FDA examines pediatric effect of Roche’s Tamiflu today
The FDA is studying the deaths of 12 Japanese children who took Roche's Tamiflu (oseltamivir) at a meeting in Gaithersburg, Md., today.
The Tamiflu discussion is part of a routine review involving eight drugs by the Pediatric Advisory Committee, including Merck's Vioxx (rofecoxib), Pfizer's Diflucan (fluconazole) and Camptosar (irinotecan), GlaxoSmithKline's Imitrex (sumatriptan), Shire's Agrylin (anagrelide), Watson's Ferrlecit (sodium ferric gluconate complex) and Bristol-Myers Squibb's Paraplatin (carboplatin). An analysis from the FDA's adverse-events database revealed 32 cases spanning the first year since Tamiflu gained marketing exclusivity in children; 31 occurred in Japan. Deaths were accompanied by reports of serious skin reactions and neuropsychiatric events, all in children 16 years of age or younger. Roche maintains, in documents submitted to the committee, that the majority of the Japanese children had other conditions, including high fever or influenza, and that there is "no trend leading to concern about Tamiflu use in children." Japan uses most of the world's supply of Tamiflu distributed for seasonal
Worldwide, 13 million young people have been treated with Tamiflu since 1999, 11.6 million of them in Japan. A statement on the FDA Web site before the meeting said, while the high incidence of reports in the country is "unusual," "we cannot conclude that there is a causal relationship between Tamiflu and the reported pediatric deaths." FDA advisory committee members said they would not propose an update to the drug's labeling to address these events. According to Internet and newspaper reports today, committee members were however expected to propose the monitoring of adverse events related to Tamiflu for the next two years and were also expected to propose the addition of warnings to the drug's label to discuss serious skin reactions caused by an allergy to the drug.