FDA Advisory Committee Affirms Safety of Tamiflu in Children

NUTLEY, N.J. -- The Pediatric Advisory Committee of the Food and Drug Administration (FDA) has confirmed the safety of Tamiflu (oseltamivir phosphate) in children following a scheduled comprehensive review of data about the use of Tamiflu in children. According to Dr. Robert M. Nelson, chairman of the committee, there is "no concern at all" that Tamiflu played a role in the reported deaths of children with influenza in Japan. Nelson is an associate professor in the department of anesthesia and critical care at The Children's Hospital of Philadelphia.

The FDA indicated that it intends to continue normal monitoring of the safety of Tamiflu for use in children, but found no basis for changing the labeling of the product for neuropsychiatric issues. Roche 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. The FDA said it would report back to the committee in two years.

"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. The positive role of Tamiflu remains unchanged," commented William M. Burns, CEO Roche Pharma Division.

The meeting of the Pediatric Advisory Committee on Nov. 18, 2005 was a scheduled one at which adverse events for eight medicines used in children were reviewed. Tamiflu was among the drugs reviewed because it was granted pediatric exclusivity in March 2004.  Pediatric exclusivity is granted as an incentive to industry to study the use of medicines in children.

Source:  Roche