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FDA Landmark Study on the risks of Birth control such as Yaz, Yasmin, Ocella, Nuvaring and Ortho Evra

Breaking news was released from the FDA this morning concerning a landmark study of the risk of arterial and venous cardiovascular complications caused by Yaz, Yasmin and Ocella.

Until now, there was limited data available regarding the risk of venus thromboembolism (VTE) (deep venous thrombosis [DVT] and pulmonary embolism [PE]) in combined hormonal contraceptives (CHCs), such as Yaz, Yasmin and Ocella, which contain estrogen and drospirenone. The FDA conducted a study which reviewed data from four health plans, which included 835,826 women to evaluate the risk of thrombotic and thromboembolic events and all-cause and cardiovascular mortality. 

The FDA utilized computerized data from Kaiser Permanente Northern California, Kaiser Permanente Southern California, Tennessee State Medicaid and Washington State Medicaid.

After the statistical analyses were performed, it was determined that birth control such as Yaz, Yasmin and Ocella which contained drospirenone were associated with a significantly higher risk of VTE relative to other low-estrogen comparators, with a relative risk of 1.74 percent, which means almost two times greater risk

The FDA also considered the risks associated with use of the CHC relative to comparator in new users (CHC use started during the study period) and found that drospirenone was associated with an higher risk of VTE as follows (<3 mos=1.93 percent; 6-12 mos = 2.80 %) You should note that the Ortho Evra patch and Nuva Ring vaginal ring were also studied, and presented significantly higher risks of VTE. The study also found that the risks were higher in the younger age groups (10-34) than the older age groups (35-55). 

The study concludes that the transdermal patch is associated with a higher risk of VTE than standard pills, but also provides strong evidence of an increased risk of VTE with Yaz, Yasmin and Ocella relative to standard low dose CHC pills. The finding also raises concern about the vaginal ring. 

The study, including the Executive Summary, can be found at the following link http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf.

Feel free to contact Scott Levensten, Esquire, at sdl@levenstenlawfirm.com, or 215-545-5600 with any questions concerning the study, and/or filing a lawsuit for injuries caused by any of the forms of birth control studied by the FDA.

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