The condition, known as "necrotizing fasciitis of the perineum," or Fournier's gangrene, has only affected 12 diabetes patients over a five-year span (seven men and five women), one of whom died - so if you come down with it the support group is going to be small. Also, if you'd like to never eat again, click here (don't do it).
The drugs covered by the warning include Johnson & Johnson’s Invokana, AstraZeneca Plc’s Farxiga and Eli Lilly & Co.’s Jardiance. Known as SGLT2 inhibitors, they were approved in 2013, 2013 and 2016, respectively. The drugs help the body lower blood-sugar levels via the kidneys, and excess sugar is excreted in a patient’s urine. Urinary tract infections are a known side effect. -Bloomberg
This is horrifying. Flesh-eating bacterial infection of the genitals linked to best-selling diabetes drugs (like $AZN's Farxiga, $JNJ's Invokana and $LLY's Jardiance). Just a dozen cases in the 5 years on the market, but all severe and one death. Yikes. Be cautious.— Michelle Fay Cortez (@FayCortez) August 29, 2018
Cortez notes that in the past three decades, the FDA only found six other cases of the condition - all men, while reviewing all other diabetes drug classes.
The FDA estimates apprximately 1.7 million patients were prescribed one of the affected medications from a retail pharmacy in 2017, while Bloomberg Intelligence believes the drugs are anticipated to generate as much as $7.1 billion in sales by 2020.
All of the drugs in the class except Merck & Co.’s Steglujan, the most recently approved, have been linked to the condition. The manufacturers must add information about the risk to the prescribing information and medicine guides given to patients. AstraZeneca said it is working with the agency on updating the label and noted that it hadn’t seen any cases of the condition during the development of Farxiga. -Bloomberg
And now for the fine print from the FDA:
- Patients should seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.
- Health care professionals should assess patients for Fournier’s gangrene if they present with the symptoms described above. If suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary. Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.
- Publications report that Fournier’s gangrene occurs in 1.6 out of 100,000 males annually in the U.S., and most frequently occurs in males 50-79 years (3.3 out of 100,000).1-3 In our case series, however, we observed events in both women and men.