Gardasil Linked to Nerve Disorder

<http://www.webmd.com/cancer/cervical-cancer/news/20090430/gardasil-linked-to-nerve-disorder?src=RSS_PUBLIC>http://www.webmd.com/cancer/cervical-cancer/news/20090430/gardasil-linked-to-nerve-disorder?src=RSS_PUBLIC
 


Cervical Cancer Vaccine May Raise Risk of Guillain-Barre Syndrome
By <http://www.webmd.com/charlene-laino>Charlene Laino
WebMD Health News
Reviewed by <http://www.webmd.com/louise-chang>Louise Chang, MD

April 30, 2009 (Seattle) -- Girls and women who receive the 
<http://www.webmd.com/drugs/drug-144456-gardasil+im.aspx>Gardasil 
vaccine to prevent 
<http://www.webmd.com/cancer/tc/cervical-cancer-topic-overview>cervical 
cancer may be at increased risk of a rare but serious disorder of the 
nervous system in the first few weeks after getting their shots, 
researchers report.

Overall, the vaccine does not raise the odds of developing 
Guillain-Barre syndrome (GBS), a disorder of the peripheral nervous 
system, says Nizar Souayah, MD, of the University of Medicine and 
Dentistry of New Jersey in Newark.

"But there is clear evidence from our database of an increased 
incidence of Guillain-Barre syndrome in the first six weeks, 
especially the first two weeks, after vaccination," he tells WebMD.

Still, the risk is extremely low: 26 in 10 million in the first two 
weeks and 30 in 10 million in the first six weeks after vaccination. 
That compares to 5 in 10 million odds in the general population, Souayah says.

In response to the study, a spokesperson for Merck, which makes 
Gardasil, notes that the CDC says that "the data do not currently 
suggest an association between Gardasil and GBS."

The findings were presented at the annual meeting of the American 
Academy of Neurology.


Guillain-Barre Syndrome and Vaccination

Guillain-Barre syndrome is a rare nervous system disorder in which 
the body's immune system attacks part of the nervous system. This 
immune system malfunction is usually triggered by an infection, such 
as with <http://www.webmd.com/cold-and-flu/default.htm>flu virus, or 
other illness. Occasionally, surgery or vaccinations will trigger the syndrome.

The link between Guillain-Barre syndrome and vaccinations isn't 
clear. But researchers say concerns emerged after an association was 
noticed during the 1976-1977 " 
<http://www.webmd.com/cold-and-flu/swine-flu/default.htm>swine flu" 
season. Since then, "there is always a concern when any vaccine 
program is introduced," says Ken Gorson, MD, a neurologist at Tufts 
University/St. Elizabeth's Medical Center in Boston.

In 
<http://www.webmd.com/parenting/news/20070105/cdc-updates-kids-vaccine-schedule>January
 
2007, the CDC added Gardasil to its routine childhood 
<http://children.webmd.com/vaccines/immunizations-vaccines-power-of-preparation>immunization
 
schedule. The CDC recommended Gardasil for all girls aged 11-12 and 
even for girls as young as 9, with catch-up doses for girls and women 
13-26 who hadn't been vaccinated earlier.

<http://www.webmd.com/sexual-conditions/HPV-Genital-Warts/>HPV is a 
sexually transmitted virus, with dozens of strains.

As of December 2008, more than 23 million doses of the vaccine were 
distributed, according to Souayah.


Guillain-Barre Syndrome and Vaccination: Study Details

For the study, researchers examined data from the Vaccine Adverse 
Event Reporting System (VAERS), which is managed by the CDC and the FDA.

There were 53 cases of Guillain-Barre reported after 
<http://www.webmd.com/sexual-conditions/hpv-genital-warts/hpv-vaccines-human-papillomavirus>HPV
 
vaccination in the United States from 2006 to 2008. In nearly 
three-fourths of cases, the disorder developed within six weeks after 
vaccination. More than one-third of cases occurred in the first two weeks.

The fact that so many cases occurred in the first few weeks after 
vaccination strongly suggests that "some cases are caused by the 
vaccine," Souayah says.


Merck spokeswoman Pamela Eisele points to the FDA and CDC statement 
on the safety of Gardasil: "The FDA and CDC have reviewed the reports 
of GBS that have been submitted to VAERS. To date, there is no 
evidence that Gardasil has increased the rate of GBS above that 
expected in the population."

Gorson says much more study is needed before any conclusions 
regarding Gardasil and GBS can be made. Plus, the chance of 
developing Guillain-Barre syndrome, regardless of whether you're 
vaccinated, is extremely low, he says.

"I would discourage women to look for the problem in the first six 
weeks after vaccination as it will just cause undue 
<http://www.webmd.com/anxiety-panic/default.htm>anxiety. 
Guillain-Barre syndrome is not subtle, with weakness, paralysis, 
balance problems, and numbness and tingling of the limbs developing 
in a rapidly progressing fashion. It won't be missed," Gorson tells WebMD.

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