FDA Mulls Tougher Warning Label on Kids' ... (en any such cases reported in the United...)

FDA Mulls Tougher Warning Label on Kids' Flu Drugs

Date:11/27/2007

en any such cases reported in the United States, according to the FDA.

The FDA began reviewing Tamiflu in 2005, and, since November 2006, the drug's label has had a warning focused on self-injury and delirium. The label also advises that patients be monitored during treatment. In March of this year, the Japanese Ministry of Health, Labor, and Welfare limited Tamiflu use in patients 10 to 19 years of age.

In their safety review, experts at the FDA advised the committee to amend the label warning to note that there were deaths in Japan related to Tamiflu and to strengthen monitoring for patients taking the drug.

However, "A restriction on the use of oseltamivir in the U.S. does not seem warranted at this time based on the post-marketing data and the still unanswered question about whether these events are due to oseltamivir, influenza/fever, or a combination of the two," the agency safety review said.

The maker of Tamiflu, Hoffmann-La Roche Inc., of Nutley, N.J., noted that Tamiflu is used some six times more in Japan than in the United States. Moreover, whether the bizarre behavior observed is a result of the drug or the flu itself remains unclear, the company said.

The company sees no need for a label change. "Thus, the information on neuropsychiatric events currently within the Precautions section of the Tamiflu [label] continues to be an accurate assessment of all available updated and expanded data," it said in a report to the FDA.

Siegel believe a new warning is appropriate. "The idea that there have been 596 neuropsychiatric events is a reason for the FDA to put a strong warning on the label," he said.

Millions of people have taken the drug, so the odds that any one patient would have these reactions are very low, Siegel said. "People in high-risk groups achieve more benefit from the drug [against the flu] than they accrue risk for neuropsychiatric events," he said.

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