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FDA Add New Side effect to Birth Control Pills Labels


FDA Add New Side effect to Birth Control Pills Labels

(ePharmaNews) - The U.S. Food and Drug Administration (FDA) has completed today its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills.

Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin.  
FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.  

FDA also announced safety tips that women should talk to their healthcare professional about, including their risk for blood clots before deciding which birth control method to use. FDA also stressed that healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk of developing a blood clot before prescribing these drugs.


The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not.  The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect on the risk of blood clots. 

For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills.


 Finally, it should be mentioned that this drospirenone-containing birth control pills exist in Arabian markets under the brand name “Yasmin”


اضغط هنا للقراءة باللغة العربية

Prepared by: Houssam Nahhas
Translated by: Marcell Shehwaro


Source :

ePharmaNews






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