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Tuesday, October 04, 2011

Dangers of Yasmin/Yaz/Ocella

Yasmin is a type of birth control originally developed by Berlex Laboratories (a U.S. affiliate of Schering AG, Germany) that was first approved for use in 2001. In 2006, the drug company, Bayer, acquired Berlex and marketed a more recent version of Yasmin, called Yaz. Ocella is a generic version.

Yasmin/YAZ/Ocella contains two types of hormones: an estrogen and a progestin. The estrogen is “ethinyl estradiol.” The progestin is “drsp” or “drospirenone”. Yasmin/YAZ/Ocella is the first type of birth control to contain drsp. Yasmin contains 3 mg drsp and 30 mcg ethinylestradiol per tablet. YAZ contains 3 mg drsp and 20 mcg ethinylestradiol per tablet. The drug prevents ovulation by working against the usual body chemistry of a woman of childbearing potential by suppressing endogenous gonadotropins and, thereby, inhibiting ovulation and altering other changes associated with the menstrual cycle.

The manufacturers of Yasmin/YAZ/Ocella have touted its latest creation as a “pill that goes beyond the rest,” and promises multiple additional benefits above and beyond unwanted pregnancies. They also claim that this latest drug creation is as safe as other types of accepted birth control pills that are on the market. In light of these promises made in slick advertising campaigns, the new product has made Bayer/Berlex millions of dollars. For example, in 2008, sales of YAZ reached $616 million (an approx. 18% U.S. market share), and Yasmin sales reached $382 million (an approx. 11% U.S. market share). It is now the best-selling oral contraception pill in the United States.

However, in putting the interest of corporate profits over public safety, Bayer/Berlex’ advertisements have focused almost exclusively on the positive affects of its newest drug creation. It has continually omitted or minimized the very significant risks associated with or increased by the novel drug, including heart attacks, cardiac arrhythmias, blood clots, deep vein thrombosis (DVT), pulmonary embolism (PE), strokes, gallbladder disease, hepatic adenomas or benign liver tumors, and other serious injuries and sudden death. These life-threatening risks include, but are not limited to, those risks that Bayer knew or should have known are associated with or increased by the unprecedented use of this new hormone, drsp.

Bayer has also improperly encouraged the use of Yasmin/YAZ/Ocella in circumstances other than those in which the drug has been approved and over-stated its benefits. In fact, the U.S. Food and Drug Administration (FDA) has repeatedly reprimanded Baxter/Berlex for marketing the drug in a way that minimizes these very serious side effects, thereby misleading millions of women and their prescribing physicians about the safety of this new type of birth control.

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