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Swiss regulatory authority Swissmedic announces results of its analysis


23 October, 2009  

The risk of venous thromboembolism for drospirenone containing oral contraceptives is comparable to the risk of other oral contraceptives available on the market

The Swiss regulatory authority Swissmedic has conducted an analysis with its expert medical committee on the latest data and studies regarding the risk of venous thromboembolism (VTE) associated with oral hormonal contraceptives.

The results of this analysis were announced earlier today by Swissmedic.

In its press release, Swissmedic emphasizes that oral hormonal contraceptives containing the active substance drospirenone have a comparable safety profile to that of other preparations available on the market.

Furthermore, Swissmedic confirms that the risk of VTE among all oral contraceptives is greatest during the first year of intake.

“Modern low-dose oral contraceptives, including those containing drospirenone, are an important method of family planning. Based on our wealth of post marketing safety data we are convinced about the positive benefit/risk profile of drospirenone containing oral contraceptives”, said Kemal Malik, MD, Chief Medical Officer at Bayer Schering Pharma. “These post marketing data include more than 42 million women years of drospirenone use as well as two epidemiological studies including more than 120,000 oral contraceptive users.”

Bayer Schering Pharma will continue its dialogue with the Swiss regulatory authority.