SGLT2 and diabetic ketoacidosis risk among MHRA drug safety updates
April 20 2016
Patients taking sodium-glucose co-transporter 2 (SGLT2) inhibitors (canagliflozin, dapagliflozin, or empagliflozin) need to be told about diabetic ketoacidosis, the medicines regulator has said.
Patients taking the drugs to improve glycaemic control in diabetes should be informed about the signs and symptoms of diabetic ketoacidosis (DKA), and advised to seek immediate medical advice if they develop them.
In addition, health professionals should:
- discuss the risk factors for DKA with patients;
- discontinue treatment with the SGLT2 inhibitor immediately if DKA is suspected or diagnosed;
- not restart treatment with any SGLT2 inhibitor in patients who experienced DKA during use, unless another cause for DKA was identified and resolved;
- interrupt treatment with the SGLT2 inhibitor in patients who are hospitalised for major surgery or acute serious illnesses; treatment may be restarted once the patient’s condition has stabilised;
- report suspected side effects to SGLT2 inhibitors or any other medicines on a Yellow Card.
The advice was issued following reviews of the side effect, which is considered rare: by the end of February, the MHRA has received 118 yellow Card reports of DKA in association with an SGLT2 inhibitor. While SGLT2 inhibitors are indicated for type 2 diabetes, a number of DKA cases have been reported where the use was off-label in type 1 diabetes.
“In several cases, blood glucose levels were only moderately elevated (eg <14mmol/L)—representing an atypical presentation for DKA, which could delay diagnosis and treatment,” noted the MHRA.
“Therefore inform patients of the signs and symptoms of DKA (eg rapid weight loss, feeling sick or being sick, stomach pain, fast and deep breathing, sleepiness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat) and test for raised ketones in patients with these signs and symptoms.”
The advisory is one of a number of Drug Safety Updates issued by the medicines regulator, the MHRA, this week.
A second DSU gave advice around minimising the risk of cardiac side effects for patients taking apomorphine concomitantly with domperidone, saying patients should be monitored regularly and be aware of changes that could increase arrhythmia risk.
- symptoms of cardiac or hepatic disorder
- changes to electrolyte levels, such as due to diarrhoea or starting a diuretic
- starting any other medicines
Another DSU has highlighted the fire risk of smoking or using a naked flame when a patient is using paraffin-based skin emollients. “We are aware of a recent fatal incident reported to the NHS England National Reporting and Learning System, in which a naked flame ignited emollient in contact with a patient’s dressings and clothing,” said the MHRA.
Among the other DSU advisories were that as meprobamate is being withdrawn from the market at the end of 2016, prescribers should be reviewing patients being treated with meprabomate for anxiety states or musculoskeletal disorders. Existing patients should be switched to an alternative, and no new patients should be started on meprobamate.