New age SGLT2 diabetes drugs may cause flesh-eating genital infection

By PharmaCompass

2018-09-06

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The US Food and Drug Administration (FDA) has warned doctors and patients that some widely used diabetes drugs may, in some rare cases, cause a flesh-eating bacterial infection of the genitals, known as Fournier’s gangrene.

The drugs covered by the warning include Johnson & Johnson’s Invokana, AstraZeneca Plc’s Farxiga and Eli Lilly’s Jardiance. These are comparatively new drugs, launched between 2013 and 2016. A total of 13 SGLT2 drugs will need this new warning.

The SGLT2 drugs help the body lower blood-sugar levels via the kidneys, and excess sugar is excreted through the patient’s urine. Urinary tract infections are a known side effect of these drugs.

A dozen patients developed Fournier’s gangrene shortly after they began taking the medicines between March 2013 and May 2018, the FDA said. The seven men and five women were all hospitalized and underwent surgery for the condition. One patient died.

More cases may be uncovered once the risk is better understood, the FDA said in a statement.

In comparison, the FDA found only six cases of this condition, all in men, in a review of all other diabetes drug classes that it had examined for the past three decades.

All SGLT2 drugs have been linked to cases of Fournier’s gangrene, except Merck’s Steglatro (ertugliflozin), which was approved late last year. But that product will also need to carry the warning, the FDA said in its announcement.

According to the FDA, diabetics using the drugs should seek immediate medical attention if they develop tenderness, redness or swelling of the genitals, or even if they have mild fever. The symptoms can worsen quickly, so it’s important to get help immediately, the FDA said.

This is not the first time SGLT2 inhibitors have been in news. In May 2015, SGLT2 inhibitors — canagliflozin, dapagliflozin, and empagliflozin — were served a deadly blow as the FDA issued a safety warning regarding their use, leading to a potential life-threatening condition.

The FDA warning had said “type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition, where the body produces high levels of blood acids called ketones that may require hospitalization”.

Similarly, in June last year, PharmaCompass had carried news on how Johnson & Johnson's Invokana decreases the risk of heart attacks and strokes, but increases the risk of amputation, particularly of toes.

Nearly 2 million patients filled prescriptions for SGLT2 inhibitors in 2017, according to the FDA. And Bloomberg expects these drugs to generate US$ 7 billion in combined sales by 2020.

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“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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