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Gardasil Approved to Prevent Vulvar and Vaginal Cancers
The human papillomavirus vaccine Gardasil has been approved for two additional uses — prevention of vaginal and vulvar cancers caused by HPV types 16 and 18 — the FDA announced on Friday.
The label expansion was based on follow-up of more than 15,000 female subjects who participated in placebo-controlled trials of the vaccine. Among subjects who tested negative for HPV-16 and -18 at study entry, precancerous vulvar or vaginal lesions (all related to the two HPV strains) developed in 19 placebo recipients — and none of the Gardasil recipients.
The vaccine was not effective in women who had previously been infected with either HPV strain.
LINK(S):
FDA news release (Free)
Gardasil prescribing information (Free PDF)
Published in Physician's First Watch September 15, 2008
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