Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Last month, an advisory panel for the Food and Drug Administration (FDA) pored over data that showed women who took birth control pills containing the hormone drospirenone were at greater risk of developing blood clots than women on older generation birth control pills. Yet, panel members refused to ban the drug, instead recommending that the FDA put stronger warnings on the pills’ labels. Why would the panel have such lax standards when it comes to the safety of American women? One watchdog group is suggesting that the panel, which included four advisers with ties to companies that make drospirenone-containing drugs, may have been unfairly slanted.

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Women who take birth control pills with the hormone drospirenone, such as Yaz and Yasmin, are at greater risk of gallbladder damage than women on other oral contraceptives, according to a new Canadian study. The new research involved 2.7 million women who took birth control pills for at least six months between 1997 and 2009. A total of 27,087 women in the study group underwent surgery to have their gallbladders removed. The study found that while all birth control pills put women at some risk for losing their gallbladders, women who use pills with drospirenone were at greater risk.

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The Food and Drug Administration (FDA) has approved a generic version of two brand-name birth control pills. Emoquette, made by Huntsville, Ala.-based Qualitest Pharmaceuticals, contains the same hormones, desogestrel and ethinyl estradiol, as Ortho-McNeil Pharmaceutical’s Ortho-Cept and Organon USA’s Desogen.

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Lana Speck didn’t know what had come over her when she began experiencing severe stomach pains in early 2006. Her doctor ordered a cholecystectomy, or the surgical removal of her gallbladder. But she continued to be plagued with even more problems, such as constant severe chest and upper abdominal pain. She also battled extreme diarrhea and indigestion.

Two years later her doctor made a connection. Lana had been taking Yaz or Yasmin birth control pills for seven years, since 2001. The pills have been linked to gallbladder damage, yet Lana says she was never warned of those risks by the pills’ manufacturer, Bayer Corp. Lana is now one of more than 2,000 women who have filed lawsuits against Bayer. The plaintiffs claim that Bayer was fully aware of the risks associated with use of the pills, yet the company did nothing to warn users.

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Two more women have filed lawsuits against the makers of Yaz birth control, alleging they were seriously injured after taking the oral contraceptives. They claim had they known the dangers associated with Yaz, they would have never risked their life by taking that type of birth control pill. Amie Nardone and Lauren Powell, both of New Jersey, say Yaz caused them to suffer gallstones and a blood clot, respectively.

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Bayer HealthCare has launched another birth control pill packed with the hormone ethinyl estradiol, the diuretic drospirenone, and the B vitamin folic acid. The new oral contraceptive, called SAFYRAL, follows by three months the introduction of Beyaz, a near-identical pill packed with the same active ingredients. Folic acid has been shown to protect unborn babies against neural tube defects if the vitamin is taken regularly by women before and during the first three months of pregnancy.

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Just one month after Susan Gallenos began taking the birth control pill Yaz, she nearly lost her life to a stroke. Half her skull was removed to ease the pressure on her swelling brain. She would never be the same again. Her doctors blamed her birth control pill.

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When Katie Ketner was 15, she met with a gynecologist about birth control. The doctor told Katie that Yaz “helped people regulate their menstruation, helped people control their acne, and things like that,” Katie remembers. The ads for Yaz were everywhere then, colorful commercials with smiling women praising the pill that not only prevented pregnancy, but also squashed irritability and moodiness associated with premenstrual syndrome as well as cleared up bothersome acne. It was an easy sale for Katie.

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When the Food and Drug Administration approved for marketing a version of Bayer’s Yaz birth control pill fortified with folic acid, known as Beyaz, the public took notice. Why pack a vitamin shown to reduce birth defects of the brain and spine in a pill that prevents pregnancies? The answer was that while the pill has a 99.9 percent effective rate, not all women take the pill perfectly.

But folic acid also offered other benefits, some experts claimed. Since folic acid lowers blood levels of the protein homocystine, which is linked to heart and blood vessel disease and other medical problems, some scientists suggested that the B vitamin could also lower the risk of heart disease, stroke or cancer.

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The Food and Drug Administration (FDA) may have granted permission to drug companies to market generic versions of Bayer’s blockbuster birth control pills Yasmin and Yaz, but Bayer is not giving up its fight to prevent other companies from taking a bite out its profits. The German drug company said Wednesday it will continue trying to protects its patents on its pills despite a New York judge’s dismissal of Bayer’s latest patent infringement lawsuit late Tuesday against Watson Pharmaceuticals and Sandoz.

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