The Food and Drug Administration (FDA) recently announced a warning that the common diabetes medicines under the class of sodium-glucose cotransporter-2 (SGLT2) inhibitors has been linked to a rare but serious flesh-eating genital infection. Below, the pharmaceutical liability lawyers at The Law Offices of Peter Angelos provide an overview of the FDA’s findings and what you should know about the side effects of these widely used diabetes drugs.
Overview of SGLT2 Inhibitors and their Uses
SGLT2 inhibitors, first approved by the FDA in 2013, were developed to help lower blood sugar in adults with type 2 diabetes. The drug works by causing the kidneys to eliminate excess sugar from the body through urine. Specific medicines labeled under the category of SGLT2 inhibitors include canagliflozin, dapagliflozin, empagliflozin and ertugliflozin. Additional SGLT2 inhibitors that are commonly used to treat type 2 diabetes in adults include Johnson & Johnson’s Invokana, AstraZeneca Plc’s Farxiga and Eli Lilly & Co.’s Jardiance. These three drugs were approved by the FDA in 2013, 2013 and 2016, respectively.
Twelve Patients Developed Fournier’s Gangrene With SGLT2 Inhibitor Usage
The infection associated with SGLT2 inhibitors is called necrotizing fasciitis of the perineum, also known as Fournier’s gangrene, and since 2013 has been diagnosed in at least 12 patients that were prescribed SGLT2 inhibitors. Of the 12 victims, seven were men and five were women, and all were hospitalized and surgically treated. One patient ultimately died of complications from the infection. The FDA estimates that 1.7 million patients received a prescription for one of the medicines in this class of drug, and according to Bloomberg Intelligence, the drugs are predicted to generate nearly $7.1 billion in sales by the year of 2020.
The FDA Calls For Warning to Be Listed Regarding SGLT2 Inhibitors
The FDA posted a statement on August 29th requiring a warning about the infection to be added to the prescribing information about SGLT2 inhibitors and to the patient Medicine Guide after it was found that SGLT2 inhibitors increase the risk of developing Fournier’s gangrene. The FDA also recommends patients seek medical assistance immediately if any redness, pain, swelling or tenderness of the genitals or surrounding areas occur, especially as the symptoms associated with Fournier’s gangrene can worsen quickly.
Speak to a Lawyer at The Law Offices at Peter Angelos
Fournier’s gangrene is a severe and even deadly infection—a patient who is prescribed an SGLT2 inhibitor as treatment for type 2 diabetes may be at risk of developing this infection. The Law Offices of Peter Angelos has decades of experience representing victims of pharmaceutical liability and is prepared to help victims and their families, who have been injured or affected by a dangerous drug, receive the compensation they deserve. If you or a loved one has been affected by Fournier’s gangrene as a result of taking an SGLT2 inhibitor as treatment for type 2 diabetes, schedule a free consultation today.