2013-02-11 Not intended for U.S. and UK Media
EU Referral Procedure concerning the so-called third and fourth generation combined hormonal contraceptives
Berlin, February 11, 2013 – Bayer HealthCare Pharmaceuticals is aware of the initiation of a Referral Procedure pursuant to Art. 31 of Directive 2001/83/EC concerning numerous combined hormonal contraceptives authorized in the European Union (EU) which has been published on February 8th, 2013, on the website of the European Medicines Agency (EMA). The Referral has been requested by the French Health Authority (ANSM) following concerns about the risk of venous thromboembolism (VTE) in France. The EMA will now review all available data on the risk of VTE with these contraceptives and issue an opinion on whether any changes are needed to their prescribing advice across the EU.
This Referral concerns various combined hormonal contraceptives marketed by different manufacturers. The classification of these combined hormonal contraceptives into so-called generations relates to the time of their market introduction. Bayer combined hormonal contraceptives included in this Referral are combined oral contraceptives (COCs), i.e. combinations of ethinylestradiol and gestodene, drospirenone or dienogest as well as combinations of estradiol valerate and dienogest.
Bayer believes that all relevant information is included in the product information of its COCs and that these texts reflect the currently available scientific evidence.
Modern low-dose COCs are an important method of family planning.
COCs are among the most systematically studied and widely used medicinal products avail-able today. Bayer’s COCs have been and continue to be extensively studied worldwide.
The use of any COC, including COCs from Bayer, carries an increased risk of venous and arterial blood clots. These serious side effects are known but rare events and extensively described in the product information. Venous blood clots (venous thrombosis) or their potential to break free and travel into lung vessels, eventually blocking them (pulmonary embolism) are among the most serious side effects of taking COCs. Venous thromboembolism (VTE) is a known rare event among women using COCs, and the risk for VTE in women who take low-dose COCs is lower than the risk for VTE associated with pregnancy and following childbirth. COCs increase the tendency to develop arterial blood clots which can lead to strokes (due to the blockage or rupture of blood vessels in the brain) and heart attacks (due to the blockage of blood vessels in the heart).
Based on a thorough assessment of the available scientific data by regulatory authorities, external independent experts and Bayer scientists, Bayer’s low-dose COCs have a favorable benefit risk profile when used as directed. Furthermore we are not aware of any new scientific evidence available that would lead to a changed benefit-risk equation of the COCs currently under discussion.
Bayer fully stands behind all of its combined oral contraceptives and we have been and will be working closely together with the Health Authorities.
Bayer is committed to discuss and to answer all questions that the Health Authorities might have.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture 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. More information at www.healthcare.bayer.com.