UK Health Regulator warns about Mirvaso and cardiovascular effects

Written by on August 8, 2018 in Mirvaso Gel (Brimonidine 0.33%) with 0 Comments

 

yellow-card-mhra

The regulator of healthcare products in the UK has issued a Drug Safety Update related to the topical treatment for the red face of rosacea – Mirvaso. This update was issued in June 2017 and seems to have gone largely unnoticed by rosacea sufferers online.

Here is why it has been issued, and what you need to know.

Who is the MHRA?

The Medicines and Healthcare products Regulatory Agency in the UK is responsible for the control of all medicines and medical devices – for making sure that they are safe and effective.

The MHRA issued a Drug Safety Update for Mirvaso based on information that has been received from users of Mirvaso that have experienced adverse events. These reports originate from Post Marketing Reports – notes from users who have filled in `yellow cards’. Any user of Mirvaso in the UK, and indeed any health professional can file a Yellow Card to inform the MHRA of an adverse event.

Similarly, users of Mirvaso in the United States who experience an adverse event can also advise the FDA.

Of particular concern in this Drug Safety Update is the mention of systemic cardiovascular effects. The effects originate from the systemic absorption of brimonidine from the topical application of Mirvaso into the blood stream, where bradycardia, hypotension and dizziness have been reported.

What should I do?

The Drug Safety Update directs health care professionals to be aware of the existence of the advice and to advise their patients to show care when applying Mirvaso to irritated or damaged skin. A specific mention is made of skin post laser treatment – that Mirvaso should be used with care here. So here is some good advice – be very careful if you plan to use Mirvaso to help recover from any redness as a result of undergoing laser therapy.

Did Galderma warn us?

Actually, yes Galderma have mentioned these warnings in the Prescribing Information for Mirvaso.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of MIRVASO topical gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.

  • Cardiovascular disorders: bradycardia, hypotension (including orthostatic hypotension)
  • Immune system disorders: angioedema, hypersensitivity, lip swelling, swollen tongue, throat tightness, urticaria
  • Nervous system disorders: dizziness
  • Skin and subcutaneous disorders: pallor

and further

Systemic Adverse Reactions of Alpha-2 adrenergic agonists

Postmarketing cases of bradycardia, hypotension (including orthostatic hypotension) and dizziness have been reported. Some cases required hospitalization. Some cases involved application of MIRVASO topical gel in unapproved dosing regimens and for unapproved indications, including the application of MIRVASO topical gel following laser procedures. Avoid applying MIRVASO topical gel to irritated skin or open wounds.

What about Rhofade?

This risk arrives after some laboratory research has suggested that Mirvaso’s competing redness treatment, oxymetazoline based Rhofade may be capable of damaging heart valves – so called valvulopathy.

So this confirms again that drugs do come with side effects. Be careful out there.

Mirvaso Yellow Card

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.

Published 21 June 2017

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.

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About the Author

About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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