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Oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer Healthcare, largely because the products’ marketing presents them as much more than just pregnancy prevention. In fact, the franchise had worldwide sales of $1.8 billion last year, based on Bayer successfully positioning the brands as the go-to medication for women under the age of thirty-five. Yaz, which contains less estrogen than Yasmin, is the top-selling birth control pill in the U.S., garnering much of its popularity from a multi-million dollar ad campaign that promotes the drug as one that combats acne and severe pre-menstrual depression.

Recently, however, the Yaz franchise has faced criticism from several researchers, trial lawyers and health advocates who fear the drugs place women at a higher risk for developing blood clots, strokes and other health problems, as opposed to other birth control medications; because the drug contains drospirenone, which can increase potassium levels in the body, it may put women who have liver or kidney problems at risk for serious heart problems. The critics of Yaz are up against a recent European study, sponsored by Bayer, which reported the opposite conclusion. This study claims the cardiovascular risks in women taking Bayer products that contain drospirenone were the same as those taking an older formula of birth control pills that contain levonorgestrel. One doctor, who is a paid consultant for Bayer, claims the risk of developing blood clots is far less in taking birth control pills than being pregnant and having a baby.

Despite Bayer’s report, regulators and other scientists are finding other problems with the company. For example, two other studies on Danish and Dutch women did find a higher risk of venous blood clots for women taking newer progestins, including drospirenone. One of the doctors who authored the Dutch study says the reports of an increased risk were worth acting on by switching the pills from drospirenone to levonorgestrel; he said, "Even if the risk of thrombosis is low, why not choose the lowest risk, just in case?" Earlier this year, the Food and Drug Administration (FDA) also asked Bayer to correct misleading television commercials that overstated the drug’s efficacy, promoted it for conditions for which the drug is not approved and minimized serious risks associated with the drug. In September, the FDA also cited the company for failing to follow proper quality control procedures at a German plant that makes drospirenone and other hormone ingredients

Attorneys suing Bayer on behalf of patients who claim they developed blood clots and other health problems due to the drugs are arguing the company knew or should have known the pills created a higher risk. One such patient has lost partial function in her right lung after developing a blood clot from the birth control pill; she claims to have not known there was a higher risk using Yaz than any other birth control pill. Because Yaz and Yasmin contain warnings on their packages about the risk of side effects like blood clots and strokes, it may be hard for plaintiffs to win lawsuits. The one ray of hope may be the argument that due to misleading Yaz commercials, women were enticed to take the drug, thereby becoming exposed to health risks they may not have otherwise incurred.

In response to a reporter’s inquiries, Bayer stated its birth-control pills had been and continue to be studied extensively and the company stands behind their safety. The drugmaker also claims to have responded to the FDA’s inquiry into its manufacturing practices. Even if Bayer can adequately respond to the safety and other concerns, some industry analysts believe the outpouring of criticism may tarnish Yaz’s line image. Bayer said it has been served with seventy-four lawsuits brought by women who claim to have developed problems after taking Yaz or Yasmin; the company says it will defend itself vigorously against the allegations. While the lawsuits may rattle some consumer confidence, the warnings from federal health authorities concerning quality control and advertising raise larger questions regarding Bayer’s compliance with government rules.

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