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Injured by Tamiflu

On November 13, 2006, the FDA alerted doctors and parents too watch for signs of bizarre behavior in children treated with Tamiflu. This warning was based upon federal health officials noticing an increasing number of such cases from overseas. Tamiflu (generic: oseltamivir phosphate) is prescribed to treat the flu is manufactured by Roche Laboratories, Inc. and was approved for use by the FDA on October 27, 1999.

Food and Drug Administration (FDA) representatives to date still don't know if the more than 100 new cases, which include three deaths from falls, are associated to the drug or to the flu virus or a combination of both. The majority of the reported cases include children. FDA officials have suggested and are meeting on November 16, 2006 to discuss updating Tamiflu's label to recommend that all patients, particularly children, be closely monitored while on the drug. The FDA also acknowledged that stopping treatment with Tamiflu could actually harm influenza patients if the virus is the cause of delirium, hallucinations and other abnormal behavior, such as aggression and suicidal thoughts.

The new meeting comes one year after the same panel of outside experts rejected linking Tamiflu to reports of 12 deaths in Japanese children since 2000 and voted against changing the drug's label to suggest any such concern. At that point in time, the committee did recommend that the FDA continue to monitor the drug's safety and return a year later with an update. Nearly all of the 103 new cases of bizarre behavior are from Japan, where the number of Tamiflu prescriptions is about 10 times that in the United States, with more than twice the population.

The latest cases occurred during a 10-month period, between Aug. 29, 2005, and July 6, 2006. The tally marks a sharp increase to the 126 similar cases logged over the more than five years between the drug's approval in 1999 and August 2005, the FDA said. The Japanese Tamiflu label now warns that disturbances in consciousness, abnormal behavior, delirium, hallucination, delusion and convulsion may occur. It also recommends patients be carefully monitored and the drug stopped if any abnormality is observed.

The FDA calls the proposed changes "prudent," since U.S. Tamiflu use could jump to Japanese levels. The current U.S. label mentions only "seizure and confusion" seen in some patients.

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