FDA Safety Warnings Change for Birth Control Pill

Drospirenone containing birth control pills get new FDA warnings for higher risk of blood clots

(RxWiki News) The U.S. Food and Drug Administration (FDA) issued a safety warning for birth control pills containing drospirenone. Birth control containing this synthetic hormone may put women at increased risk for blood clots.

On April 10, 2012, the FDA published an updated safety warning after review of evidence that showed that some women may be at increased risk of blood clots when taking pills containing dorspirenone, such as Yaz, Yasmin, or Ocella. Labels for these products will be updated with the new safety recommendations.

"Discuss your birth control options with your gynecologist"

Drospirenone is a synthetic hormone that simulates natural progesterone. It is found in a variety of birth control pills and some types of hormone replacement therapies for menopause.

The FDA reviewed evidence from some studies showing that the risk of blood clots for women taking pills containing drospirenone was three times that of the risk of blood clots for women taking other types of synthetic progesterone.  Other studies they reviewed showed no increase in the risk of blood clots compared to other the options.

After review of the evidence, the FDA issued a new safety warning and a label change to reflect the new warning. The FDA recommends that patients and their doctors discuss the risk factors for blood clots before taking birth control pills containing drospirenone.

The FDA warning was published online as part of the FDA’s Medwatch program that serves to monitor adverse events associated with medications.

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Review Date: 
April 11, 2012