April 11, 2012
Not intended for U.S. and UK media

Bayer Updates U.S. Labels for Drospirenone-containing Combined Oral Contraceptives

Berlin, April 11, 2012 - The U.S. Food and Drug Administration (FDA) and Bayer
HealthCare Pharmaceuticals have agreed to update the labels for its
drospirenone-containing combined oral contraceptives (COCs) in the United
States.

The updated labels in the U.S. include additional information from recently
published studies evaluating the risk of venous thromboembolism (blood clots)
in women taking drospirenone-containing COCs. Specifically, the new U.S. labels
state that COCs containing drospirenone may be associated with a higher risk of
venous thromboembolism (VTE) than COCs containing levonorgestrel or some other
progestins. Epidemiologic studies that compared the risk of VTE reported that
the risk ranged from no increase to a three-fold increase. The U.S. labels
state that before initiating use of drospirenone-containing COCs in a new COC
user or a woman who is switching from a contraceptive that does not contain
drospirenone, consider the risks and benefits of a drospirenone containing COC
in light of her risk of a VTE.

Women should talk to their healthcare professional about their risk for blood
clots before deciding which birth control method to use. Known risk factors for
VTE include smoking, obesity, and family history of VTE, in addition to other
factors that contraindicate use of COCs. The risk of VTE is highest during the
first year of COC use. The greatest risk of VTE is present after initially
starting a COC or restarting (following a 4 week or greater pill-free interval)
the same or a different COC.

The revised U.S. labels update information that there is a risk of VTE among
all COCs, but that the risk of VTE associated with pregnancy is even greater
than the risk associated with any COC use, including drospirenone-containing
COCs.

Bayer has consistently updated the FDA and other regulatory authorities around
the world as new data have become available regarding drospirenone-containing
COCs, and has worked with the agencies to make label updates as appropriate.

In 2011 Bayer HealthCare Pharmaceuticals updated labels for drospirenone
containing products in various countries, e.g. Europe, Canada and Australia.

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 subgroup of
Bayer AG with annual sales of EUR 17.2 billion (2011), 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, Consumer Care, Medical Care and Pharmaceuticals
divisions. Bayer HealthCare's aim is to discover, develop, manufacture and
market products that will improve human and animal health worldwide. Bayer
HealthCare has a global workforce of 55,700 employees (Dec 31, 2011) and is
represented in more than 100 countries. Find more information at
www.bayerhealthcare.com.


Find more information at www.bayerpharma.com.

Forward-looking statements<br/>
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 www.bayer.com. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to future events or
developments.

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