Topical brimonidine (Mirvaso 3mg/g gel) is licenced for the symptomatic treatment of facial erythema of rosacea in adult patients.

Brimonidine is a highly selective α2 adrenergic receptor agonist. Topical application of brimonidine reduces facial redness by vasoconstriction of the cutaneous blood vessels.

A Drug Safety Update[1] was issued by MHRA in June 2017 advising of the risk of systemic cardiovascular effects following topical application of Mirvaso.

Systemic cardiovascular effects including bradycardia, hypotension (including orthostatic hypotension), and dizziness were identified following a European review of post-marketing reports. These cardiovascular effects are consistent with systemic α2 adrenergic activity. 

Approximately 30% of cases where cardiovascular effects were identified were associated with application of the gel following laser therapy to the skin.

In order to minimise systemic drug absorption patients should be advised not to apply brimonidine gel to irritated or damaged skin, including following laser therapy.

The Summary of Product Characteristics for Mirvaso advises that the gel should not be applied to irritated skin or open wounds.

The key advice for healthcare professionals can be summarised as:

  • Cases of bradycardia, 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
  • Patients should be warned not to apply brimonidine gel to irritated or damaged skin, including after laser therapy to the skin