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Flu shot linked to extremely rare side-effect, Canadian study shows
Sheryl Ubelacker - CP
November 15, 2006
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In extremely rare cases, getting vaccinated against the flu can trigger a potentially debilitating neurological disorder known as Guillain-Barre syndrome, say Canadian researchers, although they stress their finding should not make people shy away from getting their shots.
"It is very, very small," Dr. David Juurlink, lead author of the study by the Institute for Clinical Evaluative Sciences (ICES), said Monday of the risk of Guillain-Barre syndrome (GBS). "It's roughly for every million people vaccinated, we're talking about one or two extra cases of Guillain-Barre syndrome that would not have happened otherwise."
In other words, explained Juurlink, "the risk for an individual patient here is marginally greater than being struck by lightning. What we don't want is people running away from the flu vaccine because of this infinitesimal risk of a bad side-effect."
So, given that the potential danger is so tiny, why mention it all?
"This a material risk, this is not some runny nose or rash that goes away," said Juurlink, an ICES scientist and an internal medicine and clinical pharmacology specialist at Sunnybrook Health Sciences Centre in Toronto. "It's an illness that is potentially fatal and I think it speaks to the importance of . . . the process of informed consent."
"I think the job for doctors and for us as scientists is to try to convey this risk so that people know what they're getting into, that they're aware of the meaningful risks of the vaccine. But at the same time, balance that message with a discussion of the benefits."
Commenting on the study, Dr. Barbara Yaffe, associate medical officer of health for Toronto, said the research confirms previous evidence linking vaccinations to a tiny boost in risk for GBS. It is among the risks and benefits outlined to anyone getting flu shots at Toronto public health clinics, which began providing free vaccinations against this year's likely flu strains on Monday, she said.
"It is important for people to know that this is an extremely rare disease and there is a very slight increased risk . . . However, overall the benefits of this vaccine far outweigh any of the risks. And we know that the vaccine prevents 70 to 90 per cent of infections in healthy people."
Not getting vaccinated could lead to a miserable bout of the flu - including aching muscles, respiratory symptoms and fever - that will eventually run its course. But for some people, influenza can be deadly. Each year, between 500 and 1,500 Canadians die from complications of the flu, most of them elderly and young children.
"We know that the vaccine can prevent 80 to 90 per cent of deaths in people over 65 years of age in (long-term care) institutions," Yaffe said.
Contrast that with the small risk of developing Guillain-Barre syndrome, a rare condition that typically affects about 10 per one million people worldwide. The disorder occurs when immune system cells mistakenly attack nerve cells that support the muscles, usually beginning in the legs.
Initial symptoms may include tingling in the feet and weakness in the legs. Untreated, its effects can spread throughout the body. In most severe cases, GBS can lead to paralysis and even death, although the majority of people who develop GBS recover with treatment, Juurlink said.
"This is something that could change or conceivably end someone's life, even though it is extremely, extremely rare. It's therefore something to be aware of," he said. "If they got the vaccine and within a few weeks they start getting these symptoms, they should seek medical attention promptly and get treatment."
The study, published in Monday's issue of the Archives of Internal Medicine, analyzed hospital admission records across Ontario between 1993 and 2004. The researchers identified 1,601 hospital admissions for Guillain-Barre syndrome, 269 of which occurred within 43 weeks of the patient receiving a flu vaccination in October or November.
Patients were about 1.5 times as likely to be hospitalized for GBS in the two to seven weeks after vaccination than they were 20 to 43 weeks later, the study found.
In a second analysis, the researchers looked at the 2,173 hospital admissions due to GBS that occurred between 1991 and 2004 to see if there was any spike in cases after 2000, when universal access to free flu shots began in the province.
Juurlink said no significant difference in the hospitalization rate was found after the immunization program began.
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