Gardasil Approval Expanded to Include Anal Cancer

Among people aged 9 to 26

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WEDNESDAY, Dec. 22, 2010 (HealthDay News) -- U.S. Food and Drug Administration approval of Gardasil (human papillomavirus vaccine) has been widened to include prevention of anal cancer and associated precancerous lesions, the agency said Wednesday in a news release.

Human papillomavirus (HPV) is associated with about 90 percent of the estimated 5,300 cases of anal cancer diagnosed in the United States each year, the FDA said, citing statistics from the American Cancer Society. More women are diagnosed than men.

The latest approval for Gardasil covers people aged 9 to 26. The vaccine was previously approved for the same age group to prevent cervical, vulvar and vaginal cancers in females, and for genital warts among both sexes.

Gardasil won't prevent development of anal precancerous lesions already present at the time of vaccination, the FDA said.

The most common adverse reactions to the vaccine include fainting, injection-site pain, headache, nausea and fever.

More information

To learn more about anal cancer, visit the U.S. National Cancer Institute.


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