Bayer HealthCare has added new information on the labels of its blockbuster birth control pills Yaz and Yasmin to warn users that the risk of developing blood clots while taking the pills are similar to the risks with other oral contraceptives. The label change comes on the heels of hundreds of lawsuits filed both in the United States and Canada by women who say they were injured by Yaz or Yasmin but were not adequately warned of the risks associated with taking the pills. Bayer agreed to make the changes to the pills’ labels based on two large, multiyear studies of more than 120,000 women taking contraceptives in the U.S. and the U.K.
Yaz and Yasmin, as well as the generic Ocella, contain drospirenone, a diuretic that the plaintiffs claim elevated potassium in their bloodstream, which put them at greater risk for serious and sometimes fatal complications from blood clots, such as heart attack, pulmonary embolism, deep vein thrombosis and stroke. Diuretics can also cause significant problems with the gallbladder and may lead to gallbladder removal.
The lawsuits allege Bayer’s birth control pills put users at greater risk for serious adverse events; however, the company maintains that a woman’s risk of developing blood clots while taking Yaz or Yasmin is similar to other oral contraceptives.
Yaz and Yasmin were Bayer’s top-selling pharmaceutical last year, ringing in sales of $1.64 billion.