Dapagliflozin (Forxiga0) is a renal sodium-glucose cotransport-er 2 inhibitor with, in particular, a glucose-lowering action (1,2). In 2019, dapagliflozin in the form of 5-mg tablets was authorised in the European Union for use in some adult patients with type 1 diabetes (3). In late 2021, the European Commission withdrew authorisation of dapagliflozin in this indication, following a request from the company, AstraZeneca, which markets the drug. The reasons for this withdrawal are not clearly set out in the European Commission document. However, the letter to healthcare professionals approved by the European Medicines Agency (EMA) mentions that diabetic ketoacidosis occurred in at least 1% of the patients included in clinical trials that evaluated dapagliflozin in type 1 diabetes. In patients with type 2 diabetes, the summary of product characteristics (SPC) for Forxiga0 refers to a frequency for this adverse effect of less than 1 case per 1000 treated patients (1,4). When Prescrire asked about the reasons for this withdrawal, the company explained that the EMA had requested particularly close monitoring for ketoacidosis in patients with type 1 diabetes, plus addition of the inverted blacktriangle to the SPC and patient information leaflet. The company preferred to withdraw the indication ratherthan add this symbol, which probably would have had a negative impact on its product in all its other indications (5).
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