The US Food and Drug Administration has begun warning doctors and patients against some popular diabetes medication, because of the rare possibility that these may cause a flesh-eating bacterial infection in patient’s genitals.
The side effect, a condition known as Fournier’s gangrene, has developed in a dozen patients so far, with one case resulting in death. Symptoms began manifesting shortly after the patients began taking medication to address their diabetes. The reported cases occurred between March 2013 and May 2018, according to the US FDA. Seven men and five women were hospitalized as a result and had to undergo surgery to combat the disease.
The US FDA said in a statement that the dozen patient record may be conservative, as more cases could be uncovered through further investigation into the risks involved with the drugs.
The drugs covered by the FDA-issued warning include Johnson & Johnson’s Invokana, AstraZeneca Plc’s Farxiga and Eli Lilly &Co’s Jardiance. The drugs were approved by the US FDA is 2013, 2013, and 2016, respectively. If you or anyone you know if currently taking these prescriptions, you may need to consult your doctor.
The drugs in question effectively work to address diabetic concerns by helping the body lower blood-sugar levels via the kidneys. Excess sugar is excreted in a patient’s urine. This form of sugar voiding makes patient’s prone to urinary tract infections.
For a comparison, the incident of Fournier’s gangrene recorded by the US FDA for all other classes of diabetes medication was six cases, all in men, over the last three decades.
The US FDA estimates that about 1.7 million pateints were prescribed the drugs in question from an American retail pharmacy in 2017, which underscores how rare the condition is.
However, all the drugs in this particular class of diabetes medication, with the exception of the most recently approved Steglujan (manufactured by Merck & Co), have been solidly linked to the condition. The US FDA has said that mnaufacturers will have to revise the information they release about the drugs to include warnings of the risk these prescriptions carry.
AstraZeneca has said it is currently working to revise its labels.