食品药品监管局警告Amgen：结直肠癌药Vectibix宣传视频只讲疗效、隐瞒严重风险
据路透社10月27日报道，美国食品药品监管局（FDA）已向制药企业Amgen发出警告信，指其结直肠癌药物Vectibix（通用名panitumumab，帕尼单抗）的一支宣传视频具有误导性：视频只强调疗效，却完全没有披露该药的严重安全风险和适用人群限制。警告信由FDA药品评价与研究中心下属的处方药推广办公室（OPDP）于8月12日发出，近日对外公开。
FDA在信中称，这支视频把Vectibix宣传为成人某种晚期结直肠癌的治疗选择，并提到该药输注时间可在60分钟以内、无需预先用药，但视频中没有任何风险信息。而Vectibix带有黑框警告，提示严重皮肤反应风险；该药还可能引发可致命的输注反应、肺部疾病、肾衰竭等严重副作用。
FDA还指出，视频没有充分说明该药获批的适应症和使用限制，包括与肿瘤基因检测状态相关的限制。FDA表示，由于未能充分告知Vectibix完整的获批适应症和使用限制，该视频对药物的获批适应症和用法造成了误导性印象。
FDA要求Amgen停用误导性宣传材料，在15个工作日内提交书面回复，并提出面向该视频受众的纠正传播方案。FDA表示，若相关问题得不到处理，可能面临产品查扣或禁令等法律行动。Amgen是总部位于加利福尼亚州Thousand Oaks的生物制药上市公司，Vectibix是其肿瘤药物产品线中的一款靶向药物。
FDA Warns Amgen That Vectibix Promotional Video Misled Patients by Omitting Serious Risks
The U.S. Food and Drug Administration (FDA) has warned pharmaceutical company Amgen that a promotional video for its colorectal cancer drug Vectibix (panitumumab) was misleading because it highlighted the drug's benefits while failing to adequately disclose serious safety risks and patient limitations, Reuters reported on October 27. The warning letter, dated August 12, was issued by the Office of Prescription Drug Promotion (OPDP) within the FDA's Center for Drug Evaluation and Research and was recently made public.
According to the FDA, the video promoted Vectibix as an option for adults with a type of advanced colorectal cancer and noted that infusions can take 60 minutes or less and do not require premedication, yet the video contained no information on risk. Vectibix carries a boxed warning for severe skin reactions, and the drug can also cause potentially fatal infusion reactions, lung disease, kidney failure, and other serious side effects, the FDA said.
The FDA also said the video failed to adequately communicate the drug's approved indication and limitations of use, including limits tied to tumor testing. By failing to adequately communicate the full indication for Vectibix and the limitations of use associated with it, the video creates a misleading impression about the drug's FDA-approved indication and use, the agency said.
The FDA told Amgen to stop using the misleading promotional material, submit a written response within 15 working days, and propose corrective communications for the video's audience. Failure to address the issues could lead to legal action, including product seizure or an injunction, the agency said. Amgen is a publicly traded biopharmaceutical company headquartered in Thousand Oaks, California, and Vectibix is one of the targeted therapies in its oncology portfolio.
来源：GSM·美国（原文链接）
图片来源：Amgen公司标志（上市公司主体稿按规矩用企业logo）。来源：Wikimedia Commons，公共领域文字标志（PD textlogo）。
