FDAnews Drug Daily Bulletin

WYETH PAMPHLET PROMPTS FDA WARNING LETTER

June 14, 2006
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The FDA has issued a warning letter to Wyeth Pharmaceuticals, citing a "false or misleading" consumer brochure for its ReFacto Antihemophilic Factor (Recombinant), used in patients with hemophilia A.

The FDA has found that the brochure, titled "Bob's World," which the company submitted for approval last Oct. 18, "makes unsubstantiated safety claims that ReFacto is safer than has been demonstrated by substantial evidence or substantial clinical experience" and therefore potentially encourages unsafe use of the drug. The letter was sent April 13 and made public on the FDA's website June 2.

The text of the warning letter is available at http://www.fda.gov/cber/adpromo/ahfwye041306.htm (http://www.fda.gov/cber/adpromo/ahfwye041306.htm).