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Santen issued warning letter for Quixin advertising
ROCKVILLE, Md. — U.S. regulators have issued a warning letter to Santen, objecting to “dissemination of false or misleading promotional materials for Quixin,” the company’s anti-infective medication.
After reviewing a promotional flashcard for Quixin (levofloxacin ophthalmic solution 0.5%), the Division of Drug Marketing, Advertising and Communications concluded “that it is false or misleading” and in violation of the Federal Food, Drug and Cosmetic Act.
Specifically, the flashcard is in violation of the act because “it suggests that the drug is safe and effective for an unapproved new use; i.e., prophylactic, preoperative use in intraocular surgery to prevent infections inside the eye.”
The warning letter calls the claim “particularly troublesome” because Quixin has been proven safe and effective in trials for the treatment of bacterial conjunctivitis, an external infection. “FDA is not aware of any substantial evidence or substantial clinical experience that would support Santen’s claim that Quixin is safe and effective to prevent internal infections of the eye due to invasive ocular surgery.”