The US Food and Drug Administration (FDA) has issued a warning about Safyral birth control and other contraceptives that contain drospirenone, following concerns about drospirenone side effects. According to a document issued by the FDA, the risk of serious Safyral side effects, including a reported increased risk of blood clots will now result in strengthened warnings on the Safyral label.
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Drosperinone Warning
In September, the FDA issued a warning that the use of contraceptives that contain drospirenone is possibly linked to an increased risk of blood clots (09/26/11). The announcement came following a review of two recent studies, which evaluated the risk of blood clots in women who use drospirenone-containing medications. Furthermore, preliminary results from an FDA-funded study evaluating the risks of blood clots in women who use hormonal birth control products suggest that women who use a contraceptive that contains drospirenone have approximately 1.5 times the risk of blood clots compared with women who use other hormonal contraceptives.
"All birth control pills pose a risk of blood clots," the FDA stated (09/26/11). "Several epidemiological studies have reported that the risk of blood clots for women who use birth control pills containing drospirenone is higher than that for women who use birth control pills containing the progestin levonorgestrel. Other studies have not reported an increase in risk."
Safyral Side Effects
On December 9, 2011, the FDA convened an advisory panel to discuss the potential Safyral side effects and side effects of other birth control that contained drospirenone. The panel voted 15 to 11 to allow such birth control to remain on the market, but voted that the birth control should receive stronger labels regarding the possibility of serious side effects.
Blood clots can cause serious injury, especially if they break loose from the patient's vein and move to the patient's lung, where they can cause a potentially fatal pulmonary embolism. According to the FDA, two recently published studies found an increased risk for blood clots in women taking drospirenone-containing pills compared with women taking levonorgestrel-containing pills.
According to a study published in the British Medical Journal (04/21/11), women who use birth control that contains drospirenone have approximately three times the risk of developing a non-fatal idiopathic venous thromboembolism as women who use contraceptives that contain levonorgestrel.
"This study adds to the emerging evidence that use of the oral contraceptive containing drospirenone is associated with a higher risk of venous thromboemolism than are preparations containing levonorgestrel," researchers wrote. Furthermore, researchers said there is no clear evidence that drospirenone pills have increased benefits compared with contraceptives that contain levonorgestrel, making drospirenone a less than ideal first line contraceptive.
Meanwhile, a second study published in the British Medical Journal (04/21/11) found that woman who used birth control that contained drospirenone had approximately double the risk of non-fatal venous thromboembolism as women who used a birth control that contained levonorgestrel.
Drospirenone Birth Control Pills
Other birth control that contains drospirenone includes Yaz, Yasmin and Beyaz.
Drospirenone is a type of female hormone called progestin. It has been linked to an increased risk of blood clots in some studies. Safyral was approved by the FDA on December 17, 2010, as an oral contraceptive. The drug includes drospirenone and folate, similar to Beyaz, but in different amounts. Safyral is manufactured by Bayer HealthCare Pharmaceuticals, Inc.
Lawsuits have been filed against drugmakers who manufacture birth control with drospirenone as an active ingredient. Allegations have been raised in some court documents that Bayer did not notify the FDA of all cases of blood clots linked to drospirenone-containing birth control before the drugs were approved for use.
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Last updated on Apr-3-12 |
SAFYRAL ARTICLES AND INTERVIEWS
Did Suspected Advisory Panel Bias Affect Safyral et al Vote?
 Washington, DC: Given that the new-age contraceptive Safyral contains drospirenone (DRSP) and estradiol (EE), it is not surprising to see that the Bayer-manufactured product was tagged with the same concerns—and label updates—as other products in the Bayer family containing that specific formulation.
C [READ MORE]
FDA Requests Updates to Safyral Label
 Washington, DC: Along with other birth control medications that are caught up in the drospirenone side effects debate is Safyral, a birth control that contains drospirenone and also includes a supplement to help increase levels of folate in women who use the birth control. Concerns about Safyral side effects, brought about because of drospirenone, have resulted in the US Food and Drug Administration (FDA) requesting an update to the contraceptive's label [READ MORE]
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