FDA Issues New Warning for Invokana Diabetes Drugs

The U.S. Food and Drug Administration (FDA) recently issued a new safety alert regarding the increased risk of Fournier’s gangrene among diabetes patients using Invokana and other drugs in the same class. Fournier’s gangrene is considered to be a rare, but very serious complication of SGLT2 inhibitors. This condition is an infection of the genitals and the area around the genitals. The infection can progress quickly, killing tissue and potentially leading to death.

FDA warns patients about Invokana, related drugs

The FDA safety alert, which was issued on August 29, 2018, specifically identifies canagliflozin, the generic name for Invokana, as raising the risk of necrotizing fasciitis of the perineum. The safety alert also identifies other, related drugs, dapaliflozin (Farxiga), empagliflozin (Jardiance), and ertugliflozin (Steglatro). All of these medications are sodium-glucose cotransporter-2 (SGLT2) inhibitors that work to lower blood sugar by triggering the kidneys to take out more sugar from the body and excrete it in the urine.

Risk of side effects from diabetes drugs

For many patients with type 2 diabetes, medications remain an essential part of treating this life-threatening disease, along with a healthy diet and exercise. And it’s important that patients avoid abruptly discontinuing a prescribed medication without consulting their doctors first. However, the recent safety alert by the FDA may prompt some patients to discuss the potential risks with their doctors even in the absence of symptoms.

Fournier’s gangrene isn’t the only life-threatening complication tied to Invokana and other SGLT2 inhibitors. These drugs are also linked to an increased risk of the following:

• Kidney failure
• Hyperkalemia (high levels of potassium in the bloodstream)
• Ketoacidosis
• Hypotension
• Increased bladder cancer risk
• Serious urinary tract infections that lead to blood infections
• Leg and foot amputations

In 2017, the FDA required manufacturers to include a black box warning—the most serious warning available—to warn patients about the potential risk of amputations.

Invokana and related drug litigation

As public awareness grows regarding the link between Invokana and serious complications, increasing numbers of lawsuits have been filed against the manufacturers of SGLT2 inhibitors. At the end of 2016, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered that all federal Invokana cases be consolidated into a multidistrict litigation (MDL). MDL 2750 is currently proceeding in the U.S. District Court for the District of New Jersey. The presiding judges are Brian R. Martinotti and Lois H. Goodman.

The Farxiga & Invokana lawsuits share similar allegations, including the claim that the defendants, Johnson & Johnson’s subsidiary company, Janssen Pharmaceuticals, knew about the risk of severe medical complications and failed to warn doctors and patients. The lawsuits also claim that the defendants failed to conduct appropriate pre-market safety testing on the diabetes drug.

Know the signs and symptoms of Fournier’s gangrene

The FDA has urged patients to seek immediate medical attention if they observe any of the possible symptoms of Fournier’s gangrene. Patients taking Invokana should be aware of these signs and symptoms. They include:

• A general feeling of being unwell
• A fever higher than 100.4 degrees Fahrenheit
• Redness, swelling, or tenderness of the genitals or genital area

Additional Resources:

1. U.S. Food and Drug Administration, FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes, https://www.fda.gov/Drugs/DrugSafety/ucm617360.htm
2. MedicineNet.com, SGLT2 Inhibitors, https://www.medicinenet.com/sglt2_inhibitors_type_2_diabetes_drug_class/article.htm