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拜耳避孕药被指增患血栓风险 所涉产品中国在售
发布时间：2011-06-02      来源：中国新闻网
    据《纽约时报》6月1日报道，美国食品与药物管理局(FDA)正在针对德国制药企业拜耳医药(Bayer)所出产的优思明(Yasmin)等4款避孕药展开调查，以确定其是否比其他避孕药更能引起增患血栓的风险。截至发稿时，优思明在中国仍然在售。

　　今年5月上旬，拜耳医药在美遭遇诉讼。美国北卡罗来纳州一位18岁的女大学生在服用避孕药Yaz(香港名为优悦)后因心脏停搏而猝死，事后其死因被指与服用Yaz引发的血栓有关，随后死者父母将拜耳医药告上法庭。《英国医学杂志》此前发布的两份报告显示，相比传统避孕药，Yaz中含有的荷尔蒙屈螺酮成分会使服药女性患上血栓的风险提高两到三倍。

　　此次FDA调查的药物包括Yaz、Yasmin、Beyaz和Safyral四种，其中Yasmin(优思明)于2009年正式进入中国，由拜耳医药保健有限公司广州分公司生产，且以处方药的形式销售。据介绍，Yaz是优思明的低剂量版本，两者均主要面向35岁以下女性。

　　据法新社报道，上述死者家庭的律师指责Yaz是“一种在出售前没有进行任何可能产生严重患病风险提示的处方药”。而参与此次调查的调查者也认为，医生和患者应该密切注意可能出现的血栓病症状，包括腿部和胸部疼痛。

　　据媒体报道，针对FDA的调查，拜耳-先灵药业有限公司女性健康产品组中国市场负责人表示，拜耳认为FDA援引的两份报告中的结论不是很有根据，实验方法也有明显的缺陷。中新网生活频道记者对北京几家药房进行了走访，发现优思明仍然有售。药房工作人员均表示未听说过相关调查，也未接到任何相关通知。在优思明的药品说明书的“不良反应”栏目中，提到可能产生的不良反应包括子宫不规则出血、恶心和情绪波动，最严重不良反应为妊娠，并未提到任何与增患血栓风险有关的字样。

　　数据显示，Yaz系列避孕药去年销售额达到14.7亿美元，占拜耳公司全年利润的3.3%。

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