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善胃得的争议事件

以下收录公开来源中与该品牌相关的争议事件。列出一条并不表示过错已经证实。

返回词条共 7 条

  1. 2021

    弗吉尼亚州女性就 Zantac 提起癌症诉讼

    提起诉讼

    在2021年8月报道的一起诉讼中，Deborah Haskins 起诉 Zantac 的制造商，指称该药导致其食管癌，且制造商未向消费者警示风险。报道同时指出，研究尚未明确证明 Zantac 与癌症有关。该诉讼被呈现为原告的主张；报道未提及法院裁决或任何责任认定。

    来源摘录

    • In the lawsuit, Haskins also noted that if she had known about the unsafe levels of NDMA in Zantac, she never would have purchased the medication.
    • The lawsuit named Sanofi, Zantac's current manufacturer in the U.S. as a defendant. It also included previous makers, Boehringer Ingelheim Pharmaceuticals and GlaxoSmithKline.
    • While research has not explicitly linked Zantac to cancer, the esophagus is acted upon by the drug.
    来源

  2. 2020

    FDA下令将Zantac从商店下架

    禁令或限制

    2020年4月，美国食品药品监督管理局（FDA）下令立即将Zantac从商店下架。据报道，美国官员指出该药物存在致癌风险，并以此作为采取该行动的理由。该命令针对该产品在商店的销售，报道称下架立即生效。报道未进一步说明具体风险、召回范围或后续监管措施。

    来源摘录

    • U.S. officials say Zantac (Ranitidine) has shown to be a risk factor in causing cancer.
    • the Food and Drug Administration has just ordered the product to be pulled from stores effective immediately.
    来源

  3. 2019

    NDMA污染争议

    部分雷尼替丁样本中发现NDMA，导致召回、监管调查、市场撤市以及公众对Zantac和仿制雷尼替丁产品安全的广泛关注。

    来源

  4. 2019

    Zantac产品责任诉讼

    患者提起诉讼，声称雷尼替丁产品使他们接触NDMA并导致癌症或其他伤害。诉讼涉及多家制造商、分销商、零售商和品牌权持有人，在科学证据和因果关系方面存在重大争议。

    来源

  5. 2019

    GSK宣布在全球召回Zantac

    宣布召回

    葛兰素史克表示，作为预防措施，将在所有市场召回处方药Zantac；此前美国食品药品监督管理局在该药物中发现了不可接受水平的疑似致癌杂质。GSK还表示，将暂停所有剂型Zantac产品的放行、分销和供应。

    品牌回应

    • 召回 — GSK

      GlaxoSmithKline <GSK.L> on Tuesday said it is recalling the popular heartburn medicine Zantac in all markets as a "precaution"

    • 调查 — GSK

      GSK is continuing with investigations into the potential source of the NDMA

    来源摘录

    • GSK is continuing with investigations into the potential source of the NDMA (chemical),
    • Britain's medicines watchdog said GlaxoSmithKline (GSK) was recalling four prescription-only Zantac medicines: a syrup, an injection and tablets of 150 and 300 milligram (mg) dosages.
    • GlaxoSmithKline on Tuesday (Oct 8) said it was recalling the popular heartburn medicine Zantac in all markets as a "precaution", days after the United States Food and Drug Administration found "unacceptable" levels of probable cancer-causing impurity in the drug.
    来源

  6. 2019

    赛诺菲在美国和加拿大召回 Zantac

    宣布召回

    2019年10月，赛诺菲宣布在美国和加拿大自愿召回 Zantac。此次召回公布之际，公司和监管机构正在调查该药物中检测到的 NDMA。来源报道称，此次召回涉及这两个市场上的该款胃灼热药物，并将其与对检测到的 NDMA 的调查联系起来。

    品牌回应

    • 召回 — Sanofi

      Sanofi said Friday it will recall the widely-used heartburn drug Zantac from stores in the United States and Canada

    来源摘录

    • Sanofi said Friday it will recall the widely-used heartburn drug Zantac from stores in the United States and Canada as the drugmaker and Food and Drug Administration investigate a probable carcinogen detected in the drug.
    • The FDA last month said it discovered a probable carcinogen called NDMA, or nitrosodimethylamine, in the drug Zantac and its generic versions.
    来源

  7. 2019

    CVS暂停销售Zantac及雷尼替丁产品

    整改

    CVS Pharmacy表示，已暂停销售Zantac品牌和CVS Health品牌的雷尼替丁产品，直至另行通知。此次暂停销售是在FDA警告雷尼替丁产品可能含有潜在人类致癌物之后作出的。据来源报道，这些产品当时并未被召回，FDA也未建议患者停止服用。

    CVS Pharmacy表示，在FDA警告雷尼替丁产品可能含有潜在人类致癌物后，暂停销售Zantac品牌和CVS Health品牌的雷尼替丁产品，暂停时间另行通知。报道指出，这些产品当时并未被召回，FDA也未建议患者停止服用。

    来源摘录

    • CVS Pharmacy announced Saturday that it has suspended the sale of all Zantac brand and CVS Health-brand ranitidine products until further notice
    • The announcement comes in response to an alert from the FDA that ranitidine products may contain a possible human carcinogen and cause cancer.
    • While Zantac and ranitidine products have not been recalled, and the FDA is not recommending patients stop taking these products, customers can still return the products to CVS for a refund.
    来源