FDA wants blood clotting data added to Yaz, Yasmin, others

Posted by Sarah Showard | May 03, 2012 | 0 Comments

Based on a recently completed safety review, the FDA has concluded that birth control pills containing drospirenone (a synthetic version of the female hormone progesterone, also known as progestin) may be associated with a higher risk for blood clots than other progestin-containing pills. The FDA is adding information about the studies to the labels of drospirenone-containing birth control pills such as Yaz, Yasmin, Beyaz, and Safyral (as well as their generic versions).

According to the FDA, drospirenone is also found in Gianvi, Loryna, Ocella, Syeda, Zarah, and the generic drospirenone and ethinyl estradiol.

The FDA states that the revised drug labels will note that some studies reported as high as a three-fold increase in the risk of blood clots for these products containing drospirenone when compared to products containing levonorgestrel or some other progestins, while other studies found no additional risk of blood clots with drospirenone-containing products.

Bayer is currently defending Yaz and Yasmin products in hundreds of liability lawsuits, and maintains that the pills are safe. The manufacturer says that other risk factors could account for the increased incidence of blood clots in some studies, yet agrees with the FDA's label changes.

Further reading:
FDA adds clotting data to Bayer's Yaz, Yasmin
FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Womens Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorne...


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