Bayer updates drospirenone-containing COCs labels to reflect VTE risk

Following a further review of the products by the US Food and Drug Administration , Bayer HealthCare Pharmaceuticals, a US unit of Germany-based Bayer (BAY: DE), has agreed to update the labels for its drospirenone-containing combination oral contraceptives (COCs) in the USA.

The new FDA labeling applies to Bayer’s Yasmin, Yaz (drospirenone/ethinylestradiol) and Beyaz (drospirenone and ethinyl estradiol and levomefolate calcium tablets, and levomefolate calcium) products, as well as generics and other brands of COCs that contain drospirenone. Yaz alone generated global sales of 1.07 billion euros ($1.4 billion), despite already facing generic competition in the USA.

The updated labels include additional information from recently published studies evaluating the risk of venous thromboembolism (blood clots) in women taking drsp-containing COCs. Specifically, the new labels state that COCs containing drospirenone may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins.