By Pam Brown, Editor-in-Chief, Diabetes & Primary Care
The European Medicines Agency (EMA) have again highlighted the possible risk of lower limb amputation (mainly toes) with sodium–glucose cotransporter 2 (SGLT2) inhibitors, advice reiterated in the recent MHRA Safety Update. Healthcare professionals are encouraged to remind people taking these drugs to check their feet regularly, follow preventive care, and report any wounds or discolouration or if their feet are tender or painful. The EMA states that an increased risk has not been seen in studies with other medicines in the same class, dapagliflozin and empagliflozin. However, data available to date are limited and the risk may also apply to these other medicines. The product information for the three drugs in the class will be revised to include a warning of possible increased risk. No changes to prescribing are recommended. The prescribing information for canagliflozin will also include lower limb amputation as an uncommon side effect (occurring in <10 patients per 1000). Healthcare professionals are advised to carefully monitor people receiving canagliflozin who have risk factors for amputation, such as poor control or problems with heart or blood vessels, and to consider stopping canagliflozin if patients develop foot complications such as infection, skin ulcers, osteomyelitis or gangrene. After consideration of outcomes in the CANVAS study where the amputation risk was identified, the EMA recommended the study should continue.
Access the EMA announcement here, and the MHRA Safety Update here.
