FDA says ad for Abbott's Humira downplays risks

WASHINGTON Tue Dec 23, 2008 5:34pm EST

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WASHINGTON (Reuters) - An advertisement for Abbott Laboratories' Humira minimizes the arthritis drug's risks while suggesting it can treat a wider range of patients than it is approved to treat, the U.S. Food and Drug Administration said in a letter released on Tuesday.

The drug is cleared to treat certain patients with arthritis, psoriasis, Crohn's Disease or a form of arthritis called ankylosing spondylitis.

But the ad, used in a trade publication for doctors, "is misleading because it suggests that Humira is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience," the FDA wrote in the December 16 letter to the drugmaker.

Abbott spokeswoman Michelle Johnson said the ad targeted doctors in the American Academy of Dermatology's trade publication Derm News earlier this year and is no longer in use.

"We are working to address the agency's concerns," she told Reuters.

In the case of psoriasis, the drug is only approved for patients when other therapies fail, the FDA said. The ad "misleadingly suggests that Humira is approved for any patient with moderate to severe chronic plaque psoriasis," it said.

Humira use is also linked to tuberculosis and other infections and includes a strong warning on its label.

In the ad, Abbott included the risk "in extremely small font size, and in single-spaced paragraph format that makes the information extremely difficult to read" while promoting its benefits with pictures and large text, the FDA said.

The FDA, which stopped short of issuing a formal warning to the company, requested a reply from the drugmaker by January 2.

The FDA letter is on the agency's website here

(Reporting by Susan Heavey; Editing by Bernard Orr)

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