Yourlawyer.com (Guillain-Barre Syndrome News) http://www.yourlawyer.com/topics/overview/Guillain_Barre_Syndrome Tue, 29 Jul 2014 19:04:19 -0400 Tue, 29 Jul 2014 19:04:19 -0400 pixel-app en Illness Reported After H1N1 Vaccine http://www.yourlawyer.com/articles/title/illness-reported-after-h1n1-vaccine Thu, 12 Nov 2009 00:00:00 -0500 http://www.yourlawyer.com/articles/title/illness-reported-after-h1n1-vaccine Guillain-Barre syndrome, MSNBC is reporting.

Jordan McFarland (14), is wheelchair-bound and developed severe headaches, spasms, and leg weakness, said MSNBC, and is expected to need to use a walker for up to six weeks and will have to undergo “extensive physical therapy,” following his shot. Jordon is not the only case, and this is not the first time a swine flu vaccine has been associated with the serious disorder, noted MSNBC. In 1976, there were increased reports of Guillain-Barre connected to that year’s swine flu vaccine; to date, the U.S. Centers for Disease Control and Prevention (CDC) has received five reports of the syndrome since October 6, reported MSNBC, in addition to Jordan’s.

While less than what is expected, according to Dr. Claudia J. Vellozzi, deputy director of immunization safety, about 40 million H1N1 vaccine doses have been made available, said MSNBC. Guillain-Barre is expected to develop in about one in each one million regular flu vaccinations, with one more case of the syndrome in every 100,000 people receiving swine flu vaccinations in 1976, said the CDC, reported MSNBC.

And, while the CDC says it has received some 1,700 reports of adverse events associated with the new swine flu shot—four percent, or 68, were deemed serious—Guillain-Barre Syndrome is considered one of the most severe of the reactions, said MSNBC. Experts believe the adverse effects experienced with the H1N1 virus are more serious than the vaccine.  “The H1N1 illness is making lots of children very ill," Vellozzi said. Over 4,000 have died, to date, said MSNBC, citing recent CDC estimates.

Since the implementation of the H1N1 inoculation program, the CDC has issued warnings about an array of conditions, such “miscarriage, heart attack and even GBS” that can take place with or without the vaccine and has urged the public to report any potential side effects, but not to assume the vaccine is connected, said MSNBC.

Barbara Lowe Fisher, president of the National Vaccine Information Center in Vienna, Virginia, explained that adverse events are underreported with a mere one-to-ten percent reported to the government's Vaccine Adverse Event Reporting System (VAERS), according to MSNBC. While a law implemented in 1986 mandates reactions be reported, there are no so-called sanctions for failing to report, said Fisher; the CDC confirmed that reporting is voluntary, noted MSNBC.

The Associated Press (AP) just reported that, according to federal health officials, at least 4,000 Americans have died from the swine flu, which is an increase of four-fold over what is being released in estimated figures. The AP noted that the increased figure was previously reported by The New York Times and also includes fatalities resulting from swine flu complications, such as infections and pneumonia.

The AP also said that, according to the CDC, "many millions" of Americans have been diagnosed with the pandemic virus since in April and that the World Health Organization (WHO) said physicians should not wait for lab results when dealing with pregnant women and at-risk groups who may have the swine flu.

]]>
Flu shot linked to risk http://www.yourlawyer.com/articles/title/flu-shot-linked-to-risk Tue, 14 Nov 2006 00:00:00 -0500 http://www.yourlawyer.com/articles/title/flu-shot-linked-to-risk
Dr. David Juurlink of the University of Toronto reported in the Archives of Internal Medicine that the yearly flu shot is associated with a small but noteworthy risk. He said the shots can lead to hospitalization because of a neurological condition called Guillain-Barré syndrome.

The potentially debilitating disorder is characterized by nerve inflammation and muscle weakness. It can occur after a number of infectious disorders, such as West Nile disease. The flu vaccine link though controversial has raised concerns among some scientists, but even Juurlink advised caution.

"Our results must be interpreted carefully," he said. The increased risk is extremely low about 1 in 100,000 people in the population.

Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention, said the syndrome is incredibly rare and that complications from the flu are the greater and more substantial danger.

CDC statistics document 36,000 deaths annually as a result of the flu and 200,000 hospitalizations.

Gerberding said the nation has a record supply of vaccines and Americans should strongly consider getting a shot. It is the second time in a month that she and other federal health officials have underlined the importance of influenza vaccination.

Gerberding said 77 million doses will be distributed to private physicians and clinics by the end of November. The rest of more than 100 million doses will be available by December.

Only 9 million doses will be free of mercury, Gerberding said, which is used in infinitesimal amounts as a preservative. Many groups have expressed concern about the additive known as thimerosol, which they say is linked to autism and other debilitating conditions.

Gerberding said there are no known dangers from the additive and emphasized the benefits of flu vaccination. The risk of influenza outstrips any perceived dangers with the preservative, Gerberding added, as she described the plight of a mother whose unvaccinated child died as a result of the flu.

She also encouraged people nationwide to continue lining up for shots throughout winter. "The season for vaccination does not end at Thanksgiving," she pointed out, saying that flu shots are effective even when administered in December and beyond, because flu infections often don't peak until spring.]]>
FDA and CDC Update Information on Menactra Meningococcal Vaccine and Guillain Barre Syndrome http://www.yourlawyer.com/articles/title/fda-and-cdc-update-information-on-menactra-meningococcal-vaccine-and-guillain-barre-syndrome Fri, 20 Oct 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/fda-and-cdc-update-information-on-menactra-meningococcal-vaccine-and-guillain-barre-syndrome
GBS is a serious, rare neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in leg, arm and other muscles that can be severe and require hospitalization. GBS usually resolves on its own, however some people may have residual neurological deficits.

To date a total of 15 confirmed cases of GBS among individuals 11-19 years of age occurring within six weeks of vaccination with Menactra have been reported to the Vaccine Adverse Event Reporting System (VAERS). Two additional cases have been confirmed in persons 20 years of age and older. All individuals are reported to be recovering or have recovered. While the cases reported suggest a small increased risk of GBS following immunization with Menactra, the limitations in VAERS, and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. At this time, CDC and FDA cannot determine with certainty whether Menactra does increase the risk of GBS in persons who receive the vaccine and, if so, to what degree (the current data suggests an estimated possible increase of approximately 1.25 GBS cases for every million vaccinnees, but this estimate has many uncertainties).

Menactra prevents meningococcal disease, which is a major cause of bacterial meningitis (an infection of the lining of the brain and spinal cord) and blood stream infections. Meningococcal disease affects approximately 1 in 100,000 people ages 11-19 annually. The infection can be life threatening: 10-14 percent of cases are fatal and 11-19 percent of survivors may have permanent disability.

At the present time, there are no changes in recommendations for vaccination and individuals should continue to follow their doctors' recommendations. CDC’s Advisory Committee on Immunization Practices will be reviewing this information at its next meeting, October 25-26, 2006.

FDA and CDC are continuing to monitor the situation and are asking any persons with knowledge of any possible cases of GBS occurring after receiving Menactra to report them to VAERS to help the agencies further evaluate the matter. Individuals can report to VAERS on the web at http://www.vaers.hhs.gov or by phone at 1-800-822-7967.

Studies of more than 7,000 recipients performed by sanofi pasteur before the licensure of the vaccine showed no GBS cases. An analysis of Menactra use within the Vaccine Safety Datalink, a database of vaccine information from eight large managed care organizations, revealed that as of September 20, 2006, a total of 126,506 doses had been delivered and, of those, no cases of GBS have been observed among vaccine recipients ages 11-19 within six weeks of vaccination. Additional, larger studies are being planned to provide a more definitive assessment.]]>
Meningitis vaccine may have link to neurological disorder http://www.yourlawyer.com/articles/title/meningitis-vaccine-may-have-link-to-neurological-disorder Mon, 10 Oct 2005 00:00:00 -0400 http://www.yourlawyer.com/articles/title/meningitis-vaccine-may-have-link-to-neurological-disorder
The vaccine, called Menactra, helps protect against certain strains of meningococcal bacteria. Produced by Sanofi Pasteur, the vaccine was approved for use in January. While another vaccine was already on the market, doctors had hoped that the new formulation might offer longer immunity.

Since Oct. 4, officials at the U.S. Centers for Disease Control and Prevention have received reports that five teenagers, all ages 17 and 18, developed symptoms of Guillain-Barre syndrome within six weeks of getting the new vaccine. About 2.5 million doses of the vaccine have been sold.

GBS is a disorder in which the body's immune system attacks part of the peripheral nervous system.

While the number of cases is not apparently abnormal, officials are concerned because they occurred so quickly after the teens got the shots, Dr. Nancy Rosenstein of the CDC told experts gathered Friday in San Francisco for the annual meeting of the Infectious Diseases Society of America.

The CDC issued an alert Thursday night in its Morbidity and Mortality Weekly Report that physicians should be acutely aware of any symptoms of GBS in patients newly vaccinated with Menactra. Because no link between the two has been established, officials are recommending continued use of the vaccine.

A similar vaccine has been used in Britain, where 30 million doses have been administered with only five cases of GBS reported.

In a statement, Sinofi Pasteur said, "No causal relationship has been established between Menactra vaccination and GBS, and there remain several possible explanations for the reported cases of GBS."]]>
Menactra Vaccine May Have Tie to Brain Illness http://www.yourlawyer.com/articles/title/menactra-vaccine-may-have-tie-to-brain-illness Mon, 03 Oct 2005 00:00:00 -0400 http://www.yourlawyer.com/articles/title/menactra-vaccine-may-have-tie-to-brain-illness
It is not known yet whether these cases were caused by the vaccine or are coincidental. 

Guillain Barre Syndrome (GDS) is a serious neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections.  GBS typically causes increasing weakness in the legs and arms that can be severe and require hospitalization.

Menactra protects against bacterial meningitis, and the vaccine is recommended for college students living in dormitories because close contact is the biggest risk factor for the spread of bacterial meningitis.

Because the FDA and the DCD are not able to determine if any or all of the cases were due to the vaccination, The FDA is recommending that individuals continue to follow their doctors’ recommendations with regard to receiving Menactra. 

The five reported cases of GBS followed administration of Menactra in individuals living in New York, Ohio, Pennsylvania and New Jersey.  All five patients were 17 or 18 years of age and developed symptoms two to four weeks after being vaccinated.  All individuals are in recovery. 

More than 2.5 million doses of Menactra vaccine have been distributed to date, and the rate of GBS following administration of the vaccine is what might have been expected to occur by coincidence, that is, even without the vaccination.  However the timing of the events is of concern, stated the FDA, and vaccine adverse events are not always reported, so there may be additional cases that have occurred.

Prior to the licensing of Menactra, Sanofi Pasteur studied more then 7000 recipients of Menactra.  No GBS cases were found.  The CDC also conducted a rapid study using available health care organization databases and found no cases of GBS to have been reported among 110,000 Menactra recipients.]]>
FDA Probes Vaccine's Tie to Brain Illness http://www.yourlawyer.com/articles/title/fda-probes-vaccines-tie-to-brain-illness Fri, 30 Sep 2005 00:00:00 -0400 http://www.yourlawyer.com/articles/title/fda-probes-vaccines-tie-to-brain-illness 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.

]]>
FDA and CDC Issue Alert on Menactra Meningococcal Vaccine and Guillain Barre Syndrome http://www.yourlawyer.com/articles/title/fda-and-cdc-issue-alert-on-menactra-meningococcal-vaccine-and-guillain-barre-syndrome Fri, 30 Sep 2005 00:00:00 -0400 http://www.yourlawyer.com/articles/title/fda-and-cdc-issue-alert-on-menactra-meningococcal-vaccine-and-guillain-barre-syndrome The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are alerting consumers and health care providers to five reports of Guillain Barre Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra), manufactured by Sanofi Pasteur.

It is not known yet whether these cases were caused by the vaccine or are coincidental. FDA and CDC are sharing this information with the public now and actively investigating the situation because of its potentially serious nature.

Guillain Barre Syndrome (GBS) is a serious neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in the legs and arms that can be severe and require hospitalization.

Meningococcal infection, which Menactra prevents, is a major cause of bacterial meningitis, affecting approximately 1 in 100,000 people annually. The infection can be life threatening: 10-14 percent of cases are fatal and 11-19 percent of survivors may have permanent disability.

According to Jesse Goodman, MD, Director of FDA’s Center for Biologics Evaluation and Research, at the present time there are no changes in recommendations for vaccination; individuals should continue to follow their doctors' recommendations. FDA and CDC are not able to determine if any or all of the cases were due to vaccination. The current information is very preliminary and the two agencies are continuing to evaluate the situation.

Because of the potentially serious nature of this matter, FDA and CDC are asking any persons with knowledge of any possible cases of GBS occurring after Menactra to report them to the Vaccine Adverse Event Reporting System (VAERS) to help the agencies further evaluate the matter.

The five cases of GBS reported following administration of Menactra occurred in individuals living in NY, OH, PA, and NJ. All five patients were 17 or 18 years of age and developed weakness or abnormal sensations in the arms or legs, two-four weeks after vaccination. All individuals are reported to be recovering or to have recovered. More than 2.5 million doses of Menactra vaccine have been distributed to date. The rate of GBS based on the number of cases reported following administration of Menactra is similar to what might have been expected to occur by coincidence, that is, even without vaccination. However, the timing of the events is of concern. Also, vaccine adverse events are not always reported to FDA so there may be additional cases of which we are unaware at this time.

Prelicensure studies conducted by Sanofi Pasteur of more than 7000 recipients of Menactra showed no GBS cases. CDC conducted a rapid study using available health care organization databases and found that no cases of GBS have been reported to date among 110,000 Menactra recipients.

]]>
Reported Side Effects Deal Blow to Meningitis Vaccine http://www.yourlawyer.com/articles/title/reported-side-effects-deal-blow-to-meningitis-vaccine Fri, 23 Sep 2005 00:00:00 -0400 http://www.yourlawyer.com/articles/title/reported-side-effects-deal-blow-to-meningitis-vaccine     
"I was sitting in my favorite restaurant in Rocklin having breakfast," said the Loomis man, whose son, John, died in 2000 from meningococcal meningitis. "I broke down. It was this calm, this peace came over me."

Although it was too late for his son, he thought, routine vaccination would mean that millions of other youngsters and their families never would have to confront the devastation of meningococcal disease.

The promise of mass protection, however, suffered a setback recently with news of a potential, but unproven, association between the vaccine, Menactra, and a serious neurological disorder called Guillain-Barr syndrome, or GBS. The information initially caused some local pediatricians to suspend use of the vaccine.

The concerns were prompted by an alert issued Sept. 30 by the federal Centers for Disease Control and Prevention. It noted five youngsters had come down with GBS soon after getting the Menactra vaccine. A sixth case was reported after the alert was sent out.

The initial five cases were in patients 17 or 18 years old, and all developed weakness or abnormal sensations in their arms or legs two to four weeks after the shot. Each of the cases remains under investigation. All of the teens are recovering.

Federal health officials stress that, while the timing of the events is cause for concern, the number of cases so far reported among teens immunized with Menactra is no greater than what would be expected to occur without vaccination. They note, also, that no cases of Guillain Barr cropped up during clinical trials of the vaccine.

"It is something we need to look at very carefully, and that's what's being done," said Dr. Joseph Bocchini, chief of pediatric infectious diseases at Louisiana State University Health Sciences Center and a member of the infectious disease committee of the American Academy of Pediatrics.

"In the interim, we have recommended those individuals at risk for meningococcus infection should continue being given the vaccine because that is a very severe, life-threatening disease."

Menactra, approved by the FDA in January, protects against four types of Neisseria meningitidis, the bacterium that causes a significant percentage of meningococcal infections.

The infection can result in meningitis the inflammation of the lining of the brain and spinal cord and menigococcemia, a related blood infection. Both can be deadly. Meningococcal disease is fatal in 10 percent of cases. Of those who survive, up to one in five will have permanent problems such as hearing loss, neurological damage and limb amputation.

Although meningococcal disease is rare, the Sacramento region had a frightening spate of cases in 2000 and 2001 when five otherwise healthy teenagers, including John Garcia, died after contracting the infection. The deaths spurred state legislation to boost awareness of the disease, and in 2001, several colleges began recommending the vaccine an earlier version called Menomune to all incoming freshmen.

But the coup for parents such as Jim Garcia came with FDA approval of an improved vaccine and the CDC's subsequent recommendation for its use in 11-and 12-year-olds, those entering high school and college freshmen planning to live in a dorm, among other groups.

"We were elated for what part we played in it all of us who came together and put pressure on the CDC," Garcia said.

He said he was shocked to learn of the potential link between Menactra and GBS, ironically the disease that took his father's life. "But until further tests are done, and they can prove (a link), we may have vaccine out there that can prevent a lot of people from contracting meningococcal meningitis."

GBS is a fairly mysterious disease in that its cause is not well understood and there is no real cure, although treatments developed in recent years are effective in reducing the symptoms.

Dr. Robert Miller, a neurologist at California Pacific Medical Center in San Francisco and a member of the International GBS Foundation's advisory board, said GBS is an immune system abnormality.

"The immune system gets stirred up by something  an infection, an immunization, a surgical procedure or a traumatic injury," he said. The swine flu vaccine, used during an outbreak in 1976, was shown to trigger GBS.

He said scientists believe the body's immune system overreacts to the foreign invader. In the case of GBS, the immune response inflames the nerves and degrades the surrounding myelin sheath, inhibiting the nerve's ability to transmit impulses.

"And when you can't transmit an impulse, the muscle won't react. It can cause paralysis and it can be permanent," he said.

The majority of people recover, he said, but it can take weeks or months.

In response to the cases of GBS reported to the FDA in youngsters who had received Menactra, the CDC revised its recommendations, but only slightly. The agency now advises that anyone who has had GBS in the past should talk to their doctor before getting the vaccine.

Rose Kwett lost her daughter, MaryJo, a Loretto High School student, to meningococcemia in 2000.

She has been working since to educate students about the disease, and said the greater threat is the vaccine manufacturer's inability to keep up with demand.

Sanofi Pasteur has distributed about 2.5 million doses of Menactra, according to the FDA. About 24 million children are eligible for the immunization.

Even Kwett's son, now 17, was unable to get the vaccine at his last doctor's visit because the stocks were gone, she said.

"(The manufacturer) needs to get to it," she said. "My son is due."]]>
http://www.yourlawyer.com/topics/overview/Guillain_Barre_Syndrome Fri, 23 Sep 2005 00:00:00 -0400 http://www.yourlawyer.com/topics/overview/Guillain_Barre_Syndrome Guillain-Barre Syndrome Exposure Injury Lawsuits

Guillain-Barre Syndrome | Lawsuits, Lawyers | Bacterial Infection

Guillain Barre Syndrome (GBS) is a severe neurological disorder that may occur frequently in healthy individuals, either spontaneously or after certain infections. Guillain Barre Syndrome generally causes increasing weakness in the legs and arms that can be severe and require hospitalization. Guillain Barre Syndrome is an inflammatory disorder of the peripheral nerves.

Guillain-Barre Syndrome is a rare disorder; its incidence is approximately 1 to 2 cases in every 100,000 people per year. Men and women, young and old, are equally prone to contracting Guillain-Barre Syndrome. A small number of cases have been known to occur after medical procedures such as minor surgery.

The causes of Guillain-Barre Syndrome are not known; however, in about half of all cases, the onset of the Syndrome follows a viral or bacterial infection such as the following: gastrointestinal viral infection; infectious mononucleosis; viral hepatitis; campylobacteriosis (usually from eating undercooked poultry); porphyria (rare disease of red blood cells); flu or common cold.

The initial symptoms of Guillain-Barre Syndrome are usually numbness or tingling (paresthesia) in the toes and fingers with progressive weakness in the arms and legs over the next few days. Some patients experience paresthesia only in their toes and legs; others only experience symptoms on one side of the body.

The symptoms may stay in this stage, causing only mild difficulty in walking, requiring crutches or a walking stick. Sometimes the illness progresses, leading to complete paralysis of the arms and legs. About one quarter of the time, the paralysis continues up the chest and freezes the breathing muscles, leaving the patient dependent on a ventilator. If the swallowing muscles are also affected, a feeding tube may be needed.

Recently the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) reported they are investigating five reports of Guillain Barre Syndrome in teenagers who have taken Menactra, a new vaccine for meningitis.

Legal Help For Victims Affected By Guillain-Barre Syndrome

If you or a loved one has taken prescription medications to treat Meningitis and been diagnosed with Guillain Barre Syndrome, please fill out the form at the right for a free case evaluation by a qualified defective drug attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).

]]>