The UK medicines regulator has written to GPs with a checklist to use when prescribing combined hormonal contraceptives, to help them assess the risk of thrombotic complications.
The advice from the Medicines and Healthcare Products Regulatory Agency (MHRA) comes after a review by the European Medicines Agency (EMA) confirmed combined hormonal contraceptives are associated with a small but significantly increased risk of venous thromboembolism (VTE).
The EMA review, findings of which were announced last November, concluded the benefits of the contraceptives outweighed the risks, but advised doctors to consider how the risk of VTE with a particular product, compared with others.
The risk varied from between five and twelve cases of VTE per 10,000 women each year, depending on the type of progestogen used, compared with two VTE cases per 10,000 women annually not using a combined hormonal pill, patch or ring.
The progestogens levonorgestrel, norethisterone and norgestimate had the lowest risk.
In the circular sent to prescribers, the MHRA reminded GPs of the ‘importance of an individual woman’s risk factors and the need to regularly assess them, and raising awareness of the signs and symptoms of VTE and ATE which should be described to women when a CHC is prescribed’.
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Dr Sarah Branch, deputy director of the MHRA Vigilance and Risk Management of Medicines Division, said: ‘No important new evidence has emerged – this review simply confirms what we already know, that the risk of blood clots with all combined hormonal contraceptives is small.
‘If women have questions, they should discuss them with their GP or contraceptive provider at their next routine appointment but should keep taking their contraceptive until they have done so.’
Merck-Sharpe and Dohme (MSD), which manufactures the desogestrel-containing combined pills Marvelon and Mercilon, said ‘the company is confident in the efficacy and safety profiles’ of its products, as described in the summary of product characteristics.
A spokesperson for the company said: ‘A woman should work with her healthcare professional to understand and find a contraceptive option that is right for her as an individual.’
Bayer, which manufactures combinations including gestodene (Femodene, Triadene), drospinerone (Yasmin) and dienogest (Qlaira), said: ‘Bayer will update product information, including the packaging leaflet, to provide additional information to women and prescribers on the known risk of thromboembolism and its risk factors, signs and symptoms. This will further support women together with their healthcare providers to make informed decisions about their method of contraception.’
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