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New Birth Control Label Warns of Increased Blood Clot Risk
- Ennis & Ennis
04/11/2012 - The U.S. Food and Drug Administration (FDA) has completed its review of studies involving drospirenone-containing birth control pills, such as Yaz and Yasmin and has concluded that these types of birth control pills increase the risk for dangerous blood clot. As a result, the FDA is requiring a label change to include this information.
The revised label will address that studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing birth control pills when compared to “older generation” birth control pills containing levonorgestrel or some other progestins.
The FDA’s decision follows the recommendation from an advisory panel that met in Decemeber, voting 21-5 that labeling on Bayer’s Yaz birth control pill is inadequate and should be revised to better reflect the higher risk of blood clots associated with these drugs.
The increased blood risk is well substantiated. The most recent findings include three studies which were released within a two-week time period at the end of 2011. On October 25, 2011 The British Medical Journal published a study confirming previous findings that oral contraceptives containing newer types of progestogen hormones (drospirenone, desogestrel or gestodene), which are found in Yaz or Yasmin, at least double the risk of developing venous thromboembolism (VTE), compared to oral contraceptives with an older progestogen hormone (levonorgestrel). Then, interestingly enough, on October 27, 2011 the FDA released their own independent study findings confirming the popular birth control pills, Yaz and Yasmin, increase blood clots risks by almost 74%. Then on November 7, 2011 The Canadian Medical Association Journal released a study revealing the risk of blood clots was 65 percent higher among drospirenone users than among women taking second-generation contraceptives containing levonorgestrel and norgestrel.
The FDA recommends that women speak with their healthcare professional about their risk for blood clots before deciding which birth control method to use.
The FDA further recommends that 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.
Yaz - Yasmin Side Effects Lawsuit:
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