Bayer HealthCare (BAY)'s Yaz, Yasmin to Get New Labels as FDA Warns of Blood Clot Risk
4/11/2012 7:23:54 AM
WAYNE, N.J., April 10, 2012 /PRNewswire/ -- In agreement with the U.S. Food and Drug Administration (FDA), Bayer HealthCare Pharmaceuticals Inc. today announced that it has updated the labels for its drospirenone-containing combination oral contraceptives (COCs) in the United States.
The updated labels include additional information from recently published studies evaluating the risk of venous thromboembolism (blood clots) in women taking drsp-containing COCs. Specifically, the new 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 labels state that before initiating use of a drospirenone-containing COC in a new COC user or a woman who is switching from a contraceptive that does not contain drsp, consider the risks and benefits of a drsp-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 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 drsp-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.
Healthcare providers and consumers are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
BAYER®, Bayer Cross® and drsp® are all registered trademarks of Bayer.
This news 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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SOURCE Bayer HealthCare Pharmaceuticals Inc.