FDA:Yaz or Yasmin, containing Drospirenone, Associated With Higher Blood Clot Risk
April 10th, 2012 tmccoy
If you are an OBGYN, Family Practice Doctor, or a young woman, you need to stop what you are doing and read this right now.
The FDA has just completed its review of recent observational (epidemiologic) studies on the risk of blood clots in women taking birth control pills that contain drospirenone. Based on this review, the FDA concluded that there is a possibility that drospirenone-containing birth control pills are associated with a higher risk for blood clots than other progestin-containing pills.
Yasmin, Yaz and Ocella are all birth control pills that contain drospirenone.
What is drospirenone?
It is a synthetic version of the female hormone, progesterone, a type of progestin. The FDA plans to add information about these new findings to the labels of drospirenone-containing birth control pills.
What will the new labels say? According to MedWatch, the revised drug labels will say:
- Some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins,
- Other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.
Source – MedWatch The FDA Safety Information and Adverse Event Reporting Program
