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FDA: GSK makes misleading claims on Web site, other materials

Pharma Compliance Alert, July 5, 2006

GlaxoSmithKline makes promotional claims about its treatment for initial genital herpes that directly contradict the patient information, according to an FDA warning letter.

The FDA cited a portion of GlaxoSmithKline's Web site for Zovirax ointment that suggests that the treatment can reduce transmission of genital herpes to others. Not only does the FDA say that this claim contradicts the PI, but that it's concerning from a public health perspective. Although a statement at the bottom of the Web page says that the drug doesn't prevent transmission, the FDA says it "does not correct the misleading suggestion conveyed by the web page as a whole."

Also referenced in the warning letter is a section of the Web site covering clinical trials that suggests that Zovirax is appropriate for the treatment of recurrent episodes of genital herpes.

Another consumer-directed promotional tool, an STD Awareness Deck Card, omits the specific indication for the drug and fails to include any risk information for Zovirax, says the letter.

Read the entire letter here.

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