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Translation of a-t 2019; 50: 63
 

CURRENT ADR NETWORK REPORT

Empagliflozin (JARDIANCE)-induced generalised pruritus

A 75 year-old man with type 2 diabetes complained of full-body pruritus, oral thrush and fungal infection of the glans penis after taking empagliflozin (JARDIANCE, a-t 2014; 45: 75) for one year. The symptoms improved after the SGLT-2 inhibitor was discontinued. The same symptoms had already occurred before, also after one year of treatment with the antidiabetic agent (NETZWERK report 17.604). The internist filing the report describes another female patient who presented with persistent, unpleasant pruritus following prescription of empagliflozin. The symptoms resolved only after the treatment had been discontinued (17.641). In the empagliflozin Summary of Product Characteristics (SPC), "pruritus (generalised)" is mentioned as a common adverse reaction (1). For the SGLT-2 inhibitor canagliflozin (no longer commercially available in Germany: INVOKANA; a-t 2014; 45: 45-7), there is a published case report of intensive, generalised pruritus with remission occurring within 20 days of treatment withdrawal (2). Overall, the WHO Adverse Drug Reaction Database lists approximately 100 events involving generalised pruritus reported in conjunction with the derivatives canagliflozin, dapagliflozin (FORXIGA; a t 2013; 44: 1-3, see also page 57) and empagliflozin (3). Pruritus, which is generally deemed clinically harmless, can considerably reduce quality of life. Therefore, a trial withdrawal period should be considered if a drug-induced reaction is suspected.

1Boehringer Ingelheim/Lilly: JARDIANCE SPC, as at Feb. 2019
2VASAPOLLO, P. et al.: Curr. Drug Saf. 2018; 13: 38-40
3WHO: VigiBase, accessed July 2019; http://www.vigiaccess.org

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