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FDA probes vaccine's tie to brain illness
Seattle Post-Intelligencer ^ | September 30, 2005 | THE ASSOCIATED PRESS

Posted on 10/03/2005 12:19:23 AM PDT by neverdem

WASHINGTON -- The government is investigating five reports of teenagers who came down with a serious neurological disorder after receiving a new vaccine against meningitis.

Doctors don't yet know whether the cases of Guillain Barre syndrome are related to the shot, called Menactra, or are coincidence, the Food and Drug Administration emphasized Friday.

The government recommends the vaccine for adolescents and college freshmen living in dormitories, and FDA said there was no reason to change that advice - but it alerted the public as a precaution.

Menactra protects against rare but devastating cases of bacterial meningitis. The shot is particularly targeted to college students, because close contact is the biggest risk factor for its spread. While there are fewer than 3,000 cases of invasive meningococcal meningitis each year, and 300 deaths, people ages 15 to 24 have the highest mortality rates, and survivors can suffer mental disabilities, hearing loss and paralysis.

Menactra is a new vaccine approved last January; an older meningitis vaccine is available, too, but doesn't provide as much protection.

Guillain Barre syndrome, or GBS, causes increasing weakness in the legs and arms, sometimes severe enough to cause paralysis. It can strike suddenly, either spontaneously or after certain infections.

The five cases reported two to four weeks after Menactra vaccination occurred in 17- or 18-year-olds in New York, Ohio, Pennsylvania and New Jersey, FDA said. All are reported to be recovering.

Studies of more than 7,000 Menactra recipients by manufacturer Sanofi-Pasteur showed no GBS cases, and more than 2.5 million doses have been administered since it hit the market, FDA said. The rate of GBS is similar to what is expected without vaccination, but the timing of the cases is of concern and warrants further investigations, FDA said.


TOPICS: Business/Economy; Culture/Society; Extended News; Government; News/Current Events; Technical; US: District of Columbia; US: Maryland; US: New Jersey; US: New York; US: Ohio; US: Pennsylvania
KEYWORDS: guillainbarre; health; medicine; menactra; meningitis; meningitisvaccine; vaccine

1 posted on 10/03/2005 12:19:25 AM PDT by neverdem
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To: neverdem

2 posted on 10/03/2005 12:38:50 AM PDT by alessandrofiaschi (Is Roberts really a conservative?)
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To: El Gato; JudyB1938; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; LadyDoc; jb6; tiamat; PGalt; ..
AP or whoever screwed up the title. This possible adverse drug reaction, Guillain Barre syndrome, causes an ascending paralysis which is a peripheral neuropathy, i.e. it doesn't involve the brain, which is part of the central nervous system. IIRC, it never involves the brain. If it does, it is the very last stage.

However, before I posted that I fortunately checked PubMed and found Brain stem auditory and visual evoked potentials in children and adolescents with Guillain-Barre syndrome

Guillain-Barre Syndrome

Flavanol-rich cocoa drink improved blood vessel function in smokers

FReepmail me if you want on or off my health and science ping list. Anyone can post any unrelated link as they see fit.

3 posted on 10/03/2005 12:42:40 AM PDT by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: Kermit the Frog Does theWatusi

Ping.


4 posted on 10/03/2005 12:54:25 AM PDT by HowlinglyMind-BendingAbsurdity
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To: neverdem

The syndrome you mentioned is one I remember over the years often hitting late teen boys.

Did the study say what sex was afflicted.

I don't here about it often now a days but I am older and not in touch with many parents of late teen boys so I would not hear it as I did raising my son.


5 posted on 10/03/2005 1:02:45 AM PDT by oceanperch (I love my Labradors Kolbe, Porter, Hunter and Yol)
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To: oceanperch

Although GB is not that common, it is less common in young people, I have been told, than it is in middle-aged people. My brother had it at age 25 and had it bad - came on fast, and before we knew it, he was on life support and spent six weeks in ICU, but recovered just about fully, with a little nerve damage to his feet.

A lady friend of mine had it bad as well, but ended up in a wheel chair with little use of her legs, and limited used of her hands.

Another male friend of mine had it and it came on very slow, and never got truly severe like my other two friends' cases did - but he was down with it a lot longer.

A well-known writer (I want to say Joseph Heller, but I'm not sure) had it, and wrote how he was thinking about suiciding if he lost use of speech from it. The paralysis never got to that point with him.


6 posted on 10/03/2005 4:36:04 AM PDT by Knitting A Conundrum (Act Justly, Love Mercy, and Walk Humbly With God Micah 6:8)
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To: neverdem
The rate of GBS is similar to what is expected without vaccination, ....

The vaccination doesn't sound very effective if that is the case.

7 posted on 10/03/2005 5:16:52 AM PDT by Mind-numbed Robot (Not all that needs to be done needs to be done by the government.)
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To: oceanperch
Did the study say what sex was afflicted.

Same-sex sex was hit hardest. :-)

8 posted on 10/03/2005 5:24:53 AM PDT by Mind-numbed Robot (Not all that needs to be done needs to be done by the government.)
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To: neverdem

This is another example of public health people allied w/ big pharma screwing everyone. When you have a problem that affects 3,000 people a year, does it pay to vaccinate hundreds of thousands? Their Hep B infant vaccination program is an even worse example.


9 posted on 10/03/2005 5:25:06 AM PDT by Pharmboy (Democrats lie because they have to.)
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To: neverdem

In 1986, a bunch of us got MMR boosters the first week our Med School class started - some of the graduate students were in those lines, too.

At least 5 or 6 of us came down with a horrible flu that sapped our energy for a month or two. One of the Grad students developed GB, with the symptoms starting about 4 days after the shots. The grad student and a couple of us were mothers who had no documentation of previous Measles vaccination or antibody testing - but we had had the measles as kids.

The grad student was told that her GB was a reaction to the vaccine, and I've always believed that our "flu" was, too.

But, we were in the same lines, and it could have just been a virus and med student - itis.

Coincidents bother me though - like the summer our little community hospital had two young men in the ICU on the ventilator with GB.

Thanks for the chocolate story, btw. Every bit of evidence to support my chocolate habit is welcome.


10 posted on 10/03/2005 6:00:56 AM PDT by hocndoc (Choice is the # 1 killer in the US. http://www.lifeethics.org/www.lifeethics.org/index.html)
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To: Knitting A Conundrum

That is odd that a writer would be suicidal over lost of speech.

If you think about it.

But then KV and I have been using augmented communication skills for 26yrs so not having oral speech is not something we see as life ending.


11 posted on 10/03/2005 6:02:41 AM PDT by oceanperch (I love my Labradors Kolbe, Porter, Hunter and Yol)
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To: oceanperch
Did the study say what sex was afflicted.

It wasn't a study. The FDA News Release did not mention gender.

12 posted on 10/03/2005 9:30:26 AM PDT by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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