Safety signal (Risk of acute adrenal insufficiency) Hydrocortisone
Safety signal (Risk of acute adrenal insufficiency) Hydrocortisone
European Medicines Agency (EMA) has published Direct healthcare professional communications (DHPC) regarding the Risk of acute adrenal insufficiency when switching from crushed or compounded oral hydrocortisone formulations to Alkindi (hydrocortisone granules in capsules for opening)
Key facts of DHPC
| Medicine name | Alkindi |
| Active substance | Hydrocortisone |
| Therapeutic area (MeSH) | Adrenal Insufficiency |
| DHPC type | Safety signal |
| Date Dissemination | 04 Feb 2021 |
Safety signal (Risk of acute adrenal insufficiency) Hydrocortisone – DHPC Communication
| Medicinal product(s)/active substance(s) | Alkindi (hydrocortisone granules in capsules for opening)/ Hydrocortisone |
| Safety concern and purpose of the communication | Risk of acute adrenal insufficiency when switching from oral hydrocortisone formulations, crushed or compounded, to Alkindi |
| DHPC recipients | Paediatric and adult endocrinologists.
The target group should be further defined at national level, in agreement with the respective national competent authority. |
| Member States where the DHPC will be distributed | All EU member states where Alkindi is marketed. |
Source from EMA site
To know more information, click here.
https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-risk-acute-adrenal-insufficiency-when-switching_en.pdf
Drug Safety Alerts UK MHRA (November 2020)
