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 U.S. health regulator has also called for including this risk in the drugs’ labeling.

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.

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