Advice for healthcare professionals
- hydrocortisone muco-adhesive buccal tablets are indicated only for local use in the mouth for aphthous ulceration and should not be used for treating adrenal insufficiency
- substitution of licensed oral formulations of hydrocortisone with muco-adhesive buccal tablets can result in insufficient cortisol absorption and, in stress situations, life-threatening adrenal crisis
- prescribers and pharmacists should only consider use of licensed hydrocortisone products for adrenal replacement therapy
- report suspected adverse drug reactions, including medication errors resulting in harm, on a Yellow Card
Reports of off-label use in the UK
We have received Yellow Card reports of off-label use of hydrocortisone muco-adhesive buccal tablets for adrenal insufficiency in children in the UK. The reports raised concerns about possible aggravation of congenital adrenal hyperplasia following substitution with muco-adhesive buccal tablets.
Hydrocortisone muco-adhesive buccal tablets are indicated only for local use in the mouth for aphthous ulceration (mouth ulcers). The efficacy and safety of hydrocortisone buccal tablets to treat adrenal insufficiency have not been established. Suspected adverse event reports indicate that the buccal hydrocortisone tablets provide decreased cortisol release compared with conventional oral tablets. If muco-adhesive buccal tablets are prescribed as a substitute for adrenal replacement therapy, there is the risk of insufficient cortisol release and, in stress situations, life-threatening adrenal crisis.
There are oral formulations of hydrocortisone authorised for the treatment of adrenal insufficiency. Prescribers and pharmacists should only use of these licensed hydrocortisone products for this condition.
The product information of the hydrocortisone muco-adhesive buccal tablets is being updated with warnings about the serious risks associated with off-label use for the treatment of adrenal insufficiency.
Report suspected adverse drug reactions on a Yellow Card
Suspected adverse drug reactions to hydrocortisone should be reported to the Yellow Card Scheme, including those that may be related to off-label use or medication error resulting in harm. Please don’t assume someone else will report an adverse drug reaction you witness – if in doubt report a Yellow Card.
For more about how you can support the Yellow Card Scheme in improving the safety of medicines in children, see November 2018 Drug Safety Update.
Article citation: Drug Safety Update volume 12, issue 5: December 2018: 5.
Published 18 December 2018