(August 30, 2018) Invokana and other diabetes drugs like Farxiga and Jardiance can cause a flesh-eating bacterial infection in the genitals. The U.S. FDA warned doctors and patients yesterday about the risk of infection from these popular diabetes’ drugs.
The FDA announced that it found the flesh-eating genital infection risk linked with drugs from Johnson & Johnson, AstraZeneca, and Eli Lilly. The agency found the “side effect” had occurred in at least 12 patients, one of whom died.
Known as Fournier’s gangrene, the condition developed in a dozen patients shortly after they began taking the medicines between March 2013 and May 2018. The FDA reported that seven men and five women who suffered the infection were all hospitalized. They all underwent surgery for the condition, including the patient who died.
An FDA statement said that more cases might be uncovered once the risk is better understood.
FDA’s Diabetes Drug Warning over Genital Infections
The warning covered these drugs: Johnson & Johnson’s Invokana, AstraZeneca Plc’s Farxiga, and Eli Lilly & Co.’s Jardiance — SGLT2 inhibitors that were approved in 2013, 2013, and 2016. They are designed to help the body lower blood-sugar levels through the kidneys, by helping excrete excess sugar through the urine. One known side effect of these drugs is urinary tract infections. Another is that they raise the risk of amputations.
The FDA found just six reported cases of the flesh-eating bacterial condition in a review of all other diabetes drug classes for the past three decades; but one has to wonder how many cases went unreported. How many people had the diabetes drug “side effect” of a flesh-eating genital infection without relating it to their diabetes drug?
These SGLT2 diabetes drugs are expected to generate as much as $7.1 billion in sales by 2020, says Bloomberg Intelligence. The FDA estimates that some 1.7 million patients filled a prescription for one of these meds from a retail pharmacy in 2017.
All of the drugs in the SGLT2 class except Merck & Co.’s Steglujan have been linked to the flesh-eating infection condition. The FDA warning demands that the drug makers add information about the risk to the prescribing information and medicine guides given to patients. AstraZeneca said it is working with the FDA on updating its label.
Officials at J&J and Eli Lilly didn’t return phone calls and emails from Reuters News requesting comment.
The FDA said that diabetics using these drugs should seek immediate medical help if they develop tenderness, redness or swelling of the genitals, or if they experience even a slight fever of 100.4 degrees Fahrenheit.
The symptoms can worsen quickly, the agency said; so it’s important to get help right away.
Invokana lawsuits were previously filed over the drug’s increasing the risks of amputations. Invokana may also increase the risk of ketoacidosis, which is potentially fatal kidney failure. The U.S. FDA confirmed on May 16, 2017 that the Invokana label needed to include a black-box warning. The agency said the revised label must state that Invokana raises the risk of people needing to have their legs or feet amputated.
Invokana Linked to Amputations
A year earlier, on May 18, 2016, the FDA first announced Invokana and Invokamet were linked to amputations. FDA had announced May 15, 2015 that it was investigating reports of some type 2 diabetes drugs – including Invokana and Invokamet – for causing a serious medical condition known as ketoacidosis.
Invokana Flesh-Eating Infection Warning – Lawsuit Consultation
If you or someone you love suffered a flesh-eating genital infection following the use of Invokana, Farxiga, or Jardiance, contact our law firm for a free legal consultation regarding a potential diabetes drug lawsuit against the drug’s maker.