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Societe-francophone-contraception.com

11 October 2013
EMA/607314/2013
Press Office

Press Release
PRAC confirms that benefits of all combined
hormonal contraceptives (CHCs) continue
to outweigh risks

Committee recommends that women and prescribers be
better informed of the known risk of thromboembolism
and alert for signs and symptoms

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed
the risk of venous thromboembolism (VTE or blood clots in veins) with combined

hormonal contraceptives (CHCs). The PRAC concluded that the benefits of CHCs
in preventing unwanted pregnancies continue to outweigh their risks.

There is no reason for women who have been using CHCs without any problem
to stop taking them on the basis of this review. It is important that women are
made aware of the risk of VTE and its signs and symptoms, and that doctors

take into consideration a woman’s individual risk factors when prescribing a
contraceptive.

This review has confirmed that the risk of VTE with all CHCs is small and has
shown that there are small differences between the CHCs depending on the type
of progestogen they contain. It has reinforced the importance of ensuring good

information for women who use these medicines and for the healthcare
professionals providing advice and clinical care.

When prescribing a CHC, doctors should assess a woman’s individual risk for
blood clots regularly, as the risk changes over time. Risk factors include among
others smoking, being overweight, increasing age, having migraines, family
history of VTE and having given birth in the previous few weeks. Doctors should

also consider how the risk of VTE compares with other CHCs.
It is important that women and doctors remain alert for the signs and symptoms
of thromboembolism, which may include severe pain or swelling in the legs,

sudden unexplained breathlessness, rapid breathing or cough, chest pain, and
face, arm or leg weakness or numbness. In case a woman develops any of these

signs and symptoms she should seek medical advice immediately.
The PRAC recommendation will now be forwarded to the Committee for
Medicinal Products for Human Use (CHMP) which is expected to adopt an EMA
final opinion at its plenary meeting of 18-21 November 2013.¹
The risk of VTE with CHCs differs among products depending on the type of
progestogen they contain. Having assessed all the available data, the PRAC
concluded that:

The risk is lowest with the CHCs containing the progestogens
levonorgestrel, norgestimate and norethisterone: it is estimated that each
year there will be between 5 and 7 cases of VTE per 10,000 women who

use these medicines.
The risk is estimated to be higher with the progestogens etonogestrel and
norelgestromin, with between 6 and 12 cases yearly per 10,000 women.
The risk is also estimated to be higher with the progestogens gestodene,
desogestrel, drospirenone, with between 9 and 12 cases yearly per 10,000
For CHCs containing chlormadinone, dienogest and nomegestrol, the
available data are insufficient to know how the risk compares with the
other CHCs, but further studies are ongoing or planned.

For comparison, in women who are not using CHCs and who are not pregnant,
there will be around 2 cases of VTE each year per 10,000 women.
The review also looked at the risk of arterial thromboembolism (ATE, blood clots
in arteries, which can potentially cause a stroke or heart attack). This risk is
very low and there is no evidence for a difference in the level of risk between
products depending on the type of progestogen.

The product information, including the package leaflet, will be updated to help
women make informed decisions about their choice of contraception together

with their healthcare professional. In the meantime, women who have any
questions or concerns should discuss them with their doctor at their next

routine appointment.
More about the medicine
CHCs contain two types of hormones, an oestrogen and a progestogen. The
review included all contraceptives containing low-dose oestrogen and the

following progestogens: chlormadinone, desogestrel, dienogest, drospirenone,
etonogestrel, gestodene, nomegestrol, norelgestromin and norgestimate. These
are sometimes referred to as ‘third generation’ or ‘fourth generation’

contraceptives and are available as pills, skin patches and vaginal rings. During
the review, the risk of VTE with these medicines was compared with that of

CHCs containing levonorgestrel and norethisterone (also known as ‘second
generation’ contraceptives).

With the exception of Zoely (nomegestrol acetate/estradiol), Ioa (nomegestrol
acetate/estradiol) and Evra (norelgestromin/ethinylestradiol), which have been
authorised centrally through the EMA, all other combined contraceptives in the

EU have been authorised via national procedures.
More about the procedure
The review of combined hormonal contraceptives was initiated in February 2013
at the request of France, under Article 31 of Directive 2001/83/EC.
The initial step of this review has been carried out by the Pharmacovigilance
Risk Assessment Committee (PRAC), the Committee responsible for the

evaluation of safety issues for human medicines, which has made a set of
recommendations. The PRAC recommendations will now be forwarded to the

Committee for Medicinal Products for Human Use (CHMP) which will adopt an
EMA final opinion. The final stage of the review procedure is the adoption by the

European Commission of a legally binding decision applicable in all EU Member
¹ The companies that market CHCs have the right to ask for a re-examination of
the PRAC recommendation within 15 days of receipt of the PRAC
recommendation, which would delay the expected time of finalisation of this

Source: http://societe-francophone-contraception.com/userfiles/EMA_PRAC_Report_11_October_2013.pdf

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