Other safety alerts
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| The United Kingdom: Brimonidine gel (Mirvaso): risk of systemic cardiovascular effects; not to be applied to damaged skin |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announces that systemic cardiovascular effects including bradycardia, hypotension, and dizziness have been reported after application of brimonidine gel. 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 1000 patients using brimonidine gel. Hypotension and bradycardia are reported to occur rarely, with an estimated frequency of less than 1 in 1000 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.
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.
Healthcare professionals are advised:
- cases of bradycardia, hypotension (including orthostatic hypotension), and dizziness after application of brimonidine gel have been reported, some of which required hospitalization;
- some cases were associated with application of brimonidine gel after laser procedures to the skin, which possibly caused increased absorption of the gel; and
- to warn patients not to apply brimonidine gel to irritated or damaged skin, including after laser therapy to the skin.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/brimonidine-gel-mirvaso-risk-of-systemic-cardiovascular-effects-not-to-be-applied-to-damaged-skin
In Hong Kong, Mirvaso Gel 0.33% (HK-63413) is a pharmaceutical product containing brimonidine. The product is registered by Galderma Hong Kong Limited, and is a prescription only medicine. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to brimonidine. In light of the above MHRA's announcement, letters to inform local healthcare professionals to draw their attention on the risks will be issued. DH will remain vigilant on safety update of the product and any change in product information issued by overseas drug regulatory authorities.
Ends/Thursday, Jun 22, 2017
Issued at HKT 14:00
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