European Union Safety Review Prompts Changes to Yasmin/Yaz Labeling

European Union Safety Review Prompts Changes to Yasmin/Yaz Labeling

By Burg Simpson
April 16, 2010
2 min read

Burg Simpson News Updates

Bayer is to strengthen the label for its Yasmin birth control pills sold in the European Union, according to a recent announcement by the EMEA. The EMEA reviewed four published studies concerning the risk of blood clots, or venous thrombotic events [VTE], for users of Yasmin in comparison to women using other birth control pills. The EMEA stated: “Recently, two epidemiological studies were published, both assessing the risk of VTE in current users of different types of COCs. The results of these studies . . . suggested that the risk for the COCs Yasmin … might be higher than previously estimated, and between those of second and third generation pills.”

The rate of VTE for women taking second generation pills, which are those containing levonorgestrel as the progestin component, is consistently estimated to be approximately 20 per 100,000 women years, while the rate for the third generation pills is 40 per 100,000 women years. Third generation products typically carry a warning in the United States that the risk of VTE may be double that of second generation pills.

How soon Bayer will begin updating its Yasmin label and product information in Europe is unknown. It is also unclear if Bayer intends to make any alterations to the Yasmin warning labels in the United States.

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