Guidance material to doctors and users of contraceptive pills

06 May 2014

The EU Pharmacovigilance Risk Assessment Committee (PRAC) recently completed a review of the risk of blood clots (VTE) with contraceptive pills and other combined hormonal contraceptives. Combined hormonal contraceptives contain two types of hormone, oestrogen and progesterone, and are available as pills, transdermal patches and vaginal rings.

Women, who use combined hormonal contraceptive pills without problems, can continue using them

The review does not give rise to discourage the use of contraceptive pills or other combined hormonal contraceptives among women who use them without any problems.

Important information about the risk of blood clots

However, it is important to inform users of contraceptive pills about the risk of venous blood clots and the symptoms they should be alert to. Moreover, it is important that doctors consider the risk factors of each individual woman before prescribing contraceptive pills.

Consequently, the Danish Health and Medicines Authority and the other European drug regulatory authorities have prepared guidance material to doctors and patients.

Guidance material to doctors and users

The guidance material contains:

  • A checklist to doctors to support consultations before prescribing the products: Word or PDF, both in Danish
  • A patient card with information about the products and symptoms of blood clots: Word or PDF, both in Danish

Information to MAHs about distribution of the material in paper form

To ensure easy access to the material, companies holding the marketing authorisations (MAHs) for the relevant products must make sure that paper copies of the material become available to the relevant doctors.

MAHs of new combined hormonal contraceptives falling within the scope of the referral under article 31 of Directive 2001/83/EC1, are expected to download, print and distribute the above-mentioned material in Danish.

We strongly recommend that the involved companies cooperate on the task so that doctors, to the extent possible, receive one letter with a sufficient number of copies of the material as well as information that more material can be downloaded on this website.

The material should be distributed to general practitioners, Danish Society of Obstetrics and Gynaecology, Danish Family Planning Association, Danish Patients and pharmacies.

More information about the review

The Danish Health and Medicines Authority has previously informed about the PRAC review: PRAC confirms the benefits of all combined hormonal contraceptives (in Danish)

In January 2014, the Danish Health and Medicines Authority communicated the conclusions of the review to the medical organisations. Read the: Direct Healthcare Professional Communication (DHPC) sent to healthcare professionals (in Danish)

1) The review comprised all types of contraception with low-dose oestrogen and the following types of progesterone: chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin and norgestimate.

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