Brimonidine gel (Mirvaso): risk of systemic cardiovascular effects; not to be applied to damaged skin
Systemic cardiovascular effects including bradycardia, hypotension, and dizziness have been reported after application. It is important to avoid application to irritated or damaged skin, including after laser therapy.
Advice for healthcare professionals:
- cases of bradycardia, hypotension (including orthostatic hypotension), and dizziness after application of brimonidine gel have been reported, some of which required hospitalisation
- some cases were associated with application of brimonidine gel after laser procedures to the skin, which possibly caused increased absorption of the gel
- warn patients not to apply brimonidine gel to irritated or damaged skin, including after laser therapy to the skin
Brimonidine (Mirvaso) is a topical gel indicated for the symptomatic treatment of facial erythema of rosacea in adults. It is an α-2 adrenergic agonist.
A routine European review identified post-marketing reports, including a small number of Yellow Cards, consistent with systemic (central) α-2 adrenergic effects, including bradycardia, hypotension (including orthostatic hypotension), and dizziness. Some patients required hospitalisation. Dizziness is reported to occur uncommonly, with an estimated frequency of less than 10 in 1,000 patients using brimonidine gel. Hypotension and bradycardia are reported to occur rarely, with an estimated frequency of less than 1 in 1,000 patients.
In approximately 30% of the cases most strongly suggestive of a cardiovascular effect, events occurred following application of brimonidine gel after laser therapy to the skin.
To minimise the possibility of systemic absorption, you should warn patients not to apply brimonidine gel to irritated or damaged skin, including after laser therapy to the skin.
Any suspected adverse reactions to brimonidine gel or any other medicines should be reported to us on a Yellow Card.
Article citation: Drug Safety Update volume 10 issue 11, June 2017: 2.