Other safety alerts
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| European Union: PRAC concludes evaluation of risk of acute adrenal insufficiency in children when switching to Alkindi |
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European Medicines Agency (EMA) announces that it’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC) evaluated a safety signal regarding the risk of acute adrenal insufficiency that may occur in children when switching from conventional oral hydrocortisone formulations to Alkindi granules, due to potential inaccurate dosing with other oral hydrocortisone formulations, crushed or compounded.
Alkindi, available as capsules containing granules, is a medicine for children (from birth to up to 18 years of age) whose adrenal glands cannot make enough of a hormone called cortisol.
This review was triggered by a case report of a baby developing severe adrenal insufficiency after switching from hydrocortisone soluble tablets to Alkindi granules.
Following a careful evaluation of the provided data, the PRAC recommended actions to minimise the risk.
These include a direct healthcare professional communication letter (DHPC), which warns doctors that carers should carefully observe the child for symptoms of adrenal insufficiency such as tiredness, headache, unstable temperature and vomiting during the first week after switching to Alkindi. Doctors should advise carers to increase the doses of Alkindi granules if the child develops symptoms of adrenal insufficiency, as recommended in the product information, and seek immediate medical attention.
As Alkindi is a centrally authorised medicine, the DHPC will now be sent to EMA’s human medicines committee (CHMP) for a final opinion.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-11-14-january-2021
Local Situation in Hong Kong: In Hong Kong, Alkindi is not a registered pharmaceutical product.
Ends/ Saturday, Jan 16, 2021
Issued at HKT 12:00
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