FDA confirms safety of Tamiflu in children
NEWS IN BRIEF — Posted Dec. 12, 2005
The Food and Drug Administration's Pediatric Advisory Committee found no link between the use of the antiviral oseltamivir (Tamiflu) and the deaths of a dozen children in Japan, according to statement issued in November by Roche Pharmaceuticals, the drug's manufacturer.
"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 William M. Burns, the CEO of the company's pharma division.
The assessment occurred as part of a regularly scheduled review of drugs that have received pediatric exclusivity from the agency. The committee considered data related to reports of adverse psychiatric and skin reactions.
No changes are expected on the label with regard to mental health issues, although the company plans to add information about the possible skin issues.
The drug, currently high profile as a possible tool if pandemic influenza hits, is widely used in Japan during regular flu season. About 33 million people around the world have used the drug, with more than 24 million of those residing in Japan.
In a related action, the scientific committee of the European Medicines Agency, Europe's FDA equivalent, has requested that Roche provide a cumulative safety review of all reports of adverse psychiatric events.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2005/12/12/hlbf1212.htm.