FDA Begins Safety Review of Popular Birth Control Pills Over Blood Clot Risk

The Food and Drug Administration (FDA) announced yesterday that the agency is launching an investigation into newer “fourth generation” birth control pills including Yasmin and YAZ due to new medical studies suggesting that women have a 2 to 3 times increased risk of developing blood clots. Yasmin and YAZ birth control pills differ from all other oral contraceptives because they contain a specific type of hormone called drospirenone. In addition to Yaz and Yasmin, drospirenone is found in birth control pills sold under the brand names Beyaz and Safyral. The hormone drospirenone is also an ingredient in generic forms of Yaz (Gianvi, Loryna) and Yasmin (Ocella, Syeda, and Zarah).

The FDA references two medical studies reporting a greater risk of venous thromboembolism (VTE) associated with birth control pills containing drospirenone. The two studies referenced by the FDA were published in April 2011 in the British Medical Journal.  The studies found that women aged 15-44 taking drospirenone birth control pills were two to three times more likely to develop venous thromboembolism (VTE) over older oral contraceptives containing the progestin levonorgestrel.  The FDA indicated that other studies have not reported an increase in risk. The FDA is currently evaluating the conflicting study results and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. 

Click here to read FDA Notice dated 5/31/11

Click here to learn more about the litigation involving Yasmin and Yaz