FDA on label precautions on flu drugs for kids

Government health regulators recommended that the label precautions neurological problems in children who are due for a flu medicine from Roche and GlaxoSmithKline.

The Food and Drug Administration Friday examining the safety of Tamiflu by Roche and Glaxo of relenza. FDA’s panel of experts from outside the government before the labeling at its meeting on Tuesday. The FDA is not obligated to follow the instructions of experts from outside, even if it is not the normal case.

The FDA has to consider how the safety of Tamiflu in 2005 after receipt of reports of child learns neurological problems, including hallucinations and convulsions.

Twenty-five patients under 21 years were killed, with the drug, most of them in Japan. Five people died, the children in the windows or balconies or walk in traffic. ”

More than 48 million patients, including 21 million children who have taken Tamiflu, since he was in 1999. The drug, currently in the capsule and liquid form, had a turnover of $ 2.4 billion last year.