Yaz Problems Continue to Arise
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Lawsuits against Bayer, the manufacturer of Yaz, continue to be filed across the United States by women who have suffered serious health issues, which may have been caused by the drug. Yaz is a combination hormone contraceptive containing the hormones ethinyl estradiol (estrogen) and drospirenone which is a synthetic form of progestin. In the drug world, Yaz is commonly referred to as “fourth generation” birth control pill, because of its composition, and is markedly different from its earlier counterparts because it contains drospirenone.
These lawsuits follow warning letters from the Food and Drug Administration to Bayer in 2008 concerning false claims being made in their advertising (Bayer agreed in February 2009 to spend $20 million on a corrective ad campaign to address the FDA concerns), admonishments to fully disclose risks associated with the use.
While Bayer vigorously defends its product (why wouldn’t it, when Yasmin, Yaz and Yasminelle contraceptives brought in $1.86 billion for Bayer in 2008 alone), their legal woes continue to mount. Yaz has recently been tied to an increase in the risk of several health issues, including blood clots (deep vein thrombosis and pulmonary embolism), gallbladder problems, heart attacks and strokes for women using the pill.
Many of the lawsuits have been filed by women who have suffered from blood clots; gallbladder problems including gallstones, infection, inflammation (cholecystitis), obstructions and even gallbladder removal (cholecystectomy) are being more frequently reported in recent months. Symptoms of gallbladder disease include abdominal pain, chest pain under the breastbone, fever and chills, heartburn, nausea and vomiting.
It is still unknown whether it is the combination of estrogen and drospirenone which is causing the problem or it if is the drospirenone itself which is the culprit. While it has long been known that the use of oral contraceptives can lead to an increased risk in clotting, the reports from women who have experienced health issues while taking Yaz are arising in otherwise healthy women with no other risk factors and the problems are appearing following a relatively short period of use.
Two medical research studies, conducted in the Netherlands and Denmark and recently published in the British Medical Journal, appear to support the hypothesis that use of oral contraceptives leads to increased risk of blood clots – particularly where the levels of estrogen are higher. The only study which contradicts the conclusions of these researchers is one sponsored by, and paid for, by Bayer itself. Yaz uses drospirenone as its progesterone ingredient and the Dutch study found that there was a 6.3-fold increase in VT risk for drospirenone.
The problems associated with Yaz are not limited to women in the United States. The death of a Swiss woman, who died from complications arising from a pulmonary embolism while taking the birth control pill Yaz, is being investigated by the government of Switzerland. Swissmedic, the central supervisory authority for therapeutic products in Switzerland, making it the Swiss equivalent to our Food and Drug Administration, announced earlier this week that it is investigating the “sudden” death of a woman who had been taking the contraceptive for less than one year.