On Friday, March 26, 2010, Bayer announced that it will update the Yasmin label in the European Union (EU). The new Yasmin label will include the results of four epidemiological studies (epidemiological studies are conducted to figure out what factors affect the health and illness of a population).
Two of those studies found that oral contraceptive pills which contain the hormone drospirenone (such as Yaz, Yasmin and Ocella) are associated with a significantly increased risk of venous thromboembolism, a medical term used to describe a blood clot in a vein, which can lead to more serious injuries including pulmonary embolism or stroke. The studies, conducted in Denmark and the Netherlands, were published last year in the British Medical Journal.
After viewing these reports, the Pharmacovigilance Working Party (PhVWP) of the Committee for Medicinal Products for Human Use (CHMP) (a section of the European Medicines Agency) concluded that users should be informed of this new risk information and became the driving force behind the addition of these two independent studies to the new Yasmin label.
The other two studies to be included on the new label (EURAS and Ingenix studies) were sponsored by Bayer, the maker of Yasmin and Yaz. Unsurprisingly, the Bayer-sponsored studies concluded that the risk of blood clots in Yasmin users is comparable to the risk found for women who use historically safer oral contraceptives which contain the hormone levonorgestrel.
At this point, the Yasmin label change is only due to go into effect in Europe and the exact language for the new label has not yet been revealed.
