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Tuesday, 15 June 2021

EU drugs agency says oral contraceptive benefits outweigh risks

Risk of clots as result of using contraceptive pills still present but benefits still greater

Reuters, Sunday 24 Nov 2013

The benefits of combined hormonal contraceptive pills such as Bayer's Meliane or Yasmin in preventing unwanted pregnancies continue to outweigh any risk of blood clots, Europe's drugs regulator said on Friday.

Announcing conclusions of a review into the safety of CHCs, the European Medicines Agency (EMA) said they carry a well-known but small risk of venous thromboembolism, or blood clots in the veins, and a "very low" risk of blood clots in arteries.

But EMA's Committee for Medicinal Products for Human Use (CHMP) concluded "that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks", the agency said in a statement.

The safety review was launched earlier this year after a request by France, where authorities want to reduce use of the contraceptive drugs.

The French government said in January it would stop reimbursing prescription costs of the newer generation CHC pills would restrict their use after a woman sued Bayer over alleged side effects.

While all oral contraceptives are associated with some danger of blood clots, a number of scientists studies have suggested that the most recent third- and fourth-generation pills carry a higher risk than their predecessors.

The London-based EMA said its review had "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".

On the risk of arterial thromboembolism - blood clots in arteries which can potentially cause a stroke or heart attack - the risk "is very low and there is no evidence for a difference in the level of risk between products," it said.

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