FDA warns Amgen over Vectibix video omitting risk details

The FDA warned Amgen that a submitted promotional video for its colorectal cancer drug Vectibix was misleading because it touted benefits without disclosing serious risks, including severe skin reactions and potentially fatal infusion and lung complications. The agency also said the video failed to clearly explain the drug’s approved use and patient restrictions, including limitations tied to tumor testing, and directed Amgen to respond and address the violations; failure to do so could prompt legal action. Amgen said an incorrect video file was inadvertently submitted and never publicly distributed, while the version shown publicly included the required safety information; the company said it submitted the correct file to the FDA.