe Medications Practices (ISMP), the agency received at least 80 reports of DKA associated with Farxiga during the 12-month period ending June 30, 2015. Experts estimate the actual number of Farxiga users with the condition is much higher, as the majority of cases typically go unreported.
New Combination Diabetes Drug Rejected by FDA
October 16, 2015 – The FDA has denied an application to approve a fixed-dose combination of saxagliptin (the active ingredient in Onglyza) and dapagliflozin (the active ingredient in Farxiga), according to Reuters. AstraZeneca announced today that it had received a “complete response letter” from the agency stating that more clinical data are needed before the medication can be approved.
Has There Been a Recall?
To date, no recall has been issued for Farxiga in the U.S. or any other country. However, patients who suffered injury after taking the drug may be able to file a claim against the manufacturer seeking compensation for medical bills, lost wages, pain and suffering, and more.
Do I Have an Farxiga Class Action Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Farxiga lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one has been injured by the side effects of Farxiga, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.