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The authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus. The removal of the type 1 diabetes indication is not due to any new safety concerns and the other indications of dapagliflozin are unchanged.
You may need to tell DVLA if you have diabetes, depending on the treatment you're getting
Test for raised ketones in patients with acidosis symptoms, even if plasma glucose levels are near-normal.
If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and start treatment urgently (including antibiotics and surgical debridement). Fournier’s gangrene is a rare but potentially life-threatening infection that requires urgent medical attention.
Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes. Evidence does not show an increased risk for dapagliflozin and empagliflozin, but the risk may be a class effect. Preventive foot care is important...
Test for raised ketones in patients with ketoacidosis symptoms, even if plasma glucose levels are near-normal.
Check what side effects people have reported when they've taken a medicine.
SGLT2 inhibitor treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses and ketone levels measured, preferably in blood rather than urine. Treatment may be restarted when the ketone values are normal...
Advice for medical professionals to follow when assessing drivers with diabetes mellitus.
Find drug safety updates issued by MHRA
Further information on what drivers with different types of diabetes need to tell DVLA by law.
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
Report diabetes treated with Sulphonylureas or Glinide tablets to DVLA if you're a lorry, bus or coach driver.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Orifarm UK has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged within the parallel import packs of the specific batches of Concerta XL 18mg and 36mg prolonged release tablets mentioned in this notification.
Atnahs Pharma UK Ltd has informed the MHRA that the batches of Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension listed in this notification do not contain the most up to date safety information.
medac GmbH (t/a medac Pharma LLP) is recalling further batches due to particles detected during long-term stability tests.
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