FDA warns Amgen over video promoting cancer drug Vectibix without disclosing its risks

Washington — The U.S. Food and Drug Administration (FDA) warned drugmaker Amgen over a promotional video for Vectibix, a medicine for adults with a type of advanced colorectal cancer, that the agency says presented a misleading picture of the product.

In a letter dated August 12, the FDA said the video presented Vectibix as an option for those patients and noted that infusions can take 60 minutes or less and do not require premedication, but included no information about its risks, even though the drug carries a boxed warning for severe skin reactions.

According to the agency, the drug can also cause potentially fatal infusion reactions, lung disease, kidney failure and other serious side effects. In addition, the video failed to clarify which patients can use it, including limits tied to tumor testing, which in the FDA’s view creates “a misleading impression about the drug’s FDA-approved indication.”

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 audience that saw the video. The agency warned that if the company does not address the issue, it could face legal action, including product seizure or an injunction.

The case is a reminder for patients that drug advertising does not replace a conversation with a doctor: the exact indication, the prior tests required and the risks should be reviewed with the treating physician before starting or changing a cancer treatment.

Photo: Archivo A Lo Claro

Source: Reuters