September 10, 2012 — The FDA has reviewed the adverse event database to evaluate the safety of Beyaz in pediatric patients (people under 17 years old) and published a summary of the investigation.
Although no epidemiological studies have evaluated Beyaz specifically, the FDA found Beyaz associated with hundreds of adverse event reports. They concluded that Beyaz is likely associated with the same risks as other drospirenone-containing contraceptives. Furthermore, studies indicate that women under 30 are more likely to have blood clots while taking drospirenone than older women.
The FDA reviewed deaths and adverse events associated with the use of Beyaz in patients under 17 years old. The review found 467 reports for Beyaz, of which 4% (19 reports out of 467) involved people under 17 years old. There were 6 incidents involving venous thromboembolisms (VTEs), including 3 pulmonary embolisms and one retinal thromboembolism. There were no pediatric deaths associated with Beyaz.
The FDA has recently updated the label on Beyaz and other contraceptives containing drospirenone to warn that they may be associated with a higher risk of blood clots than contraceptives containing levonorgestrel. Beyaz contains the synthetic hormone drospirenone, and many studies have linked drospirenone to a higher risk of blood clots. Two studies have found the risk of blood clots associated with drospirenone contraceptives is higher for women younger than 30-35 years old compared with older women.
The FDA reviewers wrote,
“Other than studies required by regulatory agencies, which showed no increased VTE risk, most other epidemiological studies reported a two- to three-fold increased VTE risk with drospirenone containing products compared to other progestin-containing products.”
The reviewers found no unexpected evidence of pediatric safety concerns with Beyaz. However, they did find studies indicating that a substantial proportion of women between 10-24 years old use a contraceptive (often for non-contraceptive purposes, such as acne, menstrual pain, and menstrual regulation). Furthermore, they found that studies indicate a higher risk of blood clots and venous thromboembolisms (VTEs) for women under 30 years old.