FDA Probes Tamiflu Deaths

U.S. and E.U. authorities investigate reports of suicides of Japanese teenagers who took flu treatment.
November 18, 2005

The U.S. Food and Drug Administration said it is reviewing safety reports on Tamiflu on Friday after reports of 12 deaths in Japan among children under the age of 16 taking the flu treatment.



The fatalities included four sudden deaths, which the FDA said were unusual, and two reports of teenagers who committed suicide, including one who ran into traffic and was hit by a truck, and another who fell from the ninth floor of his apartment building.



The FDA’s Pediatric Advisory Committee is receiving safety reports on Tamiflu, along with seven other drugs, including Vioxx and Imitrex, as part of a regularly scheduled review. However, Tamiflu is receiving special attention because it is believed to be the only available treatment for avian flu.



“The review of the adverse event reports for Tamiflu will discuss pediatric deaths, serious skin reactions, and neuropsychiatric events,” said a Q&A statement posted on the FDA web site. “These events were reported almost entirely in children from Japan.”


No Hard Evidence

The FDA stated that it has not found any evidence that Tamiflu is responsible for the deaths. When Tamiflu was studied in clinical trials as treatment for children with flu, the children taking Tamiflu experienced similar side effects as the children not taking Tamiflu.



The FDA also did not identify serious side effects in Tamiflu. The most common side effects were nausea and vomiting.



The FDA may require that Tamiflu maker Roche add a label warning of skin rashes. Basel, Switzerland-based Roche and Tamiflu developer Gilead Sciences, based in Foster City, California, reached a legal settlement in their royalty dispute on Wednesday (see Roche, Gilead End Tamiflu Feud).



However, European regulators also asked Roche late Thursday for safety data. The Committee for Medicinal Products for Human Use, a scientific committee of the European Medicines Agency, has requested the information.



Roche defended the treatment, saying that only one out of a million children who had used the treatment had died, and the drug would prevent millions of flu deaths.



Roche also contended that 32 million people globally have used Tamiflu, of whom 89 died and 130 experienced neuropsychiatric events. The two adolescents who committed suicide were said to have shown signs of abnormal behavior.



Why Japan?

The FDA is especially interested in finding out why Tamiflu is causing the deaths in Japan.



“Initially, it was not clear why the neuropsychiatric adverse events and deaths were reported almost entirely in Japanese children,” said the FDA. “The FDA receives adverse event reports from all over the world and usually adverse events are roughly the same from different reporting countries.



“The reports of death and neuropsychiatric events associated with Tamiflu, almost entirely from Japan, were unusual enough to prompt further evaluation,” added the FDA.

The FDA has requested additional information from both Hoffman-La Roche, the Nutley, New Jersey-based U.S. headquarters of the Swiss pharmaceutical company, and the Japanese Ministry of Health, Labor, and Welfare.



The FDA is also evaluating other possible explanations for the neuropsychiatric adverse events. The deaths may be related to societal pressures. Teenage suicide rates are high in Japan, where some teenagers meet online to discuss killing themselves and make suicide pacts.



Nevertheless, the link to Tamiflu is a concern, especially as Roche increases Tamiflu production to keep up with demand as fears of an avian flu pandemic keep growing.

http://www.redherring.com/Article.aspx?a=14546&hed=FDA+Probes+Tamiflu+Deaths&...