Product Liability

FDA: Yaz, Yasmin put users at risk for dangerous blood clots

Drug regulators will take a closer look at the birth control pills containing the hormone drospirenone, such as Bayer’s popular pills Yaz and Yasmin, during a meeting with advisers next month. At issue is the safety of the pills, which the Food and Drug Administration (FDA) said in an announcement released this week puts women at a 74 percent greater risk of suffering from dangerous blood clots than other low-estrogen pills.

The FDA cited recent studies that evaluated data from 835,826 women ranging in age from 10 to 55 who were taking pills containing drospirenone over time. The agency’s findings confirm previous studies that suggest newer generation pills, including those containing dropsirenone, carry twice the risk of blood clots compared to older birth control pill formulations.

Yaz and Yasmin were heavily promoted in the United States and other countries in the early 2000s, earning billions for Bayer. Recent reports of health concerns and generic competition has resulted in a 13 percent drop in sales of the pharmaceutical giant’s popular oral contraceptives. Bayer also faces lawsuits from women or their families who claim they suffered blood clots, strokes, heart attacks, gallbladder damage and even death after using the pills.

Bayer has continuously defended Yaz and Yasmin, claiming that the oral contraceptives are no more dangerous than other birth control pills. Following the FDA’s announcement, the drug company said it will hold further remarks until it meets before the agency’s panel in December.

Business Week
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