Tamiflu Use Unrelated to Deaths, FDA Says

FDA's Pediatric Advisory Committee decided there is insufficient evidence linking the antiviral drug Tamiflu (oseltamivir phosphate) to the deaths of 12 Japanese children or to hallucinations and other symptoms suffered by some of the children given Tamiflu. Tamiflu, made by Hoffmann-La Roche, is used to reduce the duration and severity of influenza and is the primary drug that would be given in the event of a flu pandemic. Between 2001 and 2005, it was prescribed to 11.6 million children in Japan as compared with just 872,000 in the U.S. The agency's staff is recommending, however, that the drug's label be changed to indicate that Tamiflu may cause serious skin reactions. A small number of patients, mostly in Japan, have experienced skin reactions after taking Tamiflu. The advisory committee reviewed Tamiflu along with seven other drugs whose original adult uses were extended to children. FDA intends to continue normal monitoring of the safety of Tamiflu and will report back to the committee in two years. “We welcome the outcome of the FDA advisory committee and look forward to working with FDA and other health authorities to extend our knowledge of the use of Tamiflu and its safety profile,” says William M. Burns, CEO of Roche's pharma division.