Pharmaceutical

FDA approves Gardasil for use in preventing anal cancer

The U.S. Food and Drug Administration (FDA) has approved the use of the Gardasil vaccine for the prevention of anal cancer. Previously, the drug was approved only for use in girls and young women, for the prevention of cervical cancer. Gardasil targets the human papillomavirus (HPV), a sexually transmitted virus that can cause cervical cancer. Recent studies have also show the virus can cause anal cancer.

The approval expands the audience for the Merck & Col. manufactured drug to include all people – boys and girls – ages 9 through 26. Gardasil protects against four kinds of HPV – 6, 11, 16 and 18 – that cause up to 90 percent of anal cancer cases. Recently, Gardasil’s use was expanded to include prevention of vulvar and vaginal cancer in girls and young women, and for the prevention of genital warts in both males and females.

While the Gardasil vaccine is “recommended” by the FDA for the prevention of cervical cancer, it does not yet have that same approval for universal vaccination for males. The risk of anal cancer is higher for homosexual men who engage in sex with other men.

Approved in 2006 for the prevention of cervical cancer only, the Gardasil vaccine has since been linked to serious adverse events, including blood clots, autoimmune disorders and more than 30 reports of death following the injections. The vaccine is given in a series of three injections over a six-month period.