(Reuters) – The U.S. Food and Drug Administration (FDA) said on Wednesday a serious genital infection has been reported in patients taking a certain class of diabetes drugs, with one death and 11 others hospitalized.
The warning pertains to a class of medicines called SGLT2 inhibitors, first approved in 2013 to lower blood sugar in adults with type 2 diabetes.
The SGLT2 inhibitors approved by the FDA include Johnson & Johnson’s Invokana, Eli Lilly & Co’s Jardiance, as well those from Bristol-Myers Squibb, Astra Zeneca Plc, Merck & Co and Pfizer Inc.
The companies did not immediately respond to Reuters request for comment.
The bacteria usually enter the body through a cut and quickly spread. Having diabetes is a risk factor for developing Fournier’s gangrene.
The FDA said it identified 12 cases of Fournier’s gangrene – 7 in men and 5 in women – between March 2013 and May 2018.
The infection developed within several months of the patients starting an SGLT2 inhibitor and the drug was stopped in most cases, the FDA said.
AUGUST 30, 2018