The Jardiance and Farxiga lawsuits claim the manufacturer of these diabetes drugs failed to warn users of the increased risk of experiencing Fournier's Gangrene.
What Do We Know About the Jardiance and Farxiga Lawsuits
In August 2018, the U.S. Food and Drug Administration (FDA) issued a warning that Jardiance (empagliflozin) and Farxiga (dapagliflozin) have been associated with Fournier's Gangrene, a rare but deadly flesh-eating bacteria of the genitalia and perineum area. These two diabetes medications are part of a class of drugs known as SGLT2 inhibitors.
Both Jardiance and Farxiga have been linked to an increase in Fournier's Gangrene, especially among women under the age of 50.
Before the approval of the first SGLT2 inhibitors to treat diabetes, there were only 19 reported cases of Fournier's Gangrene over a period of more than 30 years related to the use of diabetic drugs. Yet, during the 15 year period after the approval of SGLT2 inhibitors, there were a total of 55 cases of Fournier's Gangrene reported to be linked with the use of the drug.
What is even more unusual about this is that one-third of the 55 victims were female, and were as young as 33 years of age. Fournier's Gangrene typically impacts males over the age of 50.
What Do We Know About Fournier's Gangrene
Fournier's Gangrene (also known as necrotizing fasciitis) is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. It was first identified in the mid-18th century. Generally, it affects approximately 1 person in 62,500 per year, with male victims outnumbering females 40 to 1.
Symptoms of Fournier’s Gangrene include swelling or sudden pain in the affected area of the body, along with fever and overall weakness and fatigue. Severe cases may present a foul odor, accompanied by a discharge of pus often associated with bacterial infections.
A 2006 study from researchers at Istanbul University found that 46% of patients diagnosed with Fournier's Gangrene suffered from elevated glucose levels. Other risk factors include alcoholism, malnutrition, and suppression of the immune system due to chemotherapy or other drug therapies.
Prior to the introduction of SGLT2 inhibitors, Fournier's Gangrene was exceedingly rare.
Other Complications and Side Effects Related to Farxiga and Jardiance
In addition to Fournier's Gangrene, SGLT2 inhibitors such as Farxiga and Jardiance have been linked to the following adverse effects:
- acute pancreatitis (inflammation of the pancreas)
- allergic hypersensitivity and respiratory distress (similar to anaphylaxis)
- cardiovascular disease
- diabetic ketoacidosis (dangerous rise in blood acidity)
- hypoglycemia (dangerously low blood glucose levels)
- hypotension (seriously low blood pressure)
- lower limb amputations
- serious kidney injury and renal failure
- urinary and bladder infections
- urosepsis (a blood infection)
What Do We Know About Farxiga and Jardiance
Jardiance (empagliflozin) and Farxiga (dapagliflozin) are two of the most popular diabetes medications prescribed today and are part of a class of drugs known as SGLT2 inhibitors.
Medications such as Jardiance and Farxiga were initially hailed by the medical community because of their effectiveness in lowering hemoglobin A1C levels, a primary measure of blood sugar control. Their mechanism of action disables the action of a protein known as sodium glucose cotransporter 2 (SGLT2), which occurs mainly in the kidneys and plays a significant role in maintaining normal blood sugar levels.
The function of SGLT2 is to facilitate the re-absorption of excess glucose in the kidneys, after which it is re-released into the bloodstream. By disabling the action of SGLT2, excess blood sugar is passed through the urine, thus lowering glucose levels. Medical scientists believe this mechanism of action is what raises the risk of Fournier's Gangrene.
Other serious side effects that have been associated with the use of SGLT2 inhibitors such as Jardiance and Farxiga include amputations, kidney damage, and ketoacidosis.
Are Farxiga and Jardiance the Same Drug
Although both Farxiga (dapagliflozin) and Jardiance (empagliflozin) are members of the same pharmaceutical class and are associated with many of the same health risks, the two drugs have slightly different formulas. Therefore, some of the side effects are different.
For example, patients who have taken Farxiga have reported:
- hyperphosphatemia (high levels of phosphorus in the blood)
- pain in the back and extremities
- predisposition to colds and flu
Those who take Jardiance have suffered from:
- joint pain and inflammation
- respiratory tract infections
It appears the risk of cardiovascular disease is lower among patients taking Jardiance compared to those who have been prescribed Farxiga and other SGLT2 inhibitors.
FDA and Scientific Studies Regarding Farxiga and Jardiance Link to Fournier’s Gangrene
Fournier Gangrene Associated With Sodium–Glucose Cotransporter-2 Inhibitors: A Review of Spontaneous Postmarketing Cases
Use of sodium–glucose cotransporter-2 (SGLT2) inhibitors has been associated with Fournier gangrene (FG), a rare urologic emergency characterized by necrotizing infection of the external genitalia, perineum, and perianal region. To read more, click Annals of Internal Medicine
FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. We are requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide. To read more, click FDA Drug Safety Communication