The Food and Drug Administration (FDA) has issued a warning that a number of commonly used diabetes medications following under the sodium-glucose cotransporter-2 (SGLT2) inhibitors category have been correlated with a rare yet very dangerous flesh eating genital infection.
The FDA first approved SGLT2 inhibitors in 2013. They were developed to help reduce blood sugar levels in adults diagnosed with type 2 diabetes. These inhibitors operate by causing the kidneys to remove excess levels of sugar from the body through the urine. Medicines that are categorized under the heading of SGLT2 inhibitors include dapagliflozin, canagliflozin, ertugliflozin, and empagliflozin.
As well, Farxiga by AstraZeneca Plc, Invokana by Johnson & Johnson, and Jardiance by Eli Lilly & Co., are additional SGLT2 inhibitors routinely used to treat adults with type 2 diabetes. These drugs received FDA approval in 2013, 2013, and 2016, respectively.
Fournier’s gangrene diagnosed in 12 patients from SGLT2 inhibitor use
“Necrotizing fasciitis of the perineum” is the term used for the infection resulting from the use of SGLT2 inhibitors in some rare, but serious cases. The condition is also known Fournier’s gangrene. As a life-threatening but considerably rare bacterial infection causing local disfigurement, it affects the tissue under the skin that surrounds the fat, nerves, muscles, and blood vessels of the perineum.
According to the FDA, the bacteria usually enter the body through a break or cut in the skin. Between March 2013 and May 2018, at least 12 individuals who were prescribed SGLT2 inhibitors have been diagnosed with the infection. Of these dozen victims, five were women and seven were men, and all were treated with surgery at a hospital. Unfortunately, one patient eventually died of complications resulting from the infection.
According to the FDA, about 1.7 million patients obtained a prescription for medicine containing SGLT2 inhibitors. Bloomberg Intelligence reports that these drugs are expected to bring in over $7 billion in sales by the 2020.
FDA requires new warnings accompany SGLT2 inhibitor prescriptions
On August 29, the FDA issued a statement that SGLT2 inhibitors must have a warning attached to the prescribing information of the drug and the patient Medicine Guide that indicates the associated risk of developing Fournier’s gangrene. The FDA encourages patients to obtain medical assistance immediately if symptoms such as pain, redness, tenderness or swelling of the genitals or surrounding areas occur. The symptoms may also accompany a fever of more than 100.4°F or a general “unwell” feeling. Patient should understand that symptoms related to Fournier’s gangrene can quickly grow worse.
As noted, Fournier’s gangrene is a serious and possibly deadly infection that carries a certain amount of risk to any patient who has been prescribed an SGLT2 inhibitor for the treatment of type 2 diabetes. If you or someone you love has incurred such an infection, you may have the right to recover significant financial compensation for your losses.
At Taylor & Ring, we work tirelessly on behalf of our clients who have suffered severe injuries resulting from the negligence of others. Whether you have suffered the consequences of a severe infection resulting from an SGLT2 inhibitor prescription, or another devastating injury, we are here to support you with strong advocacy to help you recover the compensation you deserve. To set up a free consultation with one of our Los Angeles personal injury attorneys, call us today at 310.776.6390 or fill out our contact form.