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Swiss regulatory authority Swissmedic announces results of its analysis of current studies on the risks of hormonal contraceptives:
Berlin, October 22, 2009 - 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.
About Bayer Healthcare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Bayer Schering
Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, General Medicine, Specialty Medicine and Women's
Healthcare. With innovative products, Bayer Schering Pharma aims for leading
positions in specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives to improve
the quality of life. Find more information at www.bayerscheringpharma.de.
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