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All Stressed Out
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Bad Neighbors
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Treatment Snapshot
March 24, 2010
Excerpt from "Only 10 Seconds to Care"
December 23, 2009 – Wendy Harpham, MD
Cancer as a Turning Point
December 23, 2009 – Don Vaughan
Best Face Forward
December 23, 2009 – Lacey Meyer
Recipes from Chef Hans Rueffert
December 20, 2009
A Skinny Chef You Can Trust
December 22, 2009 – Karen Patterson
Getting Help
December 23, 2009 – Jo Cavallo
Stress Reducers
December 23, 2009 – Laurie M. Fisher
Cisforcupid.com
December 23, 2009 – Lacey Meyer
Only 10 Seconds to Care: Help and Hope for Busy Clinicians
December 23, 2009 – Kathy LaTour
Flavored-Cigarette Ban Takes Effect, With More to Come
December 23, 2009 – Lacey Meyer
Stress, Depression & PTSD
December 23, 2009 – Laurie M. Fisher
Imaging Strategies: The Bigger Picture
December 23, 2009 – Laura Beil
Herceptin Combinations Improve Survival, Lessen Heart Toxicity
December 23, 2009 – Laura Beil
Integrative Techniques: A Sampler
December 23, 2009 – Marc Silver
Drug Therapies
December 23, 2009 – Elizabeth Whittington
Letters from Our Readers
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Treatment Updates
December 23, 2009 – Staff Reports
CDC picks up the tab for colon cancer screening
December 23, 2009 – Lacey Meyer
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December 23, 2009 – Kathy LaTour
The More You Know
December 23, 2009 – Helen Osborne
Patients' Songs Take Flight
December 23, 2009 – Bunmi Ishola
Currently Viewing
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The 'Price' is $1 Million
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Pancreatic Cancer Symposia
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Tired of Being Tired?
December 23, 2009 – Lacey Meyer
Message From the Editor
December 23, 2009 – Debu Tripathy, MD
Beneficial Brew
December 23, 2009 – Lena Huang
Gut Reaction
December 23, 2009 – Karen Patterson
Today's Lesson: Cancer
December 23, 2009 – Bunmi Ishola
Uncertain Obligations
December 23, 2009 – Jo Cavallo
Beyond Face Value
December 22, 2009 – Terry Healey
Cancer's Silver Lining
December 22, 2009 – Don Vaughan
Kids Allowed
December 21, 2009 – Marc Silver
Layman's Terms
December 23, 2009 – Charlotte Huff
All Stressed Out
December 23, 2009 – Laurie M. Fisher
Bad Neighbors
December 22, 2009 – Laura Beil

Q&A: Cervical Cancer Vaccine

Is the Gardasil vaccine safe?

BY Len Lichtenfeld, MD
PUBLISHED December 23, 2009

Q: Is the Gardasil vaccine safe?

A: Gardasil, a vaccine to prevent cervical cancer, has been widely used in the United States since its approval by the Food and Drug Administration in June 2006. The vaccine works by targeting the cancer-causing strains of the human papillomavirus, or HPV, that cause the majority of cervical cancers.

As with any new medicine or vaccine released for public use, there are always concerns about whether it will be safe when used as directed in the general population. An article published in the Journal of the American Medical Association in August reviewed the side effects that have been reported to a central database since the vaccine’s release.  

The good news is that there were no real surprises in terms of side effects from Gardasil. The reactions were what would be expected from the information collected during the clinical trials that led to the vaccine’s approval.

More than 23 million doses of Gardasil were distributed in the U.S. from June 2006 through December 2008 (Gardasil is a three-dose vaccine). Of the more than 12,000 reported adverse events, fainting was the most common, and occurred 8.2 times for every 100,000 doses of the vaccine given to patients. Fainting is not uncommon after vaccination, according to the report, especially in young women ages 11 to 18. Realizing that someone could faint should alert parents and medical professionals to take precautions, such as keeping the patient in the doctor’s office for 15 minutes after the vaccine is given.

Other commonly reported side effects included reactions at the site of vaccination, dizziness, nausea, headache, hypersensitivity reactions, and urticaria (hives). About 6 percent were considered serious, including blood clots, autoimmune disorders, a form of paralysis called Guillain-Barré syndrome, and 32 deaths. Unfortunately, the researchers were not able to look at all the medical information of these patients, so we don’t know for certain whether the reactions were related to the vaccine or just coincidental.

It is always important to weigh the risks and benefits of any vaccine. For now, it appears Gardasil is reasonably safe and effective, but further monitoring of side effects is ongoing.

The American Cancer Society continues to recommend Gardasil for girls ages 11 and 12, and as young as 9 years old. Girls between 13 and 18 also should be vaccinated. Although the vaccine is approved for women ages 19 through 26, the Society does not believe there is sufficient evidence to show benefit in this age group because of the risk of previous HPV exposure. These women should talk with their health care professionals to determine whether or not they would benefit from vaccination.

The ACS is currently reviewing data on the HPV vaccine Cervarix, which the FDA approved in October (see “Second HPV Vaccine Approved, Plus Gardasil for Boys”).

—Len Lichtenfeld, MD, is deputy chief medical officer for the American Cancer Society 

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