MHRA Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued safety alerts associated with the use of SGLT2 inhibitors (dapagliflozin, empagliflozin, canagliflozin or ertugliflozin):

Fournier’s gangrene

• Fournier’s gangrene is a rapidly progressing, tissue-destroying infection on the genitals and nearby which is rare but potentially life-threatening.
• It commonly occurs in older men, but it can also occur in women and children.
• Seek urgent medical attention if you experience severe pain, tenderness, redness/blackening of the skin, or swelling in the genital or perineal area, accompanied by fever or feeling unwell.
• If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor immediately and seek medical advice.
• Link for more information: Fournier Gangrene: Causes, Symptoms, Treatment, Prevention

Diabetic Ketoacidosis (DKA) > applicable if you have a diagnosis of diabetes.

• DKA is a complication of diabetes that results from increased levels of a chemical called ketones in the blood.
• Seek urgent medical attention if you experience excessive thirst, frequent urination, fatigue, and /or vomiting.
• Risk factors for DKA include a low beta cell function reserve, conditions leading to restricted food intake or severe dehydration, sudden reduction in insulin, increased insulin requirements due to acute illness, recent surgery or alcohol abuse.
• Discontinue treatment with the SGLT2 inhibitor immediately if DKA is suspected.
• Link for more information: Diabetic ketoacidosis - NHS (www.nhs.uk)

Increased risk of lower-limb amputation > applicable if you have a diagnosis of diabetes and are taking canagliflozin only.

• Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes.
• Seek medical attention if you experience foot complications such as infection, skin ulcers, osteomyelitis, gangrene, local swelling or pain, reddening of the skin or discharge.
• Risk factors include poor control of diabetes and problems with the heart and blood vessels.
• Maintain adequate hydration and ensure you have a foot check in primary care at diagnosis and at least once a year thereafter, or sooner if any foot problems arise. This will be included in your annual diabetes review with one of our nurses.

If you have any queries or would like more information, please get in touch and make an appointment with our Diabetes Nurse or a clinical pharmacist.