2015年4月13日讯/生物谷BIOON/- 对制药巨头辉瑞来说，最近日子并不太平。就在上周，公司斥资170亿美金收购的生物仿制药和注射液生产商Hospira因为一生产厂违反标准制药手续一事，收到了美国食品药物管理局(FDA)发出一封包含详细内容的警告信函。
今天，辉瑞公司的抗抑郁畅销药Zoloft又面临患者的起诉。由于媒体过度的关注和渲染报道，该诉讼对国际制药巨头辉瑞造成了大量负面影响。诉讼中表示，辉瑞公司提前知晓Zoloft药物能够导致怀孕期间服药的女性生育心脏缺陷的婴儿。这一副作用很容易在药物的临床实验中被发现，但是公司却故意隐瞒并顺利将药物推向市场。
证据表明，在去年同期，一些怀孕期间服用该药物的女性生育了具有先天异常疾病的婴儿。一些家庭已经正式向法院提交申请，起诉辉瑞没有及时将药物的危险副作用告知他们。由于担心公布该药物的副作用会造成销售额明显下降，辉瑞制药在明知其有潜在的危险的情况下，仍然决定继续在世界范围内大量推广该药物。
Joe Zonies律师是一个生育了心脏缺陷婴儿受害家庭的代表，他说辉瑞制药故意对医生和患者隐瞒了该药物的巨大风险，这是不负责的行为。不过辉瑞制药的做法也很容易理解，2005年开始，辉瑞已经从Zoloft收获了26亿美金的销售额，该药物也被认为是公司市面上最畅销的药物之一。
2006年后半年，该药物失去了专利保护，其仿制药正式进入市场，但是根据市场表现，Zoloft仍然非常受欢迎。去年辉瑞的Zoloft创造了4.33亿美金的喜人销售额。另一方面，辉瑞的律师坚持声称公司已经采取了所有必要的措施来避免该药物的副作用。
辉瑞公司的辩护人表示公司在药物上市前已经开展过足够和科学的实验进行测试。直到产品上市和在临床实验中，该药物没有显示出对婴儿的副作用，同时也没有科学数据能够证明Zoloft可以引起出生缺陷。
其实，这种情况不是首次发生，早在2010年，GSK因为抗抑郁药Paxil的副作用而面临过同样的起诉，由于导致孕妇服用后的婴儿出生缺陷，GSK面临了800例起诉并最终不得不支付了10亿美金的罚款。前车的惨痛教训历历在目，这次辉瑞会如果应对，我们拭目以待。
关于Zoloft
左洛复（英文商品名为Zoloft，盐酸舍曲林片）是由辉瑞公司研发的抗抑郁药，属于选择性五羟色胺再摄取抑制剂（SSRI），用于治疗抑郁症、强迫症及6岁以上儿童的强迫症，被多个国内外指南推荐为治疗抑郁症及强迫症的一线用药。左洛复用于治疗抑郁症的相关症状，包括伴随焦虑、有或无躁狂史的抑郁症。疗效满意后，继续服用可有效地防止抑郁症的复发和再发。左洛复治疗强迫症疗效满意后，继续服用可有效地防止强迫症初始症状的复发。
研发历程
1991年，Zoloft获得美国药品食品监督部门（FDA）的批准上市，治疗抑郁症，为抗抑郁领域带来新的选择。此后，Zoloft在美国又先后获得了强迫症、儿童强迫症、惊恐障碍、社交焦虑障碍等其他适应症。
1998年，Zoloft获得中国食品药品监督局（CFDA）的批准，在中国上市，名为左洛复，用于治疗抑郁症的相关症状，包括伴焦虑、有或无躁狂史的抑郁症。
2002年，JAMA杂志发表了舍曲林（左洛复）治疗抑郁伴急性心梗或不稳定心绞痛患者的研究（SADHART），这是第一篇以心脏安全性为主要终点的高质量研究。研究结果显示：舍曲林（左洛复）能够安全有效治疗伴有急性心梗或不稳定心绞痛的抑郁症患者。
2009年，Lancet杂志发表了12种新一代抗抑郁药的有效性和可接受性比较研究，该研究属于多治疗荟萃分析，共纳入117项随机对照研究。结果显示，综合考虑疗效，可接受性和购药成本的平衡，舍曲林可能是成人中重度抑郁初始治疗的最佳选择。作者建议将舍曲林作为抗抑郁药临床试验的金标准，以增加研究结果的实用性。
Pfizer Inc. (NYSE：PFE)Faces a Lawsuit Over Its Antidepressant Zoloft
Things are not looking great at the end Pfizer Inc. (NYSE：PFE) as the company is facing a trial over its antidepressant drug， Zoloft. The trial has earned Pfizer Inc. (NYSE：PFE)some bad reputation due to excessive press attention. It is being contended in the lawsuit that Pfizer Inc. (NYSE：PFE)knew that Zoloft causes heart defects in babies of mothers who had taken the medicine during their pregnancy. This trend was clearly visible in the first trial of the medicine by the company and since then a 1000 lawsuits have been filed against Pfizer Inc. (NYSE：PFE).
The evidence shows， that over the course of last year， the others who took the drug during pregnancy， gave birth to babies that had congenital anomalies. Several families are now filing a lawsuit against Pfizer Inc. (NYSE：PFE)， claiming that the risk associated with the medication was not revealed to them. It is pressed down on Pfizer Inc. (NYSE：PFE)that this side effect was not revealed by themdue to the fear of losing out on its sales and it kept on marketing the drug despite knowing the harm it may cause.
According to the lawyer Joe Zonies， who was representing a client whose baby had a heart defect， said that Pfizer Inc. (NYSE：PFE)deliberately withheld the information regarding the risk of the drug not only from the patients but also from the doctors.It is not hard to understand why Pfizer Inc. (NYSE：PFE) withheld such information. Back in 2005 Pfizer Inc. (NYSE：PFE)made a revenue of $2.6 billion from the sales of Zoloft and the drug was categorised as one of the most popular drug in the market.
Later in 2006 when Pfizer Inc. (NYSE：PFE)lost its exclusivity right， new generic forms of drug were developed but despite the introduction of the generic version of the drug， Zoloft remained quite popular. Last year Pfizer Inc. (NYSE：PFE)generated a total of $433 million from the sales of Zoloft. On the contrary， Pfizer Inc. (NYSE：PFE)’s lawyers have pushed hard that the company had taken all the necessary steps to avoid the side effects of the drug.
The defendants also claimed that appropriate tests were conducted before the drug was launched in the market and until the launch and in the clinical trials the drug displayed no signs of birth defects. Also there was no scientific data that could prove that Zoloft caused birth defects. The situation at the end is not a new one. In 2010， GlaxoSmithKline (NYSE：GSK) faced similar charges against their antidepressant drug Paxil.
The contentions against Paxil were the same i.e. they caused birth defects in babies of mother who took the medication during pregnancy. The company had to pay a fine of $1 billion for the settlement of 800 suits that were filed against it.