The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has confirmed that the benefits of all combined hormonal contraceptives (CHCs) continue to outweigh their risks. This follows a review by the EMA into the risk of thromboembolism (blood clots in arteries or veins) with some combined hormonal contraceptives. This recommendation by PRAC still needs to be discussed before a final decision by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in mid-November.

 

Dr Sarah Branch, Deputy Director of the MHRA’s Vigilance and Risk Management of Medicines Division, said: “Women should continue to take their contraceptive pill. These are very safe, highly effective medicines for preventing unwanted 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 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.”

 

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.

 

Posted on the UK MHRA website on 11 October 2013