Texas Yaz LawsuitSeptember 10, 2012 — The U.S. Food and Drug Administration (FDA) has published a safety review to evaluate the use of Beyaz birth control pills in people under 17 years old.

There are no epidemiological studies specifically investigating Beyaz in children and teens, but Beyaz contains drospirenone, a synthetic hormone that has been linked to an increased risk of blood clots. Other studies indicate that women under 30 are more likely to suffer from blood clots than older women using a drospirenone-containing contraceptive.

When the FDA reviewed the adverse event database, they found Beyaz was associated with 467 adverse events. Of those, 19 cases (4%) involved women under 17 years old. Six of these incidents involved venous thromboembolisms (VTEs), three incidents involved pulmonary embolisms, and one incident involved a retinal blood clot. Fortunately, Beyaz was not linked to any pediatric deaths.

The FDA has already updated the risk information on Beyaz to include warnings about the risk of blood clots. The reviewers also listed several epidemiological studies linking drospirenone to a higher risk of blood clots than levonorgestrel, another type of synthetic progestin. The reviewers also cited two studies that found women under 30 who take a drospirenone-containing contraceptive are more likely to suffer a venous blood clot than older women.

According to the reviewers,

“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.”

They did not find any unexpected or substantial increased risks among children taking Beyaz. However, the report did contain studies indicating that a substantial proportion of young women between 10-24 years old. Contraceptives are often used for non-contraceptive purposes, such as acne reduction, menstrual pain, and menstrual regulation. The report highlights the increased risk of blood clots faced by young women.

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