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PRAC confirms that benefits of all combined hormonal contraceptives outweigh risks

11.10.2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the risk of venous thromboembolism (VTE, blood clots in veins) with combined hormonal contraceptives (CHCs). The PRAC concluded that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh the risks.

According to this review, there is no need for women who have been using CHCs without any adverse reaction to stop taking them . 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. The PRAC has reinforced the importance of ensuring good information for women who use these medicines and for prescribers.

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 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.

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 (Adexa, Leona i Tiquillar), norgestimate (Cilex) and noresthisterone (Trinovom): 5-7 cases out of 10 000 women in one year.
  • The risk is estimated to be higher with the progestogens etonogestrel (Nuvaring) and norelgestromin (Evra): 6-12 cases out of 10 000 women in one year.
  • The risk is also estimated to be higher with the progestogens gestodene (Lindynette, Logest, Naella and Yvon), desogestrel (Novynette), drospirenone (Yasmin, Yaz, Linatera, Palandra, Rosanelle, Rosanne, Softine, Softinelle): 9 cases out of 10 000 women in one year
  • For CHCs containing chlormadinone (Belara, Estal), dienogest (Qlaira, Donella) and nomegestrol (Zoely and Ioa) the available data are insufficient to know how the risk compares with the other CHCs, but further studies are ongoing or planned.

*In parentheses are indicated medicinal products having the marketing authorisations in Croatia with indications for prevention of unwanted pregnancy. With the exception of Zoely (nomegestrol acetate/estradiol), Ioa (nomegestrol acetate/estradiol) and Evra (norelgestromin/ethinylestradiol), authorised via centralised procedure, all other CHCs are authorised via national procedures in the EU.

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 PRAC’s 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 doctor at their next routine appointment.

An analysis oc CHCs consumption in Croatia has demonstrated that patients use mostly CHCs with a higher risk of VTEs, which may be seen from the diagram accessible here (in Croatian). According to the new review of CHCs risk, it is recommended to doctors to prescribe to new users CHCs having lower risk of VTEs. It is not necessary to change the prescribed CHC in patients having no problems.

The EMA’s press release is accessible here.

The previously published information about the initiation of the review of combined hormonal contraceptives is accessible under the following link:

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