Dusa Pharmaceuticals Inc. exaggerated in an advertisement how well its treatment for actinic keratosis worked, U.S. regulators said.
The ad for the topical solution Levulan Kerastick ``raises significant public health and safety concerns'' because it says the product is safer and works better than has been shown in studies or clinical experience, according to a warning letter posted today on the Food and Drug Administration's Web site. Dusa agreed to stop distributing the ad at the FDA's request.
The company was surprised by the FDA's action because the language in question has been used in promotional materials since Levulan Kerastick was introduced in 2000, said Scott Lunahl, vice president of Wilmington, Massachusetts-based Dusa, in a telephone interview. Dusa will work with regulators to answer their concerns, he said.
The product is applied to the face or scalp to heal actinic keratosis, lesions usually caused by sun damage that can lead to cancer if untreated. Dusa's ad failed to identify any risks of the treatment and suggested that it may work within a week, while the prescribing information says improvement may take four weeks, the FDA said in its letter, dated April 20.
Shares of Dusa fell 15 cents, or 4.5 percent, to $3.20 at 3:59 p.m. New York Time in Nasdaq Stock Market composite trading.
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