The Food and Drug Administration approved Yaz and Yasmin based on research that Bayer provided saying that the drugs were safe. We've been saying all along that the research was suspect and that, in fact, the drug is more risky than other birth control pills with no added benefits. The danger, we said, was the drugs' unique ingredient, drospirenone.
In April, two independent studies were published concluding that Yaz and Yasmin are, in fact, two to three times more likely to cause potentially lethal blood clots than competing birth control pills. The studies can be found here and here.
Now the FDA has taken notice. Yesterday, it released a "safety announcement" concerning the drugs. As part of it's "ongoing safety review of birth control pills that contain drospirenone" (Yaz and Yasmin were the first and hold the largest market share), the FDA says it will take another look at the risks the drugs carry. It will look most closely at the risk of death resulting from blood clots:
A blood clot that forms in a deep vein in the body is called a deep vein thrombosis (DVT). A DVT is a rare side effect of taking birth control pills. A blood clot can break loose from the vein, move through the body to the lung, and cause a serious problem in the lung, called a pulmonary embolism (PE). This can lead to death.
The FDA says that it will do two things to see whether Yaz and Yasmin do, in fact, have a higher risk of blood clots and death. First, it will be looking closely at the new studies. Second, it has commissioned its own "large study exploring the association of blood clots with hormonal contraception." It says that the results of that study are "currently being finalized and reviewed."
Depending on what it determines, the FDA could (1) do nothing, (2) work to take the drugs off the market, or (3) order a stronger warning so that women who use the drugs know the risks.
Meanwhile, the 6000 lawsuits brought by women injured after using the drugs march toward trial. The first cases will be tried next year.