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Information on Beyaz Lawsuits

Beyaz is Bayer’s attempt to capitalize on the unprecedented level of direct-to-consumer advertising that it did with Yaz, while distancing itself from the controversy involving Yaz – allegations that Yaz/Yasmin/Ocella causes deep vein thrombosis (blood clots), pulmonary embolism (PE), strokes, heart attacks, gallbladder problems, and other complications for women. Bayer also has taken other hits on Yaz as well, getting smacked by the FDA for some awful Yaz advertising. Bayer is cynically/wisely trying to keep its birth control dynasty going while distancing itself from Yaz.

So far, so good for Bayer. Bayez gained approval from the FDA on September 04, 2010 for its contraceptive and anti-acne ability. In 2011, it is reported that sales of Beyaz were approximately $97 million. This will be peanuts once Bayez pushes Yaz fully out of the way.

What is the difference between Beyaz and Yaz? Not much. Beyaz adds a little folic acid (vitamin B-9) to the Yaz formula. Sure, a little B-9 can’t hurt. It’s an important nutrient that contributes to many of the body’s functions, particularly during pregnancy. So, that’s nice, I guess, Bayer is improving its formula for the rare instances where Beyaz does not work and a woman gets pregnant. That’s pretty smart. This combination pill would reduce the risk of neural tube defects in a pregnancy conceived while on the pill or soon after discontinuing it.

But the problem is that Beyaz still contains Drospirenone which seems to be the problem that is causing these injuries. Drospirenone has been reported in two studies published in the British Medical Journal (BMJ) to have a higher risk of blood clot formation compared to other birth control pills (see here and here). An increase in risk of blood clot formation may increase risk for more severe problems such as heart attacks, stroke, or more seriously, death. The risk of blood clot formation is estimated to be 1.5 to 3 in every 10,000 women annually.

The studies reported in the British Medical Journals prompted a review by the FDA. As drospirenone was shown to have a 2- to 3-fold increase in risk of venous thromboembolic events (VTEs) compared to levonorgrestel containing oral contraceptives. The FDA study includes over 800,000 women with the objective of comparing a number of hormonal contraceptives with respect to thrombotic and thromboembolic risks including VTE, but have not yet reached a firm conclusion with the exception that they have acknowledged the numerous studies showing an increase in risk of VTEs associated with oral contraceptives containing drospirenone. I think the weight of the evidence is overwhelming – I’m not sure what the FDA is waiting for. The marketplace agrees; Yaz sales have dropped considerably.

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