Product News and Recalls

FDA: Bayer must warn of Yaz/Beyaz increased blood clot risk

The U.S. Food and Drug Administration announced on April 10 that it’s changing the labels of birth control pills containing the compound drospirenone, adding information to warn users that numerous studies found as high as a three-fold increase in the risk of blood clots from those pills compared to other contraceptives on the market.

“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,” the FDA said in a statement.

The findings reflect 10 different studies evaluating the risk of those pills that contain drospirenone, compared to those that do not.

The majority of studies found that the pills with drospirenone do carry a higher risk of blood clots than those without it. The only studies that found no such higher risk were those funded by the manufacturer. And even those studies were unable to disprove the existence of a higher risk beyond the margin of error.

The FDA lists the following brand names for approved oral contraceptives containing drospirenone: Beyaz, Yaz, Yasmin, Ocella, Gianvi, Loryna, Safyral, Syeda, and Zarah.

See the FDA’s release here: http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm