FDA: No link between Tamiflu, Japan deaths
The Star, 19 Nov 2005

WASHINGTON: The US Food and Drug Administration (FDA) concluded on Friday that there was no evidence of a link between Tamiflu and the sudden deaths of 12 children in Japan who were taking the blockbuster flu drug, officials said. 

Roche, the Swiss pharmaceutical giant which markets the drug standing in the front line of defense against a bird flu pandemic, agreed to work on changing the drug's labeling to warn of potential dermatological side-effects. 

But the powerful US medicines regulator found unanimously that there was no “causal link between pediatric deaths and neuropsychiatric adverse events and Tamiflu,” an FDA statement said after a hearing of its pediatric safety panel. 

Roche said it “intends to work with the FDA to change the drug's labeling based on adverse skin events that have occurred in a small number of patients, mostly in Japan.” 

“We welcome the outcome of the FDA advisory committee and look forward to working with the FDA and other health authorities to extend our knowledge of the use of Tamiflu and its safety profile,” said Roche pharma division head William Burns. 

“The positive role of Tamiflu remains unchanged,” he said. 

Reports in Japan have said Tamiflu might have been a factor in several suicides by children aged under 16 who took Tamiflu to treat influenza. 

The FDA has detailed 75 cases of mental and skin disorders worldwide, including 69 in Japan. The European Union's drugs agency has also asked Roche for a safety review into the drug. 

Documents posted on the FDA website attributed increased reports of psychiatric disorders among Japanese children who have taken Tamiflu to a variety of probable causes.