Tamiflu may get 'psychotic behavior' warning for Children
Pastor Dale Morgan
Tamiflu may get 'psychotic behavior' warning for Children*
Posted 11/13/2006 2:51 PM ET
WASHINGTON (AP) — Doctors and parents should watch for signs of bizarre
or psychotic behavior in children treated with the flu drug Tamiflu,
federal health officials suggested Monday in 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 a combination of both. Most of the reported
cases involved children.
Still, FDA 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.
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. An FDA spokeswoman did not immediately return a
call seeking comment.
The meeting comes a 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 time, however, the committee did recommend that
the FDA continue to monitor the drug's safety and return a year later
with an update.
The panel's decision after reviewing the new update is likely to be
closely watched, since 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 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 new 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.
Even though severe cases of the flu can spark those conditions, the
number and nature of the cases — along with comments from doctors who
believe the abnormal behavior was associated with the drug — keep the
FDA from ruling out Tamiflu as the cause, according to agency documents.
For that reason, the proposed changes would bring the U.S. label more in
line with the Japanese one, and 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.
FDA staff called 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.
Tamiflu is made by the Swiss pharmaceutical company Roche Holding AG. A
Roche spokesman did not immediately return messages seeking comment.
Previously, Roche has cited studies from the United States and Canada
that show the death incidence rate of influenza patients who took
Tamiflu was far below those who did not.
Tamiflu is one of the few drugs believed effective in treating bird flu,
which health officials fear could spark a pandemic should it mutate into
a form easily passed from human to human.