FDA Disagrees With Study Warning Against Tamiflu Use in Kids

Children should not routinely be given flu drugs like Tamiflu since there is no clear evidence they prevent complications and potentially harmful side effects may outweigh any benefits, British researchers said on Monday.

"While morbidity and mortality in the current pandemic remain low, a more conservative strategy might be considered prudent, given the limited data, side effects such as vomiting, and the potential for developing resistant strains of influenza," they said.

Governments around the world have built up stockpiles of Roche's Tamiflu and GlaxoSmithKline's Relenza to deal with the current H1N1 swine flu pandemic.

However, the U.S. Food and Drug Administration said Tamiflu is safe for children 1-year-old and older.

"That's what the FDA has approved the drug for," Patrica El-Hinnawy, a press officer at the FDA said Monday morning.

In Britain, hundreds of thousands of doses of Tamiflu have been handed out to people with the disease, of whom around half are children.

But Matthew Thompson from the University of Oxford and colleagues reported in the British Medical Journal that while antivirals shortened the duration of flu in children by around a day, they didn't reduce asthma flare-ups or the likelihood of children needing antibiotics.

Tamiflu was also linked to an increased risk of vomiting, which can be serious in children.

The analysis was based on a systematic review of seven previous clinical studies looking at use of Tamiflu and Relenza in seasonal flu outbreaks in children aged 1 to 12 years.

Thompson told reporters there was no reason to think the conclusions would not also apply to the current relatively mild outbreak of swine flu.

Reuters contributed to this report.