FDA
Approves New Indication for Gardasil to
Prevent Genital Warts in Men and Boys
October
16, 2009 -- The U.S. Food and Drug Administration
today approved use of the vaccine Gardasil for the
prevention of genital warts (condyloma acuminata)
due to human papillomavirus (HPV) types 6 and 11
in boys and men, ages 9 through 26.
Each year, about 2 out of every 1,000 men in the
United States are newly diagnosed with genital warts.
Gardasil
currently is approved for use in girls and women ages
9 through 26 for the prevention of cervical, vulvar
and vaginal cancer caused by HPV types 16 and 18;
precancerous lesions caused by types 6, 11, 16, and
18; and genital warts caused by types 6 and 11.
HPV
is the most common sexually transmitted infection
in the United States and most genital warts are caused
by HPV infection.
"This
vaccine is the first preventive therapy against genital
warts in boys and men ages 9 through 26, and, as a
result, fewer men will need to undergo treatment for
genital warts," said Karen Midthun, MD, acting
director of the FDA's Center for Biologics Evaluation
and Research.
Gardasil's
effectiveness was studied in a randomized trial of
4,055 males ages 16 through 26 years old. The results
showed that in men who were not infected by HPV types
6 and 11 at the start of the study, Gardasil was nearly
90 percent effective in preventing genital warts caused
by infection with HPV types 6 and 11.
Studies
were conducted to measure the immune response to the
vaccine in boys ages 9 through 15. The results showed
that the immune response was as good as that found
in the 16 through 26 years age group, indicating that
the vaccine should have similar effectiveness.
The
manufacturer will conduct post-marketing studies to
obtain additional information on the safety and effectiveness
of Gardasil in boys and men.
Gardasil
is given as three injections over a 6-month period.
Headache, fever and pain at the injection site, itching,
redness, swelling and bruising, were the most common
side effects observed.
Gardasil
is manufactured by Merck and Company Inc. of Whitehouse
Station, NJ.
Gardasil
Product Information
Consumer
Inquiries: 1-888-INFO-FDA
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