It is common knowledge that the oral contraceptive known as Yaz/Yasmin causes blood clots (and, in some cases, venous thromboembolism [VTE]). But although side effects often are listed with the pharmaceutical information provided with any prescription drug, the actual label itself rarely possessed this information… until now. More than likely, Bayer’s new label information is the result of negative press and pressure from the FDA.
Regardless of why the drug has a new face, Yaz is in agreement with the FDA. Bayer (the maker of Yaz) has updated its label and confirmed that there is proof that the risk in developing VTE in Yaz users is comparable to other combination oral contraceptives that contain levonorgestrel. What this mostly means is that the company is admitting to posing the same risk in Yaz as in other combination oral contraceptives.
The new label also provides information specific to drospirenone in contraceptive drugs. In fact, Kemal Malik M.D., CMO at Bayer HealthCare, has stated that “the FDA’s thoughtful and balanced analysis will provide helpful information for healthcare professionals to use when they are providing guidance and counsel to patients.”
This statement is in reference to the FDA’s having weighed the evidence of the risks of using combination oral contraceptives and insisting that drug makers not underscore the importance of protocol methodology on the outcomes and research discoveries that are conducted in scientific studies of potential risks and side effects.
According to a U.S. study, the chances of experiencing thromboembolism while taking Yaz proved to be comparable to those using other combination oral contraceptives. On Yaz/Yasmin labels, you will see that Bayer also claims that the number of Yaz thromboembolism cases is small (1.2 percent of all cases), making the risk estimates and findings from scientific studies less than reliable.
As Bayer tries to stand behind Yaz, it also is trying to take a reasonable amount of responsibility for its own label information. Regardless of whether the FDA had a strong hand in that, the consumer will have easier access to what the risks and dangerous side effects of the drug are.