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FDA Can't Link Tamiflu to Deaths

Updated from 10:16 a.m. EST

The Food and Drug Administration said it doesn't see a causal relationship between Gilead's (GILD) flu drug Tamiflu and a handful of deaths among young people in Japan, based on the information it currently has.

However, the members of the agency's pediatric advisory committee did recommend that the drug's labeling be revised to include the risk of a severe skin reaction, which occurred in a number of patients using Tamiflu.

The FDA reviewed information on 12 deaths, all in Japan, including one suicide, four sudden deaths, four cases of cardiac arrest and incidents of pneumonia, asphyxiation and pancreatitis.

Tamiflu, which is marketed by Switzerland's Roche, has been getting considerable media coverage lately because it's viewed as one of the best options to fight a possible pandemic bird flu. Worries about avian flu have been on the rise because the disease has gone from birds to humans in at least five Asian nations. Japan isn't among them.

On Friday, the FDA also reviewed seven other products. The review had been planned and wasn't held specifically to address the deaths. The agency is required to review the adverse-event reports received during the first year after a drug has been granted pediatric clearance, which applies to Tamiflu.

Regarding the deaths in Japan, the FDA said in many cases, "a relationship to Tamiflu was difficult to assess because of the use of other medications, presence of other medical conditions and/or lack of adequate detail in the reports."

Episodes of abnormal behavior, hallucinations and convulsions have also been seen in children.

The FDA said a review of the available data "suggests that the increased reports of neuropsychiatric events in Japanese children are most likely related to an increased awareness of influenza-associated encephalopathy, increased access to Tamiflu in that population and a coincident period of intensive monitoring adverse events."

Several of the documented neuropsychiatric occurrences happened in children who were taking Tamiflu and herbal medications at the same time.

The FDA said it's also seeking information on possible differences in drug dosing in Japan and whether Tamiflu actually reacts differently in Japanese patients.

The now-withdrawn painkiller Vioxx, the antifungal Diflucan and the migraine medication Imitrex are among the other drugs the FDA was reviewing.

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