Regulatory agency asserts Tamiflu safe

Thursday, November 17th 2005, 1:21 pm

By: News On 6

WASHINGTON _ The antiflu drug Tamiflu is safe, federal health advisers said Friday, after finding no direct link between the drug and the deaths of 12 Japanese children who had taken it.

``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 Dr. Robert Nelson, chairman of the Food and Drug Administration's Pediatric Advisory Committee.

The committee reviewed Tamiflu as part of a routine safety check of drugs whose original uses had been extended to cover children.

Interest was raised, however, because the drug is key in the arsenal of treatments for pandemics caused by bird flu or another superflu strain.

The committee voted unanimously that no change was needed in the label to reflect the deaths of the Japanese children or other adverse affects. But it 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 said the FDA should still be vigilant in going forward despite the finding that there was 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.

``Influenza is a serious disease. Kids die of influenza, both in Japan and the United States, and if you give a drug to people who are at risk of dying, there will be people who die who got the drug,'' Nelson said. ``There is no signal the drug is doing it as opposed to the disease.''