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news.Bayer Schering Pharma is planning to update its label for Yasmin (drospirenone / ethinylestradiol) in the EU to include results of four epidemiological studies. Bayer sponsored two large observational post authorisation safety studies (Euras and Ingenix) on combined oral contraceptive (COC) use for European and US (FDA) Health Authorities.
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Bayer Schering Pharma said that these prospective cohort studies conducted by independent investigators found that the risk for venous thromboembolism (VTE) in Yasmin users is comparable to the risk found for women who use levonorgestrel-containing COCs.
Bayer Schering Pharma is expected to update the European Summary of Product Characteristics for Yasmin with these results. At the request of the pharmacovigilance working party (PhVWP) of the Committee for Medicinal Products for Human Use (CHMP) two recently published retrospective studies (Lidegaard et al, van Hylckama Vlieg et al) will also be included in the update.
The two studies found the VTE risk in Yasmin users to be between the risk associated with levonorgestrel-containing COCs and desogestrel/gestodene-containing COCs. The results of one of these two studies were not statistically significant.
Epidemiologists as well as Bayer Schering Pharma, have identified several methodological issues in these recently published studies that need to be clarified before a final conclusion on Yasmin’s VTE risk can be made. Bayer Schering Pharma is working with the PhVWP on a reanalysis of some of these data.
Kemal Malik, chief medical officer at Bayer Schering Pharma, said: “Yasmin’s positive benefit/risk profile remains unchanged. Our wealth of post-marketing safety data includes more than 42 million women 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.”