Thursday, November 16, 2006
Article in the Wall Street Journal -- Data From Tamiflu Maker Point to Flu as Culprit, by Patricia Kowsmann:
The U.S. Food and Drug Administration said Thursday that it received new data from Tamiflu manufacturer Roche Holding AG suggesting that psychiatric problems seen in some patients taking the drug are a result of the flu and not the drug itself.
The agency said it received the new data last week and are still conducting a review. The announcement was made during a FDA panel meeting to discuss the safety review of 16 drugs, including the flu drug, in pediatric patients.
On Tuesday, Tamiflu's label was updated to warn patients of potential abnormal behavior during treatment, including delirium and hallucinations. The change followed a 10-month review by the FDA that found 103 cases of "neuropsychiatric adverse events" in people who were taking the drug. The events included the death of a 14-year-old boy who fell after climbing on his condominium balcony railing.