SGLT-2 Information

Fourniers Gangrene Advice Leaflet

Why have I been given this information?

You have been given this leaflet because you are taking, or are about to take an SGLT-2 inhibitor drug to improve the treatment of your diabetes, chronic kidney disease or heart failure. The name of these drugs end with ‘gliflozin’, for example include empagliflozin (Jardiance®) dapagliflozin (Forxiga®) canagliflozin (lnvokana®), dapagliflozin (Forxiga®)

Some research has found that there are some very rare but important side effects which appear to be more common in patients taking these medications. It is important that you are aware of these potential side effects as if they are not identified early, can be extremely dangerous and life threatening.

What is this side effect?

Extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels around the genital area. This is a rare serious infection, called necrotizing fasciitis of the perineum (Necrosis meaning: body tissue is dead or is dying because of a lack of blood flow or a bacterial infection. In this case includes the testicles, penis, and the perineum which is the area between the scrotum and anus for a man; or the area between the anus and vulva for a woman) is also referred to as Fournier’s gangrene. If treatment is delayed it can be fatal. If you have any of these symptoms, please contact a medical professional, such as a doctor or nurse immediately, even if your blood sugars are near normal.

If we are closed, please call the NHS 111 service, by dialling 111, for more advice. Tell them that you are worried about one of the conditions mentioned above. You should stop this medication until you have sought further medical advice.

How common are these side effects?

Fournier’s gangrene can occur in people who do not have diabetes, but is more common in people with it. It is estimated to occur in approximately 1 in 100,000 patients treated with an SGLT-2 inhibitor. Most cases of Fournier’s gangrene occur in men, but in patients treated with SGLT2 inhibitors it can also occur in women.

What should I look out for?

The following symptoms might indicate Fournier’s gangrene: Tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F (38C) or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment straight away.

What if I am having major surgery?

Please stop this medication 24 hours before your surgery. Restart only after you are fully mobile and eating and drinking normally. If you are unsure what to do please contact us as above or 111 for further advice when we are closed.

If I feel unwell, what will my doctor or nurse do?

A blood test will test for the amount of glucose and ketones (a breakdown product of fat) in your blood. If your levels of ketones are high, you will likely require hospital treatment. If Fournier’s gangrene is suspected you will require prompt hospital treatment with antibiotics and surgery if necessary

Ketoacidosis Information

An increase of acid in the blood – SSGLT-2 inhibitors may cause certain acids (ketones) to build up in the blood. This is called diabetic ketoacidosis (DKA). This is a rare event but can happen even when your blood glucose is normal. Symptoms include nausea and vomiting, abdominal pain, rapid breathing, and dehydration e.g., dizziness and thirst. Sufferers’ breath smells like pear-drops/nail varnish remover.

The risk of DKA is increased if you do not eat for long periods, become dehydrated, reduce your insulin dose too quickly, drink excessive alcohol or are unwell. Please seek medical advice before starting any new diet particularly very low carbohydrate diets (also called ketogenic diets) as these can increase the ketones in the blood.

DKA is a serious health condition. If you believe you are developing symptoms of DKA then please seek urgent medical assessment reporting your concern and the medication you are taking.

Foot disease leading to toe or other amputation – if you have been told you have an “at risk foot” you should clarify with your doctor if you should start or remain on one of these medicines. If you have an active foot ulcer or problem with the blood supply in your leg, you should stop these medicines.