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Birth Control Pills Containing Drospirenone

As of April 10, 2012, the FDA has completed its review of recent studies regarding the risk of blood clots in women taking birth control pills which contain drospirenone, which is a synthetic version of the female hormone progestin.  Based upon the findings of the study, the FDA has concluded that birth control pills which contain drospirenone can be associated with a much higher risk for blood clots than other birth control pills which contain progestin.  With the FDA findings come revised drug labels which report that studies show that there is a three-fold increased risk for blood clots when it comes to drospirenone containing contraceptives compared to contraceptives that contain levonorgestrel or other progestins whereas other epidemiological studies have found that there isn’t an additional risk of blood clots in products which contain drospirenone.  The intent of putting the findings of both of these studies on the labeling of these contraceptives is to show to the public the difference between other epidemiological studies and those which have been conducted by the FDA.  The revised drug labels of Beyaz, Safyral, Yasmin and Yaz show the findings of the studies.

Women who take contraceptives containing drospirenone have a 6 to sevenfold risk of developing thromboembolism compared to women who don’t take any contraceptives at all.  It has been also shown that women who take birth control pills containing drospirenone are at a twofold risk of developing thromboembolism than women who take birth control containing levonorgestrel.  In high risk patients, taking pills which contain drospirenone can potentially cause hyperkalemia.

Drospirenone is contraindicated in women with hepatic dysfunction, adrenal insufficiency, renal insuffiency or in women whose use of contraceptives are contraindicated due to smoking, deep vein thrombosis, stroke or other blood clots.  In drugs that increase potassium levels, concurrent use with contraceptives containing drospirenone need to be carefully managed.  These prescriptions include ACE inhibitors, potassium-sparing diuretics, potassium supplementations, angiotensin-II receptor agonists, heparin, aldosterone antagonists and NSAIDs.

The FDA is actively cautioning women to talk with their respective healthcare professionals about their own risk of blood clots before deciding which method of contraceptive birth control to use.  Healthcare professionals are being advised by the FDA to tell their patients the risks and benefits of drospirenone containing contraceptives.  It is also worth noting that in September of 2009, the FDA cited the drug company Bayer for sending out potentially low quality batches of drospirenone which Bayer had justified by saying that they just monitor the “average” quality of all of their shipments, while not assessing the quality of each individual batch.