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Beyaz Pulmonary Embolisms Reported to FDA

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Washington, DC: The Food and Drug Administration (FDA) has received reports of pulmonary embolism, shortness of breath, chest pain, abdominal pain, back pain, rash and weight gain associated with the oral contraceptive Beyaz.

Beyaz, made by Bayer HealthCare Pharmaceuticals, contains Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg. Drospirenone, a type of female sex hormone also called a progestin, is linked to an increased risk for blood clots. In 2011, the FDA issued a safety communication concerning drospirenone-containing birth control pills, which states, "Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives."

In 2012, after reviewing the available evidence concerning the risk for blood clots with drospirenone, the FDA issued a further statement, which said "… FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills."

Symptoms of blood clots include persistent leg pain, severe chest pain, or sudden shortness of breath. These are the symptoms being reported in the FDA' Adverse Events Reporting Database by physicians whose patients are using Beyaz.

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