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Friday, 31 August 2018

FDA warns of serious genital infection linked to SGLT2 inhibitors

It was Graham that first spotted this article … 

(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 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.

The companies did not immediately respond to Reuters request for comment.

Patients are at risk of the infection known as Fournier’s gangrene, an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds the genital area, the FDA said in a statement.

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.

One patient died, while some required multiple disfiguring surgeries and developed complications, the agency said.

The infection developed within several months of the patients starting an SGLT2 inhibitor and the drug was stopped in most cases, the FDA said.

Other serious side effects include:

Graham says, "I think I'll stick with low carb where in most T2 diabetics the need for these drugs is eliminated"

Eddie says, "Readers may like to read this blogs 'Introduction to low-carb for beginners' post" - find it here

All the best Jan, Eddie and Graham
         (The Low Carb Team)


Elephant's Child said...

That is downright terrifying.
'Trust me, I am a doctor'.

Anonymous said...

C'est terrible, il vous fait vous demander ce que le dépistage des drogues a été effectivement fait.

Monique Chailez

DMS said...

It is always awful when medications which have been prescribed to help actually cause terrible damage.

Mary Kirkland said...

Oh that doesn't sound good at all.

Valerie-Jael said...

Sounds awful, that's a drug nobody needs. Hugs, Valerie

Linda said...

I saw that today and checked my husband's Rx list. Yep, his new diabetes med is on the list of SGLT2 inhibitors. He called his doctor but has not had a call back yet.

Lowcarb team member said...

Monique Chailez said:
"C'est terrible, il vous fait vous demander ce que le dépistage des drogues a été effectivement fait."

Google translate:
That's terrible, it makes you wonder what drug testing was actually done.

Many thanks for your comment Monique,
I do not know what drug testing was done but you may be interested in reading this article about, 'How Drugs are Developed and Approved' see it here

All the best Jan

Teresa said...

Muy interesante reportaje. Saludos.

William Kendall said...

Very troubling.

Amy Purdy said...

That's scary!

carol l mckenna said...

Thanks for posting this ~ not just diabetic medication but physicians all too quick to hand out meds ~

Happy Day to you,
A ShutterBug Explores

Magic Love Crow said...

This is horrible!