Gardasil clarifies label warning

The maker of the cervical cancer vaccine known as Gardasil was ordered by the Food and Drug Administration last month to issue stronger warnings on its label concerning fainting to prevent head injury.

According to the Center for Disease Control’s Web site, Gardasil has had more than 24 million does distributed in the U.S. since its approval in June 2006. News reports and watchdog groups raised questions about the safety of the vaccine, including reports of paralysis, miscarriages and death in the past two years. While worries about the vaccine’s side effects continue, officials at Watkins Memorial Health Center see no danger in the vaccine and continue to offer Gardasil to students.

Patricia Denning, chief of staff at Watkins, said the controversy surrounding the vaccine was all coming from outside the medical community.

“In the medical world, there is no controversy,” Denning said.

The vaccine, produced by the pharmaceutical company Merck & Co.,Inc., is designed to protect women against the human papillomavirus, known as HPV, which is a leading cause of cervical cancer.

Studies conducted by the Vaccine Adverse Event Reporting System show 13,758 reports of “adverse side effects,” with 93 percent of those reports considered to be non-serious. According to the CDC Web site, the non-serious side effects include headache, nausea and fever, while serious side effects include blood clots, Guillain-Barré Syndrome, a rare disorder that can cause paralysis, and possible death.

The VAERS report listed 39 deaths related to Gardasil as of May 1.

Mai Hester, coordinator at Watkins, said that with any type of vaccine there were going to be side effects. Hester said the HPV vaccine was actually safer than the flu vaccine because it did not involve using a live strain of the disease.

April Rand, Missouri Valley, Iowa, graduate student, said she started receiving the vaccine in 2007 at Watkins. The vaccine requires three separate shots spaced months apart. She said she found out about Gardasil from the news coverage it had received. She finished the treatment in February 2008.

Rand, 23, said her concern was taking the vaccine before it was too late for her because the vaccine is only available for those age 9-26. For Rand, this concern outweighed the possibility of side effects and her fear of needles.

Rand said she thought the vaccine was incredibly important because it protected against the most common strand of HPV that causes cervical cancer.

“I don’t think many people know how common HPV is these days,” Rand said.

Hester said the University was one of the original testing sites for Gardasil in 1999. She said Henry Buck, former gynecologist at Watkins and member of the American College Health Association, was able to persuade the ACHA’s task force to select the University as a site for testing.

Denning said Merck & Co., Inc. was currently doing research to test a vaccine that works for men and to extend the age limit for the women’s vaccine. She said that because HPV was passed to both partners, it wouldn’t make sense to vaccinate only half of the partnership to stop it from spreading.

“Treat one partner but not the other, it comes right back,” Denning said.

Hester said Watkins informed students about the vaccine during new student orientation. She said that during these first few years since the drug’s approval, she had seen a steady stream of students coming in for the vaccine.

Amanda Horner, 2008 alumnus, said that she wasn’t interested in taking Gardasil because of the cost and that she felt safe with her boyfriend. Horner said that because she knew her boyfriend of six years didn’t have HPV, she didn’t feel the need to get the vaccine.

— — Edited by Mike Bontrager

 

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