The United States Food and Drug Administration (FDA) recently released a warning about adverse side-effects of a class of Type 2 diabetes drugs. The warning reported that in rare cases, taking the medications could result in a flesh-eating bacterial infection that attacks the genitals.
The condition is known as Fournier’s gangrene. It developed in around a dozen patients between March 2013 and May 2018 since they started taking the medications, according to the FDA. Seven men and five women were subsequently hospitalized and received surgery for the infection. One of the patients later died.
The FDA believes that there may be more cases of Fournier’s gangrene and released a statement about it. Its warning includes diabetes drugs Invokana by Johnson and Johnson, Jardiance by Eli Lilly and Co. and Faxiga by AstraZeneca. The medications are all SGLT2 inhibitors that were approved in 2013 and 2016 and are meant to treat diabetes by lowering blood sugar levels and ensure that excess sugar is eliminated in the individual’s urine. One side effect that was known at the time of their release is urinary tract infections (UTIs).
Compared with these findings, the FDA only found six cases of the serious condition in individuals taking all other classes of diabetes drugs in the past 30 years. Those six cases were all found in men.
The class of drugs is projected to amass as much as $7.1 billion in sales by 2010, according to Bloomberg Intelligence, and the FDA estimated that 1.7 million people received a prescription for one medication or another from retail pharmacies in 2017. This seems to stress the rarity of Fournier’s gangrene, which is also known as necrotizing fasciitis.
The condition is an infection that affects the tissue under the skin surrounding muscles, nerves, fat and blood vessels around the perineum. In circumstances other than taking these drugs, bacteria would enter the body through a cut or break in the skin.
According to the FDA, Fournier’s gangrene typically occurs in males between the ages of 50 and 79. It tends to affect 1.6 out of 100,000 men each year. The FDA states that diabetes is a risk factor for developing the condition and that anyone experiencing symptoms of redness, tenderness or swelling in the genital area to the back of the rectum, a fever over 100.4 Fahrenheit and feeling unwell should seek immediate medical attention. The agency stressed that the symptoms have the ability to quickly worsen, which means immediate treatment is absolutely essential.
Now the FDA is making it a requirement for drug manufacturers to include information about the risk of the disease in both medication guides and prescribing information to warn patients.
Overall, the only drug within the class that is not linked to Fournier’s gangrene is Steglujan, which is manufactured by Merck and Co.
The FDA issued a statement saying that medical professionals should assess patients for the disease if they exhibit any of the symptoms mentioned above and that anyone believed to have Fournier’s gangrene should be immediately treated with antibiotics and surgery if needed. The FDA further said that the SGLT2 inhibitor should immediately be discontinued and the patient’s blood glucose levels should be closely monitored while an alternative treatment is sought.
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