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Danish Medicines Agency investigating dangerous side-effect of diabetes drugs

Upon a warning from FDA, the Danish Medicines Agency and EMA are currently investigating whether SGLT2 inhibitors have caused infections with carnivorous bacteria in the genitals of European patients.

Foto: /ritzau/Esben Salling

To the Danish Medicines Agency, it was a novelty when the US Food and Drug Administration (FDA) last week issued a warning that a class of diabetes drugs, SGLT2 inhibitors, have caused highly dangerous infections with carnivorous bacteria in the genitals of 12 US patients.

"There were no red flags in the European side-effect database. In Europe, there has been no sign of a sudden rise in these reported side-effects. The first we see is the FDA warning," says Doris Stenver, Chief Medical Officer in Danish Medicines Agency and member of the Pharmacovigilance Risk Assessment Committee at European Medicines Agency (EMA).

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