Why did an advisory panel of experts for the Food and Drug Administration (FDA) not vote to ban the popular birth control pill Yaz and other pills of its generation containing the hormone drospirenone, instead opting to recommend that the pills carry a stronger warning for life-threatening blood clots?
Two new studies showing an increased risk in venous thromboembolism (VTE), or blood clots in the lungs, in women who use Yaz birth control pills and oral contraceptives with similar hormone formulations, has resulted in a special drug safety notification from the Food and Drug Administration (FDA). Yaz, made by Bayer, contains the progestin drospirenone. The same hormone is used in Bayer’s Yasmin, Beyaz and Safyral, as well as generics such as Ocella, Gianvi, Loryna, Syeda, and Zarah.
Women who use birth control pills are at greater risk for developing blood clots during the first six months of oral contraceptive use, and they are at even greater risk when first starting the pill and when restarting the same pill or a different pill after a four-week or greater break.
Another contraceptive for women is finding its way into the courtroom, following in the footsteps of Bayer Healthcare’s Yaz pill and Johnson & Johnson’s Ortho Evra patch. This time Merck & Co. Inc., is facing a slew of lawsuits over the drug company’s Nuvaring. Plaintiffs claim that the “first and only, once-a-month vaginal birth control ring” is more dangerous than older and equally effective products on the market and has caused them to develop life-threatening blood clots.
Swissmedic, the Swiss Agency for Therapeutic Products, has closed its formal investigation into contraceptives containing drospirenone, following the death of one young woman and of another woman who is now severely disabled. The agency says that although the risk of thrombosis, or blood clots, is higher with this generation of contraceptives, the risk remains “within reasonable limits.” Swissmedic says the drug will remain on the market there but the drugs are required to have updated information on their label to reflect an increased risk of serious injury.
Bayer Schering Pharma has announced it will update the label in the European market for its oral contraceptive Yasmin, a combination of ethinylestradiol and the diuretic drospirenone, also known by the brand name Yaz and the generic brand Ocella. The new label will include results of four epidemiological studies conducted by independent investigators that show the risk for venous thromboembolism, or blood clots, in Yasmin users is comparable to the risk found for women who use levonorgestrel-containing oral contraceptives.
