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Oral contraceptives containing drospirenone: a potentially increased risk of blood clots.

10/13/11
US Food and Drug Administration USA (FDA) continues to study the safety of oral contraceptives containing drospirenone, in terms of the risk of blood clots.

However, definitive conclusions about the safety of these drugs have not been officially presented, the first research findings become contradictory.

Drosperinone is a synthetic progestin, used predominantly in hormonal birth control pills. The compound is part of certain newer oral birth control formulations:

  • Yasmin contains 3 mg drospirenone and 30 mcg ethinylestradiol in one tablet. It is indicated for the prevention of undesirabe pregnancy.
  • Yasminelle contains 3 mg drospirenone and 20 mcg ethinylestradiol per tablet and is used also used for contraception.
  • Yaz contains 3 mg drospirenone and 20 mcg ethinylestradiol and is given for 24/4 days for birth control as well.
Yasmin - birth control pills

Yasmin - hormonal birth control pills

FDA completed a review of these two recent studies carried out in 2011, and is currently evaluating the results of clinical trials conducted by the FDA. Preliminary results of a study initiated by the FDA show an increase of the risk of blood clots by about 1.5 times in women taking oral contraceptive with drospirenone compared with women receiving other hormonal birth control pills.

Taking into account the contradictory data obtained from previous clinical studies, FDA will continue to analyze this information. There will be held a meeting on 8th of December with the participation of the Committee on Safety of Medicines and Reproductive Health Drugs Advisory Committee, where the final conclusions about the potential risks and benefits of dropsperinone will be given.


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Oral contraceptives containing drospirenone: a potentially increased risk of blood clots.

US Food and Drug Administration USA (FDA) continues to study the safety of oral contraceptives containing drospirenone, in terms of the risk of blood clots.

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