Beyaz is a newer-generation contraceptive that contains drospirenone, which has been linked in some studies to an increased risk of blood clots. Although all birth control comes with a risk of blood clots, contraceptives that contain drospirenone could have up to three times the risk of blood clots as compared to other forms of birth control, according to the US Food and Drug Administration (FDA). Drospirenone is a man-made version of the female hormone progesterone (also sometimes called progestin). In addition to drospirenone, Beyaz also contains levomefolate calcium.
According to a Beyaz Safety Review, the FDA Adverse Event Reporting System (AERS) received 467 adverse event reports for Beyaz, including 19 pediatric reports (defined as reports in patients between the ages of 0 and 17 years). Of the 19 pediatric reports, nine were serious. Overall, of the 467 reports, five patients died. None of the deaths involved patients under the age of 17, although in one death the age was not reported.
Furthermore, the safety report notes, some studies have shown an increased risk of venous thromboembolic events in women exposed to drospirenone-containing contraceptives (there have reportedly been no safety studies on Beyaz specifically, but studies have examined similar contraceptives).
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Women determining which contraceptive to use might not be put off by the mention of 467 adverse event reports associated with Beyaz, although that number is likely much lower than the actual number of adverse events experienced, because reporting to AERS is voluntary. But there is enough concern about the risks associated with drospirenone that on April 10, 2012, the FDA required contraceptive makers to include a warning about the risks on the label.