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Gardasil: Safety concerns persist, but may be unfounded

Last reviewed: December 2009

Should you expose your young daughter to potential risks from a vaccine that protects against cervical cancer--a disease that she may get 20 to 40 years from now? That's the question millions of parents face as television ads push for girls to receive Gardasil, a vaccine that prevents infection from four types of human papilloma virus (HPV)—the most common sexually transmitted virus in the U.S. Those four types cause most cases of cervical cancer and genital warts.

The Food and Drug Administration (FDA) approved Gardasil in 2006 for girls and young women to prevent cervical cancer and genital warts caused by the HPV types in the vaccine. But recently, complaints have emerged about the marketing and cost of Gardasil, and some parents have raised concerns about its safety. A new report by the FDA and the Centers for Disease Control and Prevention (CDC) found that serious complications had occurred, although most side effects appear to be consistent with those of other vaccines. "Safety monitoring hasn't revealed any major problems to date," says Lauri Markowitz, M.D., a medical epidemiologist at the CDC. "We think the benefits of the vaccine outweigh the risks."

To help you weigh the risks and benefits of Gardasil, we review the evidence.

This drug safety alert is made possible through a partnership between Consumer Reports Best Buy Drugs and the Research on Adverse Drug Events and Reports (RADAR) group, a pharmacovigilance group led by Charles Bennett, M.D. Ph.D. M.P.P.

These materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multi-state settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

If you think you have experienced an adverse event with this drug or any drug, especially if it is of a serious nature, it is important to 1) tell your doctor immediately and 2) report the event to the Food and Drug Administration via the FDA’s MedWatch Web site at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm or by calling 1-800-FDA-1088.

 
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