From the European Medicines Agency. Ask your doctor.
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Omega-3 fatty acid medicines no longer considered effective in preventing heart disease
EMA has concluded that omega-3 fatty acid medicines are not effective in preventing further
heart and
blood vessel
s problems
in patients who have had a heart attack
. The conclusion, based on a review of
data
accumulated over the years, means that these medicines will
use.
Omega
-3 fatty acid medicines have been authorised
for
use after a heart attack, in combination with
other medicines,
in several
EU countries since
2000, at a
dose of 1 g
per
day
. At the time of their
authorisation
, available data showed some benefits in reducing serious problems with the heart and
blood vessels
, although the benefits were considered modest
. Further data
that have become available
since then have not confirmed the beneficial effects
of these medicines
for this use
.
Although there are no new
safety concerns, EMA’s human medicines committee (CHMP) concluded that
the balance between the benefits and risks of these medicines to prevent recurrence of heart disease
or stroke
is now negative.
These medicines
can still be
used to reduce levels of certain types of blood fat
called triglycerides
.
Information for
patients
•
Latest data on
omega
-3 fatty acid medicines
show
that these medicines are not effective at
prevent
ing
further
problems
with the heart and blood vessels in patients who have had a heart
attack
.
•
There are alternative treatment options to prevent recurrence of heart problems
after
a heart
attack
.
•
If you are using
omega
-3 fatty acid med
icines
to reduce the risk of heart problems
your doctor will
advise on the best alternative
treatment option for you.
•
Omega
-3 fatty acid medicines
are still authorised to reduce levels of certain types of blood fat
called triglycerides
. Therefore
, if you
are using these medicines for this purpose
you should
continue your treatment.
•
There are no
new
safety
concerns
associated with the use of omega
-3 medicines.
•
If you have any questions
or concern about omega
-3 fatty acid medicines
contact your treating
doctor.
Omega
-
3 fatty acid medicines no longer considered effective in preventing heart
disease
EMA/712678/2018
Page
2
/
2
Information
for
healthcare professionals
•
Omega
-3 fatty acid medicines
will no longer be authorised for secondary prevention after
myocardial infarction
.
•
This is based on a review of all the available data on the efficacy
of omega
-3 fatty acid medic
ines
in this indication.
•
The review looked at results of the open
-label
‘GISSI
Prevenzione
’ study performed in 1999
which
supported the initial authorisation of these medicines, as well as retrospective
cohort studies, more
recent randomised
controlled
tri als
and
results
of meta
-analyses.
•
The
review concluded that
, while a small
relative risk reduction was seen in the original open label
GISSI
Prevenzione
study
, such
beneficial effects were not
confirmed
in more
recent
randomised
controlled
trials
.
•
This
review
does not affect the authorisation of omega-3 fatty acid medicines for the treatment of
hypertriglyceridaemia
.
More about the medicine
Omega 3-
fatty acid medicines
contain the fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic
acid (DHA) commonly found in fish oils. They are taken by mouth
and are authorised in several
EU
countries for preventing heart disease or stroke after a heart attack (in combination with other
medicines) and for reducing certain types of blood fats. This review is focused on the medicines' use in
patients who have had a heart attack.
More about the procedure
The review of omega
-3 fatty acid medicines was started
on 22 March 2018 at the request of the
Swedish medicines agency under
Article 31 of Directive 2001/83/EC
.
The review has been
carried out by the Committee for Medicinal Products for Human Use (CHMP),
responsible for questions concerning medicines for human use,
which
has
adopt
ed
the Agency’s
opinion. The CHMP opinion will now
be forwarded to the European Commission, which will issue a final
legally binding decision applicable in all EU Member States.
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