FDA warns Amgen over cancer drug promotional video

Amgen

Tue 18:25

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

 (Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shailesh Kuber)
 ((Padmanabhan.Ananthan@thomsonreuters.com;))