Other safety alerts
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| Updates on combined hormonal contraceptives |
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1. European Union: Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks – CHMP endorses PRAC recommendation: Product information to be updated to help women make informed decisions about their choice of contraception
The European Medicines Agency has now completed its review of combined hormonal contraceptives (CHCs), particularly of the risk of venous thromboembolism (VTE or blood clots in veins) associated with their use. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks, and that the well-known risk of VTE with all CHCs is small.
The review has reinforced the importance of ensuring that clear and up-to-date information is provided to women who use these medicines and to the healthcare professionals giving advice and clinical care.
The product information of CHCs will be updated to help women make informed decisions about their choice of contraception together with their healthcare professional. 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. Doctors should also consider how the risk of VTE with a particular CHC compares with other CHCs.
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 CHMP opinion, in agreement with the previous recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), will now be sent to the European Commission for the adoption of a legally binding decision to update the product information of all CHCs throughout the EU.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_001969.jsp&mid=WC0b01ac058004d5c1
2. The United Kingdom: Press release: MHRA responds to European Medicines Agency review conclusions about combined hormonal contraceptives.
The related news on combined hormonal contraceptives (CHCs) was also reported at Medicines and Healthcare Products Regulatory Agency (MHRA) website. MHRA advised that patients should continue to take their contraceptive pill. These are very safe, highly effective medicines for preventing unintended pregnancy and the benefits associated with their use far outweigh the risk of blood clots in veins or arteries. 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 patients 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.”
Updated guidance and information that promotes better prescribing and greater awareness about the risk of blood clots and the symptoms will be made available to healthcare professionals and women following the conclusion of the review by the European Medicines Agency.
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON341221
In Hong Kong, combined oral contraceptives are registered pharmaceutical products. The issue related to the risk of venous thromboembolism with combined contraceptives had been released by the EU EMA and UK MHRA; and were posted on the Drug Office website on 12 January 2013, 29 January 2013 and 12 October 2013. The Department of Health will keep vigilance on any further safety updates on the above issue from other overseas health authorities.
Ends/ Saturday, November 23, 2013
Issued at HKT 14:00
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