PRAC concludes evaluation of risk of acute adrenal insufficiency in children when switching to Alkindi (hydrocortisone) granules

PRAC advises that a healthcare professional letter should advise doctors to counsel carers to observe for symptoms of adrenal insufficiency during first week after switching to Alkindi & increase the dose of Alkindi granules if the child develops symptoms of adrenal insufficiency

SPS commentary:

The safety review followed a case report of a baby developing severe adrenal insufficiency after switching from hydrocortisone soluble tablets to Alkindi granules.

Drug Safety