FDA committee finds no link between Tamiflu and deaths: APAn FDA advisory committee determined today that the anti-flu drug Tamiflu is safe after finding no direct link between the drug and the deaths of 12 Japanese children who had taken it, the Associated Press reported.
"If we ever have a pandemic of avian flu, which is a debatable point, people want to know that they have a drug that will not cause more (harm) than the flu itself," said Robert Nelson, chairman of the FDA's Pediatric Advisory Committee. "There is no evidence that this will."
The committee was reported to have voted unanimously that no change was needed in the label to reflect the deaths of the Japanese children or other adverse affects. The committee did say that information should be added to the label about serious skin reactions.
The FDA is not bound by its advisory committee recommendations, but usually follows them.
Nelson added that the FDA should still be vigilant in going forward despite the finding that there was no reason for concern about the drug at this point. The committee asked the FDA staff to provide an update in about a year on any adverse reactions associated with Tamiflu. A full-report should be made in two years, the committee said.