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FDA Modifies Warning on Blood Clot Risk From Drospirenone Birth Control Pills

FDA Modifies Warning on Blood Clot Risk From Drospirenone Birth Control Pills

April 11, 2012 — FDA on Tuesday announced that the labels for birth control pills containing the hormone drospirenone must now state that studies have shown they might increase the risk of blood clots by up to three times more than other progestin-containing birth control pills, MedPage Today reports (Gever, MedPage Today, 4/10).

The label change follows advice from an outside panel of experts, which in December recommended clearer warnings for pills containing drospirenone (Corbett Dooren, Wall Street Journal, 4/10).

FDA stopped short of saying that drospirenone definitely raises the risk of blood clots, noting that the "studies reviewed did not provide consistent estimates of the comparative risk of blood clots" from pills that contain the ingredient and those that do not.

The revisions apply to the brand-name contraceptives Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz and Zarah, as well as two generic formulations (MedPage Today, 4/10). According to the AP/USA Today, drospirenone birth control pills are among the most popular oral contraceptives in the U.S., largely because they are advertised to clear up acne and alleviate other hormone-related issues (AP/USA Today, 4/10).

FDA noted that all women who use birth control pills have a higher risk of blood clots than women who do not take the pills. However, the risk of taking any type of birth control pill is lower than the risk of blood clots during pregnancy or the postpartum period, according to the Journal.

FDA said women should discuss their risk of blood clots with their health care provider when deciding on a birth control method. Doctors should assess a woman's risk for blood clots before prescribing oral contraceptives, the agency added.

Bayer -- the maker of Beyaz, Safyral, Yasmin and Yaz -- said in a statement that it agrees with FDA's decision (Wall Street Journal, 4/10).