Swine flu drug is linked with sleep disorder
A flu vaccine widely distributed in Scotland is under review over a possible link to narcolepsy, it has been announced.
The European Medicines Agency is investigating the swine flu drug Pandemrix after a number of those who received the vaccination in Sweden and Finland reported symptoms of the sleeping disorder.
On Tuesday, Finland’s National Institute for Health and Welfare recommended that vaccination with Pandemrix be stopped until the suspected link with narcolepsy had been thoroughly evaluated.
As there have been no such cases reported in the UK so far, use of the drug will not be suspended in Scotland.
During last year’s swine flu epidemic, Pandemrix was the most widely ordered and prescribed vaccine in Scotland, with a different vaccine, Celvapan, being given only to those with an egg allergy.
Throughout the UK, the drug was given to millions of people in high-risk groups, including children and those with conditions such as diabetes, heart disease and asthma.
The Scottish Government takes advice on the medicines it distributes from the Medicines and Healthcare products Regulatory Agency (MHRA), which yesterday emphasised the fact that no link between narcolepsy and the vaccine had yet been established.
A spokesman said: “The MHRA is aware of the case reports of narcolepsy and is evaluating these in collaboration with other EU authorities.
“After use of more than 6 million doses of swine flu vaccine in the UK, no cases of narcolepsy have been reported following vaccination in the UK. Pandemrix vaccine remains available for use as recommended.”
Narcolepsy is a rare illness, with about ten new cases per million people every year. Sufferers find it difficult to control when they sleep, resulting in them falling asleep suddenly and unexpectedly. The condition usually begins during adolescence, with the type and severity of symptoms varying from person to person.
At least 30.8 million Europeans were given Pandemrix last year at the height of the swine flu pandemic caused by the H1N1 strain of the influenza virus. After reaching the highest level on the World Health Organisation’s (WHO) warning scale, the risk of swine flu becoming a global pandemic has since fallen.
On August 10, WHO announced that most countries had now entered a post-pandemic period, as many people now have some immunity to the virus. Swine flu outbreaks and cases are expected to continue, but with the same effects as other seasonal flu viruses.
The European Medicines Agency released a statement confirming that it would be investigating the possibility of a link between Pandemrix, made by GlaxoSmithKline, and narcolepsy.
It said: “Although the cases of narcolepsy have been reported in temporal association with the use of Pandemrix, it is at present not known if the vaccine caused the disorder.
“The Agency’s Committee for Medicinal Products for Human Use will look carefully at all of the available data to determine whether there is evidence for a causal association.”
The review follows concerns raised by the agency in December that children may develop a high fever following their second dose of Pandemrix.
Patients and doctors were urged to keep watch on the temperatures of child recipients after research found that they were more likely to suffer a fever following the second dose than after the first.
It was also found that children were more likely to suffer soreness at the site of injection as well as drowsiness, irritability and loss of appetite.
Although use of the drug has not been suspended, the Scottish Government did confirm that it would not be used in the upcoming seasonal flu vaccination programme.
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