By SABIN RUSSELL
San Francisco Chronicle
November 16, 2005
The drug is Tamiflu, also known as oseltamivir, which will become the world's first line of defense if the avian influenza now spreading among migrating birds from Asia to Eastern Europe ever mutates into a form that transmits readily to people.
In February 2004, according to an online edition of Japan Times, a 17-year-old high school boy under treatment with Tamiflu died after he jumped in front of a truck.
A year later, a 14-year-old junior high student, also taking the drug for influenza, jumped to his death from the ninth floor of his condominium.
The newspaper also reported that Japan's Pharmaceutical and Medical Devices Agency - the Japanese equivalent of the Food and Drug Administration - has logged 64 cases of psychological disorders linked to Tamiflu.
Terry Hurley, a spokesman for Tamiflu maker Roche, said the company was aware of the two apparent suicides and had informed "regulatory authorities around the world."
In the case of the first teenage death, Hurley said the boy had taken Tamiflu after first being treated with amantadine, an older anti-flu drug that is well-known for central nervous system side effects. In the second case, he said there was insufficient information to determine whether the boy's fall was the result of accident or suicide.
Both tragedies, he indicated, could have been triggered by the illness itself.
"Neuropsychiatric disturbances, such as those seen in the two cases, are known complications of influenza and its associated high fever," he said.
Japan's Tamiflu label carries a more extensive list of side effects than that required in the United States. Adverse events reported on the Japanese label include "impaired consciousness, abnormal behaviors, hallucination and other psychological and neurological symptoms," Hurley said.
Tamiflu's U.S. label lists a range of side effects, but the most common are nausea and vomiting. Of the others noted in the clinical trial of the drug, only vertigo, insomnia and bronchitis occurred at a higher rate than those taking a placebo for comparison.
Hurley said the company could not comment on the unspecified psychological disorders reported in Japan, but that conditions such as convulsions, tremor, lethargy and excitability are all consistent with influenza and dehydration.
Dr. Roger Baxter, director of flu programs for Kaiser Permanente, said he was not aware of psychological side effects in that health system's experience treating patients with Tamiflu. However, he said the central nervous system side effects of two older flu drugs, amantadine and rimantadine, are very common and can include confusion and occasional seizures.
Japan's experience with Tamiflu is noteworthy because it is the only country where Roche has had marked success in selling it as a treatment for ordinary influenza. At a meeting at Roche headquarters in Basel last week, pharmacy chief executive William Burns said Japan was the one government that embraced Tamiflu treatment for seasonal influenza as a public health issue, and that consequently that country provides "the best clinical experience and exposure in the regular winter season."
Japan's enthusiasm for Tamiflu has not diminished. The country has started the last few influenza seasons with enough of the drug on hand to treat 10 percent of its population, and it has ordered enough for a stockpile to treat 25 million in the event of a bird flu-sparked pandemic.
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