Tamiflu fears

Sun2surf: KUALA LUMPUR: Malaysia will go ahead with the purchase of RM4 million worth of the anti-flu drug Tamiflu despite safety fears expressed by European medicines regulators.
The Europeans have ordered a safety check on Tamiflu following reports that two teenage boys died in Japan in apparent suicides after taking the drug.
Health Ministry director-general Datuk Dr Ismail Merican told theSun yesterday the government will buy the drug despite the safety concerns.
"The deaths could be isolated cases," he said. "Proper findings have to be documented on the cause of the boys' deaths before a conclusion could be made on Tamiflu."
Ismail said Malaysia will go ahead with its plan to acquire the first batch of Tamiflu, enough to treat some 60,000 patients, in case of an outbreak of the deadly H5N1 bird flu.
"We will monitor and study any further reports. If need be, we will review the decision," he said.
The government has decided to stockpile enough of the drug to treat at least 10% of the population in the event of a bird flu epidemic.
According to a report by The Independent of London on Monday, the deaths of the two Japanese boys have raised safety fears about the only weapon the world possesses to counter a threatened pandemic of avian flu.
The deaths are not linked and occurred a year apart.
The report said the Japanese health ministry issued a warning in June 2004 about psychological and neurological disorders linked with Tamiflu, with an instruction that doctors should be alerted.
Tamiflu is made by Roche, the Swiss-based phar maceutical company.
The report quoted a spokeswoman for Roche as saying: "We shared the information (about the Japanese deaths) with drug regulatory authorities around the world and they did not think it warranted any change in the product information."
In a statement, the company said it continued to monitor the safety of the drug and reported any adverse events to regulatory authorities.
"Tamiflu has been shown in clinical studies and in routine clinical use to have a good safety profile. It has been used by over 30 million people worldwide," the statement added.
According to The Independent, a spokesman for the European Medicines Evaluation Agency, which licenses drugs in the European Union, including the UK, said the agency had been aware of the first death but not the second.
"The company (Roche) has been asked to closely follow reports of psychological disorders, delusional states and abnormal behaviour linked with the drug," the spokesman said.
"At the moment, there is no warning (about this) in Europe and we need to establish if there is any link."
The spokesman said the effects of the drug had to be distinguished from the effects of the flu.
"Influenza can itself cause confusion and it can be difficult to tell whether (the mental state) is the effect of the Tamiflu or of the illness."
The Phar maceuticals and Medical Devices Agency in Japan has received reports of 64 cases of psychological disorders linked to the drug between 2000 and 2004, according to the Tokyo news agency Kyodo.
The two Japanese boys who died in separate accidents were reported to have exhibited abnormal behaviour after taking the drug, ending in their deaths.
In the first case, a 17-year-old student, who was at home alone, ran out of the house and jumped over a railing into the path of a truck in February 2004 shortly after taking the medicine.
In the second case, a junior high school student fell from the ninth floor of his apartment building in February 2005.
Chugai Pharmaceuticals Ltd, the Japanese operating company for Roche, said: "We reported these cases to the health ministry as a link between the deaths and the drug could not be ruled out."
The Independent said that in the UK, Tamiflu has been little used since its launch in 2003 and there have been only 41 "yellow card" reports of adverse reactions involving 161 separate sideeffects linked with it.
One case was of agitation and two were of "confusional state".
Under the yellow card system, doctors record any symptoms that could be linked with a drug.
The reports are intended to provide early warning of possible problems with a drug and do not show a causal link.