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FDA issues warning letter on Botox
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U.S. regulators have issued a warning letter to Allergan regarding its marketing of Botox Cosmetic (botulinum toxin type A).
The Food and Drug Administration alerted Allergan that some of its advertisements for Botox Cosmetic “fail to disclose that Botox Cosmetic is a biological drug … omit important limitations on the indicated use of the product and … minimize important risk information.”
The FDA specifically called three advertisements for the drug “false and/or misleading because they falsely identify your product as a cosmetic treatment, fail to reveal material facts about the product’s use, and minimize the risk information presented.”
In a letter addressed to Allergan and posted on the agency’s Web site, the FDA indicated it is “very concerned” that by promoting Botox Cosmetic in this way, the ad materials are “raising significant public health concerns.”
At issue for the FDA is the company’s minimization of patient risk. The letter points out that Allergan’s own clinical data indicates that 49.1% of patients undergoing treatment with Botox Cosmetic experienced some type of adverse reaction. The FDA noted that the addition of “…if any occur…” to the fair balance statement on adverse reactions in the ad minimizes the risk demonstrated in the clinical trials.
Allergan spokespersons said they intend to work with the FDA to rectify these issues.