Yaz and Yasmin revise labels after FDA review

Yaz and Yasmin revise labels after FDA review

Posted By The Maher Law Firm || 25-Apr-2012

Yasmin Birth Control

Yaz and Yasmin Birth Control Risky Due to Drospirenone

The U.S. Food and Drug Administration (FDA) has completed its review of studies 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 known as a progestin. The study concludes that birth control pills containing drospirenone may put users at a higher risk of blood clots than other birth control pills that contain other progestins. Drospirenone is found in Yaz, Yasmin and Ocella.

The study did not take known and unknown patient characteristic into account, however. 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 FDA ordered revised drug labels for Yaz, Yasmin, Beyaz and Safyral to now state that some studies report pills containing drospirenone have as much as a three times greater risk of blood clots than pills containing different types of progesterone, such as levonorgestrel. Other studies have shown no correlation between drospirenone and blood clot risks.

"At this time, health-care 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.

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