Researchers in Finland have linked GlaxoSmithKline’s (NYSE: GSK) H1N1 vaccine to increased cases of a sleeping disorder among children.

GSK said drawing conclusions from the data at this time would be “premature” and noted that a larger study is underway in Europe.

“Over 31 million doses of Pandemrix have been administered worldwide in 47 countries,” GSK said in a statement. “A total of 162 cases of narcolepsy in people vaccinated with Pandemrix have been reported to GSK as of 31 January 2011; with 70 percent of these cases of narcolepsy originating from Finland and Sweden.”

According to a Reuters report, Finland’s national health institute reported preliminary research that found children ages 4 to 19 who took the H1N1 vaccine Pandemrix were nine times more likely to suffer from narcolepsy, a rare disorder that causes people to fall asleep suddenly and unexpectedly. Its cause is unknown.

The institute noted that the data is not yet confirm. It also said the narcolepsy was “most likely” the result of Pandemrix and another factor or more.

Reuters noted that the European medical Agency, which reviews drugs in the European Union, has been studying a possible Pandemrix-narcolepsy link since last September.

“There is really not enough data at this point in time to determine anything,” a spokesperson for the EMA told Reuters. “For the time being … the benefit-risk balance of Pandemrix remains positive.”

GSK, which maintains its US headquarters in RTP, issued a lengthy statement about the Finnish report.

“This investigation is independent of a broader ongoing European Medicines Agency (EMA) investigation initiated in 2010,” the company said. “GSK is reviewing the report and believes it would be premature to draw any conclusions on a potential association between Pandemrix and narcolepsy until this European investigation has been completed.

“Patient safety is of paramount importance to GSK and we have been working closely with the EMA and other national regulatory organizations to better understand the situation since reports of narcolepsy after vaccination with Pandemrix were first received. The company recognizes the value of ongoing independent research to add further information.”

For the complete statement, read here.

Read the Reuters report here.

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