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.
Source: GSM · USA (original Chinese edition)
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