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Tamiflu caution: Children may act oddly
the Associated Press
Tucson, Arizona | Published: 11.14.2006


WASHINGTON — Doctors and parents should watch for signs of bizarre behavior in children treated with Tamiflu, a flu remedy, federal health officials suggested on Monday, citing an increasing number of such cases from overseas.

Food and Drug Administration officials still don't know if the more than 100 new cases, including three deaths from falls, are linked to the drug or to the flu virus, or to a combination of both. Most of the reported cases involved children.

Still, the FDA's staff suggested updating Tamiflu's label to recommend that all patients, especially children, be closely monitored while on the drug. They 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.

Panel discussion Thursday

The FDA's pediatric advisory committee is to discuss the recommendation Thursday. The FDA isn't required to follow the advice of its outside panels but usually does.
The meeting comes a year after the same panel of outside experts rejected linking Tamiflu to reports of 12 deaths of Japanese children since 2000 and voted against changing the drug's label to suggest any such concern. At that time, however, the committee did recommend that the FDA continue to monitor the drug's safety and return a year later with an update.

Tamiflu could play an important role in an outbreak of bird flu. The drug doesn't prevent flu but can reduce the length and severity of its symptoms.

Most of the 103 new cases of bizarre behavior occurred in Japan, where the number of Tamiflu prescriptions is about 10 times that in the United States.

The new cases occurred during between Aug. 29, 2005, and last July 6. 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 that patients be monitored carefully and the drug stopped if any abnormality is seen.

The proposed changes would bring the U.S. label more in line with the Japanese one. It would warn of abnormal behavior and recommend that patients, especially children, be closely monitored. However, the proposed U.S. version would recommend treatment be stopped only on a doctor's advice.

On the Net: Food and Drug Administration, www.fda.gov