Revised Drug Labels for Yaz and Yasmin

The FDA recently issued a Drug Safety Communication informing the public it has completed a review study of the risk of blood clots in women taking birth control containing dropsirenone.  Drospirenone is a synthetic form of the female hormone progesterone, and is also called progestin.  The study concludes that birth control pills containing drospirenone may put users at a higher risk of blood clots.  The FDA is adding the study results to the labels of birth control pills containing drospirenone.  Yaz, Yasmin and Ocella are well known birth control pill containing this synthetic hormone.

The study did not take known and unknown patient characteristic into account.  Some of the unaccounted characteristics could affect the patient’s blood clot risk.  This results in an inconsistent estimate of what percentage the risk of blood clot is while taking birth control, such as Yaz or Yasmin, that contain drospirenone.

The revised drug labels for Yaz, Yasmin, Beyaz and Safyral will now state that studies did report as much as a three times greater risk of blood clots than pills containing different types of progesterone, such as levonorgestrel.

“At this time, healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.Additionally, adverse events involving drospirenone- containing products should be reported to the FDA”,  states the FDA website.