13 November 2005
Tokyo – Japan’s health ministry says it plans to reissue a warning of dangerous behavioral side effects linked to the anti-influenza drug Tamiflu. This comes amid reports that several children in Japan died after taking the medication. Governments around the world are stockpiling the medicine amid growing fears of a possible human pandemic of avian influenza.
Japan’s health ministry says it is looking into reports of a number of sudden deaths of young people who had taken prescribed dosages of Tamiflu.
The ministry confirms that it has concluded that the death of one boy was the result of side effects from the drug. The ministry says it has found 64 cases of psychological disorders linked to the drug in the past four years.
Dr. Rokuro Hama, head of the Japan Institute of Pharmaco-Vigilance, says he has investigated eight suspicious deaths of children aged between two and 17 over the past three years, which he thinks are linked to Tamiflu. He reported his findings Saturday at a meeting of the Japan Society of Pediatric Infectious Diseases.
Dr. Hama said Sunday that Tamiflu appears to be similar to other powerful drugs that can cause behavioral changes.
“These are tranquilizers, sedatives or hypnotics. These cause discontrol or disregulation of the central nervous system. So it may cause very bizarre phenomenon or behavior,” said Dr. Hama.
Investigators say in one case last year, a 17-year-old boy, after taking the medication, left his home during a snowstorm, and jumped in front of a truck and died.
Earlier this year, a 14-year-old boy, after taking one Tamiflu capsule, jumped or fell from the ninth floor of an apartment building.
Doctors say in both cases the boys had not exhibited any abnormal behavior before taking Tamiflu.
Yuji Yamashita of Chugai Pharmaceutical, the Japanese distributor for Tamiflu, said Sunday that the company had notified the health ministry about two deaths involving teenage boys. However, Mr. Yamashita said he had no knowledge of any other cases of psychological side effects the ministry has tracked.
Tamiflu, which has the generic name of oseltamivir phosphate, is produced by Roche, based in Switzerland. The medication inhibits the growth of flu virus in humans.
In Japan, the medication comes with a warning alerting patients to the possibility of impaired consciousness, abnormal behavior, hallucinations, and other psychological and neurological symptoms.
But Dr. Hama at the Institute of Pharmaco-Vigilance says because Tamiflu is a new drug, most health care professionals wrongly conclude behavioral changes are the result of delirium caused by high fever.
Dr. Hama says the health ministry’s initial alert last year received little notice, even among medical professionals.
“It was not reported, distributed through the mass media, so doctors do not notice that warning,” he said.
In other countries, including the United States, there is no such explicit warning with the medication.
Roche, in its consumer information, says there have been cases of seizures and confusion in patients who have taken Tamiflu but, as with a number of other side effects, “it is not possible to reliably estimate their frequency or establish a causal relationship to Tamiflu exposure.”
Roche officials at its headquarters in Switzerland and the United States were not available Sunday to comment directly on the new warning from Japan. However, a company statement issued Sunday said Tamiflu has been shown to have a “good safety profile”. Roche says it monitors reports of side effects but says they must be considered in the context of flu symptoms, which includes high fevers that can lead to neurological complications.
Japan, like many other nations, is boosting its stockpile of Tamiflu, in case there is a flu pandemic in the next few years. The government is trying to acquire 250 million capsules to cover treatment for 25 million people
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More Tamiflu deaths
I posted a few days ago about 2 deaths of Japanese teenagers on olsetamivir (Tamiflu) and was skeptical of the connection.
There are now additional cases with 12 total suspected deaths in addition to instances of non-fatal behavioral changes (the first two deaths were trauma suspected to be secondary to unusual behavior brought on by use of the medicine):
• An update by FDA staff also includes reports of 32 “neuropsychiatric events” associated with Tamiflu, all but one experienced by Japanese patients. Those cases included delirium, hallucinations, convulsions and encephalitis.
High fever from influenza can cause delirium, convulsions and viral infections cause many cases of encephalitis, so most or all of these events may well be unrelated to Tamiflu.
In addition, the drug is most widely used in Japan, so it’s not surprising possible side effects are emerging there:
• Of 32 million people treated with Tamiflu since its approval in 1999, 24 million were in Japan.
The additional cases, both deaths and non-fatal cases of unusual neurologic events and strange behavior certainly raise my concern. However, overall safety data remain reassuring:
• Roche said that several studies in the United States and Canada had shown that the death incidence rate of influenza patients who took Tamiflu was far below those who did not.
So far, these reports wouldn’t change my view that olsetamivir is safe and effective, especially in the case of a pandemic.
http://doctorandy.blogspot.com/2005/11/more-tamiflu-deaths.html
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Japan warns of Tamiflu deaths
• November 12, 2005 – 3:44PM
Japan’s health ministry has warned the anti-flu drug Tamiflu can induce strange behaviour leading to accidental death following the deaths of two teenagers who took the medicine, news reports said.
One 17-year-old Japanese high school student jumped in front of a truck in February 2004 shortly after taking the medicine, while another younger school student is believed to have fallen from the ninth floor of his apartment building this February, the Mainichi newspaper and Kyodo News agency reported.
The drug’s Japanese distributor, Chugai Pharmaceutical, issued a report to the health ministry after the first incident saying a link between taking the drug and the odd behaviour that led to the death cannot be ruled out, the Mainichi said.
The ministry is aware of one of the cases and is warning that taking the drug may lead to abnormal behaviour and accidental death, Kyodo News agency said, citing an unidentified ministry official.
While Tamiflu carries a label in Japan warning of such side effects as “abnormal behaviour” and “hallucinations”, the cases are the country’s first in which strange behaviour linked to the drug has resulted in deaths, the Mainichi said.
Comment was being sought from health ministry officials.
The two people who died had taken Tamiflu to treat cases of influenza and neither exhibited psychological problems before taking the medicine, the Mainichi newspaper reported.
The Japanese government announced plans earlier this month to increase its stockpile of Tamiflu to 250 million capsules, from 150 million, over the next five years in a precautionary measure against a global flu pandemic.
Tamiflu is one of the few drugs believed effective in treating bird flu, which has spread from Asia to Europe. Japan hasn’t reported any infections in humans by the H5N1 virus, which has killed at least 64 people in Asia since December 2003.
Most human cases of bird flu have been traced to direct contact with sick birds, but health officials fear the H5N1 virus could mutate into a form that passes easily between people, possibly triggering a deadly pandemic.
© 2005 AAP
http://www.smh.com.au/news/World/Japan-warns-of-Tamiflu-deaths/2005/11/12/1131578267401.html
The New Dark Age 
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