27.3.20: Briefing from the European Medicines Agency
EMA reports that it is aware of recent media reports and publications which
question whether some medicines, for instance angiotensin converting
enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or
sartan medicines), could worsen coronavirus disease (COVID-19).
ACE inhibitors and ARBs are most commonly used for treating patients
with high blood pressure, heart failure or kidney disease.
The EMA has providing the following advice from its Public and Stakeholders Engagement Department.
"It
is important that patients do not interrupt their treatment with ACE
inhibitors or ARBs and there is no need to switch to other medicines.
There is currently no evidence from clinical or epidemiological studies
that establishes a link between ACE inhibitors or ARBs and the worsening
of COVID-19. Experts in the treatment of heart and blood pressure
disorders, including the European Society of Cardiology, have already
issued statements along those lines. To gather more evidence, EMA is
proactively reaching out to researchers working to generate further
evidence in epidemiological studies.
As
the public health crisis rapidly extends across the globe, scientific
research is ongoing to understand how the severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) reproduces in the body, interacts
with the immune system and causes disease, and whether ongoing treatment
with medicines such as ACE-inhibitors and ARBs could impact the
prognosis of COVID-19.
The
speculation that ACE-inhibitors or ARBs treatment can make infections
worse in the context of COVID-19 is not supported by clinical evidence.
These medicines work by affecting the renin-angiotensin-aldosterone
system (RAAS). Because the virus uses a target called angiotensin
converting enzyme 2 (ACE2), which is part of this system, to enter human
cells, and the medicines can increase ACE2, one of the suggestions
among others is that they could also increase virus activity. However,
the interactions of the virus with the RAAS in the body are complex and
not completely understood.
EMA
is monitoring the situation closely and is collaborating with
stakeholders to coordinate epidemiological studies on the effects of ACE
inhibitors and ARBs in people with COVID-19.
EMA
is helping to coordinate urgent ongoing research and is fully committed
to keep the public up to date with any development in this field. EMA
is also aware of reports questioning whether other medicines such as
corticosteroids and non-steroidal anti-inflammatories (NSAIDs) could worsen COVID-19, and has recently issued a communication on NSAIDs medicines.
It is important that patients who have any questions or are uncertain
about their medicines speak to their doctor or pharmacist and do not
stop their regular treatment without speaking to their healthcare
professional first.
Medicines
should be prescribed and used in line with clinical judgement, taking
due note of any warnings and other information provided in the summary of product characteristics (SmPC) and thepackage leaflet, as well as guidance issued by the WHO and relevant national and international bodies.
Within
the EU medicines regulatory network, evidence on the safe use of
medicines is reviewed as it emerges. Any new advice that arises is
disseminated appropriately through EMA and national competent authorities.
EMA will provide further information as appropriate.
