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IRVINE, Calif., Jun 25, 2003 (United Press International via COMTEX) -- For a second time, the Food and Drug Administration has warned Irvine, Calif.-based, Allergan Inc. that ads for its anti-wrinkle drug Botox are misleading.
The FDA said Allergan's ads falsely identify the prescription drug as a cosmetic treatment, fail to reveal details about which wrinkle types it treats, and minimize the drug's risks.
The agency sent a similar warning letter to Allergan in September.
In its latest letter, posted on the agency's web site, the FDA instructed the company to immediately withdraw all print ads and other promotional activities that contain the misleading claims and to respond in writing within 10 days.
FDA spokeswoman Lenore Gelb called the warning letter a "very serious event," and said the agency was "concerned that by continuing to promote Botox in a false and misleading manner, these materials are raising significant public health concerns."
Copyright 2003 by United Press International.
