FDA Concerned about Birth Control Safety, But Hasn’t Reached Conclusion Yet

Yesterday, the Food & Drug Administration (FDA) announced that it would continue to review studies regarding the risks of blood clots in women taking birth control pills that contain the hormone Drospirenone, such as Yaz and Yasmin.

The studies under review include two studies conducted this year and a separate study funded by the FDA to evaluate the risks of blood clots in women using several different types of hormonal birth control products. The preliminary results of these studies show that women taking birth control containing Drospirenone have a 1.5 increased risk of developing a blood clot, as compared to women taking other types of hormonal birth control.

Blood clots, or venous thromboembolic events (VTE), are more likely to occur in women who use hormonal birth control products that contain Drospirenone. Also, women who are over the age of 35, who smoke, who are overweight, and who have a family history of blood clots have a higher risk of experiencing VTE. The risk of VTE is highest during the first year of using Drospirenone and when resuming use of these pills after a break of four weeks or longer.

Nearly 10 in 10,000 women will develop a blood clot while using Drospirenone. For women using other forms of hormonal birth control, the risk of developing a blood clot is six in 10,000.

The FDA will continue to evaluate the risk Drospirenone poses. On December 8, 2011, the Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet to discuss the risks and benefits of this medicine. At this time, the FDA is expected to make a final conclusion regarding these drugs.

For now, the FDA recommends that women continue to take these birth control pills, unless their doctor recommends they change to another birth control. More specifically, the FDA recommends that women 35 and older who smoke not take birth control containing Drospirenone. Women who have a history of blood clots, heart attack, or stroke, and women who are pregnant or who think they may be pregnant should not take these pills.

If you experienced a VTE or blood clot while taking Yaz, Yasmin, or another birth control containing Drospirenone, you deserve to know your legal rights. The knowledgeable dangerous drug attorneys at Van Wey Law may be able to help you. Call us today at (800)489-5082 or (214)329-1350.