Panel Says Yaz Label Should Be Re-Written

In a 21 to 5 vote, the U.S. Food and Drug Administration said that the labels on certain oral contraceptive drugs should be rewritten to reflect risks accurately. The pills in question contain the hormone drospirenone. The brand names for these products include Yaz, Yasmin, Beyaz and Sayfral.

Some studies suggest that the risk is higher for venous thromboembolism (VTE) in birth control pills with drospirenone than those with another hormone called levonorgestrel, a progestin. VTE occurs when blood clots break away and move around in the circulatory system. But the results are conflicting, and the labels for these products should communicate that uncertainty, FDA panel members said.

The majority of the committee members said that the benefits—mainly preventing pregnancy—still outweigh the risks for pills containing drospirenone. Many said that while the relative risk of these drugs was shown to be higher in some studies of VTE, the absolute risk level is still relatively low. The committee concluded that further investigation into drospirenone-containing pills needs to be conducted.

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