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FDA warns Amgen over cancer drug promotional video

By Reuters News

Oct 27 (Reuters) - The US FDA on Tuesday warned Amgen AMGN.O that a promotional video for its colorectal cancer drug was misleading because it highlighted the benefits while failing to adequately disclose serious safety risks and patient limitations.

Here are some details:

  • In a warning letter dated August 12, the FDA said the video promoted the drug 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

  • The regulator said that the video contained no information on risk, despite Vectibix carrying a boxed warning for severe skin reactions

  • The drug can also cause potentially fatal infusion reactions, lung disease, kidney failure and other serious side effects, the FDA said

  • The regulator said the video failed to disclose which type of patients can use Vectibix, including limits tied to tumor testing

  • "By failing to adequately communicate the full indication for Vectibix and limitations of use associated with Vectibix, the video creates a misleading impression about the drug's FDA-approved indication and use," the FDA said

  • The regulator told Amgen to stop using misleading promotional material, submit a written response within 15 working days and propose corrective communications for the video's audience

  • It said failure to address the issues could lead to legal action, including product seizure or an injunction

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