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

As Bayer HealthCare begins defending itself against a flurry of lawsuits citing health problems over its blockbuster birth control pills Yaz and Yasmin, the drug company announced it has received approval from the Food and Drug Administration (FDA) on a new oral contraceptive. Bayer’s Natazia combines the hormones estrogen and progestin in doses that adjust four times throughout a women’s menstruation cycle. Natazia is the first birth control pill to use the four-phase dosing protocol with the added benefit of controlling irregular bleeding better than other pills.

Like Natazia, Yaz and Yasmin were considered a new type of birth control pill. Yaz was approved by the FDA in 2006; Yasmin was approved in 2001. Both pills combine ethinyl estradiol and drospirenone, a diuretic not found in any other birth control product. The pills are marketed for the added benefit of treating severe acne and premenstrual dysphoric disorder, or PMDD. Both Yaz and Yasmin soared to the top spot on Bayer’s pharmaceutical sales list, bringing it more than $600 million in 2008 alone. It seemed almost too good to be true.

Then came the reports of serious injuries in women who took Yaz and Yasmin. The diuretic was believed to raise the potassium in women’s blood to dangerous levels, causing blood clots to form. Serious adverse event reports began pouring in, including heart attack, cardiac arrhythmias, stroke, pulmonary embolism, kidney failure, seizures, deep vein thrombosis (DVT), gallbladder disease, hepatic adenomas and even sudden death. The company now faces hundreds of lawsuits from women who say they were not adequately warned by Bayer of the serious health risks with using Yaz or Yasmin.

Prior to approval, two studies were conducted on the effectiveness of Natazia with a sample of 1,867 women. The most common side effects reported were irregular bleeding, headaches, nausea and vomiting.

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