The FDA has announced it is conducting a safety review of Yaz, Yasmine, Ocella and other birth control pills containing the synthetic hormone drospirenone. The announcement comes after the European Medicines Agency (EMA) announced it was updating the labeling of drospirenone-containing birth control pills to say that these birth control pills carried a higher risk of venous thrombosis and potentially fatal pulmonary embolism. The EMA action was in response to the publication of two new studies in the British Medical Journal showing that this type of birth control pill carried a threefold increased risk of venous thromboembolism.
Venous thrombosis is when a blood clot forms inside the veins. A serious form, known as deep vein thrombosis or DVT is when large clots form in the deep veins, primarily the large ones in the legs. An embolism is when one of these clots breaks loose, then becomes lodged elsewhere in the body. Pulmonary embolism is when one of these blood clots becomes lodged in the blood vessels of the lungs. Pulmonary embolism is often fatal.
We have long known these are dangerous drugs. As early as 1995, published studies showed that third-generation birth control pills containing desogestrel and related compounds (like drospirenone) were associated with a doubling of the risk of pulmonary embolism and venous thrombosis. As a result of this and more than a dozen other studies, the group Public Citizen petitioned the FDA for an outright ban on this type of birth control pill in 2007.
In its safety review announcement, the FDA notes that there is conflicting information on the actual safety profile of drospirenone-containing birth control pills. There are two studies that show these birth control pills have no higher risk than other pills, and four that show increased risk. Notably, the two studies showing no risk were post-marketing analysis studies run by the drug manufacturers.
As we have seen with Avandia, drug manufacturers know how to design studies that will conceal the risks posed by their product, and these studies definitely seem like that type. In both studies showing essentially no increased risk, drospirenone-containing birth control pills are compared to all birth control pills, including other desogestrel-type pills, which we already know carry an increased risk. However, all the studies that show an increased risk for drospirenone are ones that compare it to older types of birth control show that drospirenone carries a significantly increased risk of thromboembolism, as summarized in this table:
Lidegaard, et al (2009) doi: 10.1136/bmj.b2890
levonorgestrel (no oral contraceptive)
Van Hycklama, et al (2009) doi:10.1136/bmj.b3164
Jick and Hernandez (2011) doi:10.1136/bmj.d2519
Parkin, et al (2011) :doi:10.1136/bmj.d2519
The FDA is unlikely to take any action until it finishes review of its own large study on hormonal contraceptives. This data is expected late this summer.
In the meantime, though, women are encouraged to learn more about the birth control method they are using and talk to their doctor about the relative risk of their method versus others that are available.
If you have suffered injury or lost a loved one as a result of using these dangerous drugs, you may be eligible for compensation. The pharmaceutical liability lawyers of Robert W. Kerpsack, CO, LPA stand ready to help you. To learn more, contact us today for a free case evaluation.