FDA Orders Amgen to Pull TV Ad for Psoriasis Drug

The Food and Drug Administration demanded Friday that Amgen Inc. pull television ads that the agency said made misleading claims about the company’s psoriasis drug, Enbrel.

The FDA said Amgen needed to take corrective measures to ensure that people who saw the ads got the truth.

The TV spots depicted exuberant adults with perfectly clear skin running along a beach and splashing in a pool. The agency said the ads left the overwhelming impression that Enbrel completely clears up psoriasis, when in fact, the injectable drug does not.

In addition, the FDA said, the ad trivializes the health risks associated with the drug, including potentially severe infections and malignancies.

The agency noted Enbrel carried strong warnings in its label, including one about the risk of tuberculosis. Patients who use it have triple the expected risk of lymphoma, a blood cancer, and it is not clear whether the drug is responsible, the FDA said.

“The TV ad overstates the effectiveness of Enbrel, fails to communicate the limitations of the indication, thereby broadening the indication, and it minimizes the risks associated with the drug,” the FDA said in an official warning letter to Amgen.

A spokeswoman for Thousand Oaks-based Amgen said the ad had been withdrawn and it was reviewing the FDA letter.

The agency told Amgen that it must not only discontinue the ads, but submit a “comprehensive plan of action to disseminate truthful, non-misleading and complete corrective messages” to the audience that saw the ads.

Enbrel is a biotechnology drug used to treat inflammation associated with psoriasis, which causes the skin to break out in red, scaly patches, and rheumatoid arthritis, a joint disease.

Amgen, which markets Enbrel along with Wyeth, said Enbrel had been taken by 280,000 people. It had sales of $1.9 billion in 2004.

Amgen’s shares fell 35 cents to $62 on Nasdaq.