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MHRA publish warning for SGLT2 inhibitors: reports of Fournier’s gangrene

For Type 1 diabetes and Type 2 diabetes

The Medicines and Healthcare products Regulatory Agency (MHRA) have published a warning for all medicines in the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors.

This class of medicines is used in the treatment of diabetes and the following medicines are affected (with brand names):
  • canagliflozin - Invokana and Vokanamet▼
  • dapagliflozin - Forxiga, Qtern, Edistride, Ebymect and Xigduo
  • empagliflozin - Jardiance, Glyxambi▼ and Synjardy▼
  • ertugliflozin - Steglatro▼, Segluromet▼ and Steglujan▼
The new warning relates to 6 reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum).

Necrotising fasciitis is a rare but serious bacterial infection that affects the tissue beneath the skin and surrounding muscles and organs (fascia).

It's sometimes called the "flesh-eating disease", although the bacteria that cause it do not "eat" flesh, but release toxins that damage nearby tissue.

Necrotising fasciitis can start from a relatively minor injury, such as a small cut, but gets worse very quickly and can be life threatening if it's not recognised and treated early on.

The symptoms of necrotising fasciitis develop quickly over hours or days.

They may not be obvious at first and can be similar to less serious conditions, such as flu, gastroenteritis or cellulitis.

Early symptoms can include:
  • a small but painful cut or scratch on the skin
  • intense pain that's out of proportion to any damage to the skin
  • a high temperature (fever) and other flu-like symptoms
After a few hours to days, you may develop:
  • swelling and redness in the painful area – the swelling will usually feel firm to the touch
  • diarrhoea and vomiting
  • dark blotches on the skin that turn into fluid-filled blisters
If left untreated, the infection can spread quickly through the body and cause symptoms such as dizziness, weakness and confusion.

When to get medical help
Necrotising fasciitis is a medical emergency that requires immediate treatment.

Go to your nearest A&E department as soon as possible if you think you have it.

Call 999 for an ambulance if you're too unwell to get yourself to A&E.

You can follow developments with this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.



The MHRA has published the following advice for healthcare professionals:
  • post-marketing cases of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) have been associated with the use of sodium-glucose co-transporter 2 (SGLT2) inhibitors
  • Fournier’s gangrene is a rare but serious and potentially life-threatening infection
  • if Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and urgently start treatment (including antibiotics and surgical debridement as required)
  • urogenital infection or perineal abscess may precede necrotising fasciitis
  • advise patients to seek urgent medical attention if they experience severe pain, tenderness, erythema, or swelling in the genital or perineal area, accompanied by fever or malaise
  • report suspected adverse drug reactions to a SGLT2 inhibitor to the Yellow Card Scheme without delay

Sources
MHRA website
NHS website for necrotising fasciitis
Contains public sector information licensed under the Open Government Licence v3.0.
Accessed 01/05/19
Links available in full article

MHRA information on SGLT2 inhibitors

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.


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