Federal drug regulators said this week there was insufficient evidence to tie the flu drug Tamiflu to the deaths of 12 Japanese children or to hallucinations, encephalitis, and other symptoms suffered by some Japanese patients.
Food and Drug Administration staff said they don't think it's necessary to update the drug's labeling to reflect those deaths or possible adverse effects. But the staff is recommending adding information to the label about serious skin reactions to Tamiflu.
Unlike other ailments reported in patients who took Tamiflu, the skin reactions don't appear to be related to the influenza the patients were being treated for, officials said.