FDA: Gardasil not effective in women 27 or older

Consumer Reports News: April 08, 2011 10:53 AM

The U.S. Food and Drug Administration has rejected an application from the maker of Gardasil, a vaccine against the human papillomavirus (HPV), to expand its use to women 27 and older. In fact, the agency said the company, Merck, should add a statement to the vaccine label saying that it’s not proven to prevent HPV-related complications in women over that age, including cervical cancer.

HPV is the most common sexually transmitted disease—at least half of women and men contract it at some point in their lives. Gardasil protects against the four strains of the virus that cause the most cases of cervical cancer and genital warts. It can also prevent cancers of the vulva and vagina in women, and anal cancer in both men and women. It was approved for girls and young women age 9 to 26 in 2006, and was expanded for use in boys and young men of the same age in 2009.

Bottom line: Our previous analysis of the research concluded that the vaccine is generally quite safe for those recommended age groups, though it’s worth discussing the risks and benefits of the vaccine with your doctor first, and understand the necessary precautions.

Importantly, note that even if you’ve been vaccinated you probably still need routine Pap smears. That’s because the vaccine does not prevent against all strains of HPV that can cause cervical cancer. Pap smears should be annual, unless their combined with a test for HPV, in which case they can be every two to three years if you have only one sexual partner. And women 65 and older with several consecutive normal Pap smears can usually stop getting them.

U.S. Prescribing Information for Gardasil Updated; Indication Not Granted for Use in Adult Women [Merck]

Kevin McCarthy

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