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Regulatory Focus™ > News Articles > EMA Confirms Safety of Combined Contraceptives

EMA Confirms Safety of Combined Contraceptives

Posted 11 January 2013 | By Alexander Gaffney, RAC

EU regulators have declared that they have found no new evidence that combined contraceptives present a greater safety risk to women than is currently known, a response they said was called for after "growing media reports" raised questions about the safety of the products.

Combined contraceptive medications, such as Bayer's Yasmin (drospirenone and ethylestradiol), have been associated with "very rare" thromboembolisms, and are closely monitored by both EU and US regulators.

In April 2012, the US Food and Drug Administration (FDA) issued a warning regarding all drospirenone-containing products, saying the hormone might be associated with a higher risk of thromboembolisms. It was not able to control the risk of drospirenone relative to the risk of other birth control products, it said, and was continuing to study the issue.

In a statement released on 11 January 2013, the European Medicines Agency (EMA) said it was aware of "no new evidence that would suggest any change to the known safety profile of any combined contraceptives marketed today."

"Therefore," it added, "there is no reason for any woman to stop using her contraception." EMA explained that none of its member states had brought any issues related to the drugs, sometimes referred to as third-generation contraceptives, either.


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Tags: Drospirenone, EU