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

Bayer Schering Pharma has announced it will update the label in the European market for its oral contraceptive Yasmin, a combination of ethinylestradiol and the diuretic drospirenone, also known by the brand name Yaz and the generic brand Ocella. The new label will include results of four epidemiological studies conducted by independent investigators that show the risk for venous thromboembolism, or blood clots, in Yasmin users is comparable to the risk found for women who use levonorgestrel-containing oral contraceptives.

“Yasmin’s positive benefit/risk profile remains unchanged. Our wealth of post-marketing safety data includes more than 42 million women with years of drospirenone use, as well as two epidemiological studies involving more than 120,000 oral contraceptive users. We are convinced that Yasmin is a good choice for women seeking convenient and reliable contraception if they use the product as directed. Bayer will continue to provide information which will support health care providers and their patients in taking informed decisions about appropriate treatment choices,” said Kemal Malik, MD, Chief Medical Officer at Bayer Schering Pharma, in a press release issued by the drug company.

The news is hardly reassuring for the hundreds of women who have been injured by Bayer’s Yasmin who have filed lawsuits in both the United States and Canada. They contend that flashy advertisements from the company downplayed the serious side effects of the drug, and that its formulation with the added diuretic made women more susceptible to suffering gallbladder problems, blood clots and other serious ailments. After strict orders and a stiff penalty by the Food and Drug Administration, Bayer has since bankrolled another advertising campaign aimed at clarifying its approved usages and explaining the serious side effects it may cause.

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