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Swine flu shots probed for link to sleep disorder

European health chiefs have launched a safety probe into a swine flu vaccine given to thousands of patients here.

Doctors are examining a possible link between a widely used vaccine Pandemrix and the sleeping disorder narcolepsy.

The European Medicines Agency said it was looking into the drug after a limited number of cases of narcolepsy were reported, mostly in Sweden and Finland.

It said that it had launched a review of Pandemrix on the request of the European Commission to investigate whether there is a link between cases of narcolepsy and vaccination with Pandemrix.

Pandemrix, an influenza vaccine, has been used since September 2009 for vaccination against H1N1 influenza in at least 30.8 million Europeans.

It was one of two vaccines made available for use in Ireland.

Narcolepsy is a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly.

Its precise cause is unknown, but it is generally considered to be triggered by a combination of genetic and environmental factors, including infections.

The European Medicines Agency said that: "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."

Its committee will consider the number of cases that would normally be expected to be diagnosed.

Made by GlaxoSmithKline, the vaccine was used in Ireland the height of the flu pandemic.

By Feburary this year, the Health Service Executive was primarily giving the Pandemrix vaccine at all locations and one dose of the vaccine was sufficient for the vast majority of adults and children. Only people with immunosupprssion needed a second dose of the vaccine.

However in England, where six million doses of the swine flu vaccine were used, no cases of narcolepsy have been reported following vaccination, and it remains available for use as recommended.

The UK's Medicines and Healthcare products Regulatory Agency said it was evaluating case reports in Europe of patients developing narcolepsy after taking Pandemrix.

Meanwhile, the Department of Health here stressed last year that Pandemrix and the other vaccine available for use in Irleand were considered equally safe and effective for use in everyone aged over six months, based on the the available scientific evidence.

It said that vaccination provided protection and the best means by which swine flu can be limited in individuals, their families and the broader community.

fdillon@herald.ie


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