FDA Yaz Investigation

At the end of May 2011, the U.S. Food and Drug Administration (FDA) announced it was conducting a review of the safety of certain birth control pills, such as Yaz and Yasmin from Bayer, due to concerns that the drugs may increase the risk of blood clots, significantly more than other birth control pills.       

While all hormonal birth control pills increase the risk of blood clots, the review by the FDA focuses on pills that contain the hormone drospirenone. Two recent studies published in the British Medical Journal (BMJ) discovered that women ages 15 to 44 that were taking birth control pills that contained drospirenone were two to three times more likely to develop venous thromboembolism, which are blood clots that grow in the deep veins of a person’s legs, when compared to women taking older pills that contained the progestin levonorgestrel.

Regulators in Europe have stated they will be revising prescribing information for appropriate products that will include information regarding the findings of the recent studies. The FDA will investigate whether the agency should do the same, but is remaining cautious since data from previous studies contradicts the new research. According to the agency, other studies have not found an increase in blood clot risks in women taking drospirenone-containing birth control pills. Drospirenone-containing products include Yaz (its generics Loryna and Gianvi), Yasmin (its generics Zarah, Syeda, and Ocella), Safyral, and Beyaz.

While the FDA conducts its investigation, the agency does not recommend women who are taking birth control pills that contain drospirenone stop taking their medication before consulting with a healthcare professional first. However, if any signs of blood clots arise, including severe chest pain, persistent leg pain, or sudden shortness of breath; a healthcare professional should be contacted immediately.

This is not the first time concerns have been raised regarding Yaz. In 2009, the FDA asked its manufacturer, Bayer, to correct the advertising campaign for the drug after regulators said ads for Yaz overstated its abilities, including controlling premenstrual symptoms and preventing acne. Bayer had to spend $20 million on a new campaign that clearly stated the true benefits as well as the risks of Yaz.

Numerous lawsuits have also been filed against Bayer by consumers that allege they have developed serious health problems after taking Yaz. Severe side effects have been linked to the drug, including brain damage, heart attacks, kidney damage, and gallbladder disease. High blood pressure and elevated cholesterol have also been linked to Yaz. Many of the plaintiffs in these lawsuits are women who are non-smokers and were otherwise healthy before taking the drug. Wrongful death lawsuits have also been brought against the drug manufacturer for women who have died as a result of taking Yaz.

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