Deaths Among Roche Tamiflu Users Get U.S. FDA Review (Update2)

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Nov. 17 (Bloomberg) -- U.S. regulators will review the deaths of 12 Japanese children who took Roche Holding AG's Tamiflu influenza medicine, being stockpiled worldwide as the best likely treatment for bird flu.
Four were due to ``sudden death, an unusual phenomenon in otherwise healthy'' people 16 and under, the Food and Drug Administration said in a report posted today on its Web site. Other causes were cardio-respiratory arrest, suicide, pneumonia and asphyxiation. In addition, Tamiflu users reported hallucinations and convulsions, the FDA said.
``This may mean that there are some parents and patients out there that will decline to use'' Tamiflu for seasonal outbreaks of less-lethal flu strains, said Bob Pooler, analyst at Lombard Odier Darier Hentsch in Zurich, in an interview today. ``In pandemic use, it's the only choice, except maybe for Glaxo's Relenza, that governments have.''
The FDA panel is reviewing Tamiflu risks tomorrow at a routine meeting required by law. Demand for Tamiflu has surged with the threat of a global epidemic of the avian influenza that has killed at least 67 people in Asia since 2004. Third-quarter sales more than doubled to 279 million Swiss francs ($211 million). About 50 countries including the U.S. and Japan placed orders of more than $1.4 billion.
Shares of Basel, Switzerland-based Roche fell 3.6 Swiss francs, or 1.9 percent, to 188.5 Swiss francs as of 5:30 p.m. in Zurich. Shares of Roche's partner Gilead Sciences Inc. fell $1.53, or 2.8 percent, to $54.10 at 12:03 p.m. New York time after trading as low as $51.68 in Nasdaq Stock Market composite trading.
Tamiflu, Bird Flu
Tamiflu, which is approved for the treatment and prevention of influenza, has been shown to fight the H5N1 avian and human virus strains in test-tube and animal trials. There is also anecdotal evidence that the pill works in humans. London-based GlaxoSmithKline Plc's inhaled Relenza has been shown to work in mouse tests.
Roche spokeswoman Martina Rupp couldn't immediately comment on today's FDA report.
Roche acquired the rights to Tamiflu in 1996 from Foster City, California-based Gilead, the drug's inventor. Roche agreed yesterday to pay $62.5 million to Gilead to end a dispute over rights to the product.
The FDA is studying reports of injuries among Tamiflu users as part of a review intended to gather more research on how medicines work in children. The FDA panel tomorrow also will look at reports related to other drugs such as Pfizer Inc.'s Diflucan antifungal and the withdrawn Merck & Co. Vioxx painkiller, according to a posting on the agency's Web site.
Focus on Japan
``Deaths from influenza are uncommon among both children with and without high-risk conditions, but do occur,'' the FDA report said. ``Attribution of causality for the reports of sudden death and cardio-pulmonary arrest are extremely difficult to interpret because there is limited information leading up to the event.''
More than 90 percent of reports of serious complications in pediatric Tamiflu users stem from Japan, the FDA said in its report. The FDA is looking into whether Japanese people may take herbal medications that would predispose them to complications and whether genetic difference might be a factor.
The FDA has proposed monitoring complications in Tamiflu users and bringing the findings back to its advisory committee in the next two years, according to a document posted on its Web site. The FDA also asked the committee whether additional information is needed on serious skin reactions in people using the drug.
That approach suggests the FDA still considers Tamiflu safe, said Ira Loss, an analyst with Washington Analysis who has been following the FDA for more than two decades, in a telephone interview today.
``It's hard for me to imagine that the FDA is too worried if they are going to wait for two years,'' Loss said.