On December 8 of this year, the FDA will have a meeting of both the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. These Committees are meeting to consider the risk of blood clots to women associated with taking birth control pills that contain drospirenone. The Bayer pills, Yaz and Yasmin, are some of the most widely used brands containing this chemical.
Just yesterday, the FDA came out with the results of a study
that showed women taking birth control pills containing drospirenone were 74 percent more likely to develop clots than women taking low-estrogen pills. Also published this week was a study in the British Medical Journal
which found that drospirenone caused a six-fold increased risk of venous thromboembolism (otherwise known as deep vein thrombosis). These clots typically form in the legs and can move to the lungs. Both of these studies should be front and center at the Advisory Committee meetings.
The judge handling the MDL involving this litigation has indicated he wants the cases to move toward settlement. These studies do not bode well for Bayer in limiting the damage amounts in any potential settlement. They do, however, tend to indicate that the women claiming that Yaz and Yasmin caused their blood clots have a very valid point and a good case.