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

Swiss regulatory authority Swissmedic announces results of its analysis of current studies on the risks of hormonal contraceptives: The risk of venous thromboembolism for drospirenone containing oral contraceptives is comparable to the risk of other oral contraceptives available on the market

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 http://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 http://www.bayerscheringpharma.de.

Forward-looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at http://www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

 

Posted: October 2009

View comments

Hide
(web3)