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Direct Healthcare Professional Communication (DHPC) on Alkindi® (hydrocortisone granules in capsules for opening): risk of acute adrenal insufficiency when switching from crushed or compounded oral hydrocortisone formulations
2021.02.04
Active substance: hydrocortisone
Diurnal Europe B.V. in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform about an adrenal crisis which has been reported in an infant who was switched from hydrocortisone soluble tablets to Alkindi® (hydrocortisone granules in capsules for opening). Acute adrenal insufficiency can occur when switching to Alkindi® granules due to a potential risk of inaccurate dosing possible with other oral hydrocortisone formulations, crushed or compounded.
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