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Controversial Drug Gardasil Approved to Prevent Anal Cancer

Posted on December 30, 2010

The drug Gardasil has been controversial ever since its approval by the U.S. Food and Drug Administration (FDA) in 2006 for the prevention of genital warts and cervical and vaginal cancer, but on Wednesday, December 33, an FDA press release announced the approval of the vaccine for the prevention of anal cancer due to the human papillomavirus (HPV) virus types 6, 11, 16, and 18 in people ages 9 through 26 years.

The HPV virus is associated with about 90 percent of anal cancers. It’;s estimated about 5,300 people are diagnosed every year in the U.S., with the number of women diagnosed outnumbering men.

Since its approval, more than 65 million doses of Gardasil have been distributed to young women. Manufacturer Merck and Co. has been criticized for aggressively marketing Gardasil through the “One Less” campaign, which targeted adolescent and teenage girls, and Merck lobbied female legislators unsuccessfully to introduce state laws to make the cervical cancer vaccine mandatory.

In January 2009, Merck was denied expanded approval for Gardasil by the FDA, who required more data on whether the drug would be effective if used by women who were already sexually active at ages 27 to 45. It is currently only approved for use in young women ages 9 to 26.

Additionally, the nonprofit group Judicial Watch has made public the FDA’;s internal reports showing at least 10 deaths related to use of the drug since September 2007 among young users after being vaccinated, along with more than 140 serious adverse events.

If you or a loved one has suffered an adverse side effect because of using Gardasil or another dangerous drug, an experienced Florida pharmaceutical litigation attorney will want to hear the specifics of your injury to help build a strong case on your behalf.