Yasmin: An Overview of the
Product and Its Dangers

 

Yasmin

Yasmin is the brand name of an oral contraceptive manufactured by Bayer HealthCare and approved for use in the United States by the Food and Drug Administration since 2001.

Like many oral contraceptives, Yasmin is a combination of two drugs. The combination of two specific substances, ethinylestradiol and drospirenone, in a single formulation is what defines Yasmin as a brand of contraceptive.

Ethinylestradiol is a synthetic estrogen that has been approved since 1943. It is used in varying dosages as a component of most combined oral contraceptives. Ethinylestradiol acts as a contraceptive both by inhibiting ovulation and by causing the cervical mucus to thicken, which keeps sperm and egg from joining.

The second component of Yasmin, drospirenone, is a synthetic progestin. As such, it is related to the naturally occurring hormone progesterone, which prevents ovulation during pregnancy. Drospirenone acts as a contraceptive largely because it mimics the ovulation-inhibiting effect of the natural hormone. It also causes a thinning of the lining of the uterus, which contributes to the contraceptive effect by making it more difficult for an embryo to be implanted.

In addition to its use for the purpose of contraception, Yasmin has been marketed by Bayer as a treatment for premenstrual syndrome and for severe acne.

Yasmin is distributed in pill form, with a medication regimen of 21 active pills and seven inactive pills taken over a 28 day cycle that conforms to the normal menstrual cycle. The active pills contain 3 mg of drospirenone and 0.03 mg of ethinylestradiol.

Yasmin and the family of similar oral contraceptives produced by Bayer have been the company's best selling and most profitable line of pharmaceuticals.

DANGERS

Yasmin is distributed with literature detailing a variety of side effects associated with its use. Side effects range from those characterized as minor and common to severe side effects requiring immediate medical attention.

Among the severe side effects listed in Bayer's warnings to patients are: allergic reactions; breast lump or discharge; leg pain or swelling; chest pain; left-sided jaw, neck, shoulder or arm pain; persistent insomnia; coughing up blood; numbness of an arm or leg; weakness on one side; swollen hands, fingers, legs or ankles; and various symptoms of liver problems.

More generally, estrogen related medications like ethinylestradiol have a long and well-documented history of increasing the risk of blood clots, known technically as thrombosis, in the lungs and legs. These problems are related to the part played by estrogen in blood coagulation. Drug companies have responded to this known risk by attempting to decrease the quantity of ethinylestradiol in contraceptive formulations. Yasmin has been characterized as a formulation containing a moderate dose of ethinylestradiol when compared with similar medications.

Questions have been raised by some medical researchers and by Yasmin attorneys about dangers associated with the particular combination of ethinylestradiol and drospirenone used in Yasmin. These inquiries focus on an increased risk of blood clots leading to pulmonary embolism, stroke and heart attack, and on the issue of whether Bayer provided sufficient warnings to patients about those risks.

A Bayer-funded study that compared Yasmin with a drug containing a different progestin, one that has been in use since the 1970's, found no increase in risk for patients taking Yasmin. Yasmin attorneys and health advocates, however, point to two more recent European studies that implicate drospirenone, among other newer progestins, in an increased risk of blood clots.

While the mechanism behind any increased danger from taking Yasmin is not well understood, the results of a medical study published in 2009 found increased levels of copper in the blood of patients taking Yasmin when compared to a control group of women not taking contraceptives. Higher levels of copper correlate with an increased risk of death from heart disease. This followed a 1998 study which found higher levels of copper in users of contraceptives containing progestins related to drospirenone.

The situation is complicated by Bayer's marketing campaign, which portrayed Yasmin as part of a family of life-style drugs. The FDA issued a warning letter that characterized the ads as false and misleading, claiming that they minimized the dangers of the drug, overstated its effectiveness and marketed it for purposes that had not received FDA approval.

In response, Bayer launched a series of corrective ads meant to counter the misleading message of the original campaign.

More recently, the FDA has issued a second warning letter. This letter alleged that Bayer failed to comply with quality standards in a German facility that manufactures drospirenone and other hormones included in contraceptive pills sold in the United States. Specifically, the FDA maintained that Bayer had failed to meet American standards that regulate allowable variability in ingredients used to produce pharmaceuticals.