Yaz, Yasmin Continue To Cause Concern, FDA Says


The U.S. Food and Drug Administration (FDA) said it still “remains concerned” over drospirenone-containing birth control pills, such as Bayer’s Yaz and Yasmin, over reports of increased blood clot risks. The risks are apparently greater than those seen in other birth control pills.

The agency posted a Drug Safety Communication on its website yesterday in which it reported that early agency study results, from a study with 800,000 female participants, revealed a 1.5-fold increased risk for blood clots in women taking birth control pills such as Yaz and Yasmin, which contain drospirenone, said Fox News. Drospirenone is a type of progestin.

Drospirenone can elevate potassium levels in the body, which can lead to hyperkalemia in some patients; hyperkalemia can cause potentially serious heart and health problems. Oral contraceptives are generally made with the hormones estrogen and progestin and all do contain warnings concerning increased risks for blood clots; however, drospirenone-containing oral contraceptives—such as Yaz and Yasmin—appear to increase these risks significantly according to some published studies.

The FDA said it has not yet made a final conclusion concerning the blood clot risk with these drugs, but is scheduled to convene a medical expert panel on December 8th, said FoxNews.

In May, the FDA said that Yaz, Yasmin, and other drospirenone-containing contraceptives were being monitored over greater-than-typical blood clot concerns versus birth control bills made with another type of progestin.  The agency’s review followed two reports in the British Medical Journal that found a two- to three-fold greater risk of blood clots, including pulmonary embolism,in women taking oral contraceptives containing drospirenone versus those with the another synthetic progestin called  levonorgestrel.