Pictured: Sanofi's building in Germany, taken at night/iStock, Panama7

图为：赛诺菲在德国的建筑，摄于夜间/巴拿马伊斯托克7

Sanofi has reached a settlement agreement for around 4,000 lawsuits regarding claims that its discontinued heartburn drug Zantac (ranitidine) caused cancer, according to several media reports Wednesday.

据周三多家媒体报道，赛诺菲已就约4000起诉讼达成和解协议，这些诉讼涉及其停药的胃灼热药Zantac（雷尼替丁）导致癌症的指控。

The French pharma did not disclose the terms of the deal, including the specific settlement amount, but revealed that it would resolve most of the Zantac-related lawsuits across all U.S. state courts outside of Delaware, where most of the cases are still pending, according to reporting by Reuters.

据路透社报道，这家法国制药公司没有透露交易条款，包括具体的和解金额，但透露将解决特拉华州以外所有美国州法院的大多数与Zantac相关的诉讼，大多数案件仍在审理中。

While Sanofi is still in the process of finalizing the deals, the company insists that it has no liability in the matter and is only settling to stem other expenses and distractions associated with the case. “Sanofi has vigorously defended the Zantac litigation since the outset and will continue to do so,” a company spokesperson told Reuters in a statement..

虽然赛诺菲仍在敲定交易，但该公司坚称，它对此事不承担任何责任，只是解决了与此案相关的其他费用和分心问题。赛诺菲公司发言人在一份声明中告诉路透社：“赛诺菲从一开始就为Zantac的诉讼进行了有力的辩护，并将继续这样做。”。。

More than 70,000 Zantac cases—against Sanofi and other drugmakers—still hang in the balance and are being reviewed in the Delaware Superior Court, according to Reuters.

据路透社报道，针对赛诺菲和其他制药商的7万多起Zantac案件仍悬而未决，特拉华州高等法院正在对其进行审查。

Zantac is a histamine 2-receptor antagonist that works by lowering the secretion of gastric acid, the main driver of heartburn. Originally developed by Glaxo Holdings, which now forms part of GSK, the drug was first approved in 1983 and became the world’s top-selling drug five years later, according to a 2019 analysis by Reuters..

Zantac是一种组胺2受体拮抗剂，其作用是降低胃酸的分泌，胃酸是胃灼热的主要驱动因素。根据路透社2019年的分析，该药最初由葛兰素史克控股公司开发，现已成为葛兰素史克的一部分，1983年首次获得批准，五年后成为世界上最畅销的药物。。

Later, competitors would develop generic alternatives to Zantac, hoping to share in its sales. Eventually, through a series of deals and transactions, Zantac would come to be owned by Sanofi.

后来，竞争对手将开发Zantac的通用替代品，希望分享其销售。最终，通过一系列交易，Zantac将归赛诺菲所有。

In 2019, the FDA alerted healthcare professionals and patients to potential NDMA contamination found in several samples of ranitidine, the active ingredient in Zantac and its iterated versions.

2019年，FDA提醒医疗保健专业人员和患者注意在雷尼替丁的几个样品中发现的潜在NDMA污染，雷尼替丁是Zantac及其迭代版本的活性成分。

NDMA is an environmental contaminant typically found in water and foods, including dairy products, meat and vegetables. The FDA classifies NDMA as a probable human carcinogen, indicating that it “could” cause cancer.

NDMA是一种环境污染物，通常存在于水和食品中，包括乳制品，肉类和蔬菜。FDA将NDMA归类为可能的人类致癌物，表明它“可能”致癌。

At the time of the FDA’s alert, the regulator played the risks down noting that patients could “trust that their medicines are safe” and that the NDMA levels present in ranitidine “barely exceed amounts you might expect to find in common foods.”

在FDA发出警报时，监管机构淡化了风险，指出患者可以“相信他们的药物是安全的”，雷尼替丁中的NDMA水平“几乎不超过常见食物中的NDMA水平”

However, in April 2020, the FDA called on ranitidine manufacturers to pull their products—both prescription and over-the-counter formulations—from the market. The regulator found that the concentrations of the NDMA impurities could increase over time in some products, especially when stored at higher temperatures, and this could lead to consumers being exposed to unacceptable levels of NDMA..

然而，在2020年4月，FDA呼吁雷尼替丁制造商将其处方药和非处方药从市场上撤出。监管机构发现，某些产品中NDMA杂质的浓度可能会随着时间的推移而增加，尤其是在较高温度下储存时，这可能导致消费者暴露于不可接受的NDMA水平。。

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

特里斯坦·马纳拉克（TristanManalac）是一位独立的科学作家，总部位于菲律宾马尼拉。在LinkedIn上联系他，或发电子邮件给他tristan@tristanmanalac.com或tristan.manalac@biospace.com.