Unreadable risk info was at issue in an FDA rebuke of an Abbott ad for Humira.
The FDA issued Abbott Laboratories an untitled letter, dated Dec. 16, saying a journal ad for Humira “broadens the approved indication and minimizes the risks” associated with use of the drug.
The agency said the ad, which appeared in the American Academy of Dermatology Post Meeting News, is misleading because it “suggests that Humira is approved for any patient with moderate to severe chronic plaque psoriasis,” when in fact, the drug is indicated only for “adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.”
The letter noted that the complete indication was included in the ad, but was buried at the bottom, in hard-to-read white text on a pink background, single spaced, along with risk information.
The ad, the agency concluded, “fails to convey this important risk information with a prominence and readability reasonably comparable to the claims of effectiveness in the ad.”
Humira carries a boxed warning noting that tuberculosis, invasive fungal infections and other opportunistic infections have been observed in Humira patients.