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A class of diabetes drugs result in flesh eating genital infection : US FDA issues warning

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A class of diabetes drugs result in flesh eating genital infection : US FDA issues warning

Popularly prescribed drugs for diabetes have now been reported to cause rare, life-threatening, flesh-eating genital infection. The US FDA warned that this resulted in a fatality in one case, while eleven others have been hospitalized and are undergoing surgery.

The class of drugs, sodium-glucose cotransporter-2 (SGLT2) inhibitors, known by popular brand names including Johnson & Johnson’s Invokana, Eli Lilly & Co.’s Jardiance and AstraZeneca Plc’s Farxiga are used in treatment of Type 2 diabetes. The infection known in medical circles as Fournier’s gangrene results in a condition described as ‘necrotizing fasciitis’ and is known to have a mortality rate of 20%. The FDA stated that the bacteria enters the body via cuts or breaks in the skin, resulting in infection that spreads fast, destroying tissues.

The reasons for the warning are the comparatively high incidence of the rare infection among users of these drugs and infection levels among users of other drugs in the last three decades. In a period spanning 5 years, beginning in March 2013, the drugs resulted in 12 cases, whereas in the case of other drugs spanning 30 years, there have been only six known instances. The US FDA warned patients to be alert for symptoms that included swelling of the genitals, tenderness, and redness in the area of the genitals, including up to the rectum. Fever that crosses 100.4 F also needs to be a cause for seeking medical attention among patients on this class of drugs. The agency advised patients to seek medical assistance quickly, as the symptoms are known to manifest and aggravate very fast.

These inhibitors were approved by the FDA five years ago and in the last year alone, more than 1.7 million patients received a prescription for the drugs. The number of cases recorded against the number of prescriptions is an indication of the rare condition linked to the drug. The drug helps in the reduction of blood sugar levels through the kidneys, with the excess sugar flushed through the urine of patients. One of the known side effects of the drug has been urinary tract infections.

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