{"id":540344,"date":"2010-04-22T17:55:00","date_gmt":"2010-04-22T21:55:00","guid":{"rendered":"tag:typepad.com,2003:post-6a00d8341c89dd53ef0133eca157db970b"},"modified":"2010-04-22T18:03:03","modified_gmt":"2010-04-22T22:03:03","slug":"is-bayer-warning-or-attacking-with-its-new-yaz-yasmin-package-insert-or-label-in-the-u-s","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/540344","title":{"rendered":"Is Bayer Warning Or Attacking With Its New YAZ \/ Yasmin Package Insert, Or Label, In The U.S."},"content":{"rendered":"
\n

Bayer Says YAZ \/ Yasmin Safety Profile Is Comparable To Older Birth Control Pills, But European Regulators See\u00a0Possible Increased Risk Of Blood Clot Side Effects<\/span><\/span><\/span><\/strong><\/p>\n

(Posted by Tom Lamb at DrugInjuryWatch.com<\/strong><\/font><\/span><\/a>)<\/strong><\/font><\/strong><\/font><\/span><\/span><\/span><\/span><\/span><\/p>\n

On April 9, 2010 Bayer HealthCare Pharmaceuticals announced that that it will update the labels for YAZ\u00ae (3 mg drospirenone \/ 0.02 mg ethinyl estradiol) and Yasmin\u00ae (3 mg drospirenone \/ 0.03 mg ethinyl estradiol) in the United States.<\/p>\n

We have not seen the actual new YAZ \/ Yasmin package insert, or label, but the press release by which Bayer made this announcement, “BAYER UPDATES LABELS FOR YAZ and YASMIN — Body of Evidence Affirms VTE Risk\/Benefit Profile for YAZ and Yasmin Is Comparable to Other Combination Oral Contraceptives”<\/a>, makes us wonder whether Bayer is issuing it to warn doctors and patients or to attack medical researchers who have suggested that these\u00a0unique “fourth generation” pills containing the progestin drospirenone (DRSP) may be unsafe to use.<\/p>\n

From this April 2010 press release we get this “preview” of what the new YAZ \/ Yasmin label will state about this emerging drug-safety issue:<\/p>\n

\n

…the new labels now state:<\/p>\n<\/blockquote>\n

\n

\u2022 A prospective cohort study (EURAS), conducted in Europe, showed the risk of thromboembolism (particularly venous thromboembolism) and death in Yasmin users to be comparable to that of oral contraceptive preparations, including those containing levonorgestrel.<\/p>\n

\u2022 Another prospective cohort study (Ingenix), conducted in the USA, also showed a comparable risk of thromboembolism in Yasmin users compared to users of other COCs, including those containing levonorgestrel. In this study, COC comparator groups were selected based on having similar characteristics to those being prescribed Yasmin.<\/p>\n

As part of its evaluation of the risk\/benefit of YAZ and Yasmin, the FDA also reviewed data from one case-control study (van Hylckama Vlieg et al.) and one retrospective study (Lidegaard et al.) which suggested that the risk of venous thromboembolism occurring in Yasmin users was between the risk associated with levonorgestrel-containing COCs and desogestrel\/gestodene-containing COCs. Based on the FDA\u2019s review, the new labels now state that key conclusions from both studies are unreliable<\/strong>:<\/p>\n

\u2022 With regard to the case-control study, the label indicates that, \u201c\u2026the number of Yasmin cases was very small (1.2% of all cases) making the risk estimates unreliable<\/strong>.\u201d<\/p>\n

\u2022 Concerning the retrospective cohort study, the label indicates that, \u201cThe relative risk for Yasmin users in the retrospective cohort study was greater than that for users of other COCs when considering women who used the products for less than one year. However, these one-year estimates may not be reliable <\/strong>because the analysis may include women of varying risk levels. Among women who used the product for one to four years, the relative risk was similar for users of Yasmin to that for users of other COCs.\u201d<\/p>\n

[Footnotes omitted; emphasis added]<\/p>\n<\/blockquote>\n

So, essentially, it seems that Bayer is\u00a0claiming that YAZ and Yasmin are as safe as “second generation”\u00a0 birth control pills which contain the progestin levonorgestrel and that the following two medical journal articles\u00a0should be disregarded:<\/p>\n