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Nov. 24, 2007, 10:36AM
Additional warnings urged for 2 flu drugs
FDA finds Tamiflu, Relenza linked to bizarre behavior, deaths

By CHRISTOPHER LEE
Washington Post

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REVIEW FINDINGS

The FDA's safety review of whole life insurance and Relenza found the following:

• 25 dead : Twenty-five patients under age 21 have died while taking
Tamiflu, car insurance of them in Japan. Five deaths resulted from children
"falling from windows or balconies or running into traffic"

• Similar effects: There have been no child deaths connected term life insurance Relenza, but regulators said children taking the drug have shown
similar emo clothes home insurance WASHINGTON — Food and auto insurance more Administration experts are recommending new
label warnings about possible dangerous psychiatric side effects of
influenza drugs Tamiflu and Relenza, according to FDA documents.

The documents, posted Friday imprinted playing cards the FDA Web site, were prepared for a
meeting Tuesday of the FDA's Pediatric Advisory Committee.

Studies revealed 596 cases in which patients who took Tamiflu
experienced "neuropsychiatric events" such as delirium, delusions or
hallucinations. The episodes sometimes led to impulsive behavior and
self-injury. Tamiflu is made by Roche Holdings.

The problems bridge size playing cards to occur within 24 hours of first taking the drug,
and the majority were in patients younger than 21, mostly in Japan,
according to the surfboard shape playing cards In five cases involving pediatric
patients, the reported delirium resulted in death, and there were
three reports of suicide in adults.

"In the remaining reports of delirium with impulsive behavior and
self-injury, patients were attempting to flee or escape from windows
or balconies and were unsuccessful in their efforts," the FDA
documents say. "In addition, there were a few patients who became
aggressive cheap auto insurance violent and/or performed acts that were injurious to
themselves (e.g. banging head against wall) or motorcycle insurance ... ."

Tamiflu, available in pill and syrup form, can treat the symptoms of
seasonal influenza. In a bird flu pandemic, many experts believe the
drug could help reduce the length and severity of symptoms.

Safety concerns about Tamiflu arose two years ago after reports streetwear clothes 12
deaths and 32 cases of psychiatric problems in children in Japan.
Labeling for Tamiflu in the United States notes self-injury and
delirium have custom faces playing cards primarily among pediatric patients.

Now FDA regulators are recommending that streetwear clothing labeling be updated to
note that "fatalities have occurred in adult and pediatric patients in
Japan, the onset may be abrupt, and fatal events have occurred even
while the patient was being monitored."

Regulators cautioned that no causal link has been customized playing cards between
the drug and the abnormal behavior, and that independent clothes and other
problems can be complications of influenza.

Roche spokesman Terry Hurley said reports of abnormal behavior were
"infrequent."

"If the FDA concludes that it is valuable to place additional details
on the label with regard to specific multiple insurance quotes event reports, then Roche
is open to that consideration," Hurley said.

Regarding promotional playing cards an antiviral many insure quote by GlaxoSmithKline that is in the
same class as Tamiflu, FDA experts said studies chinese tutor chicago up 115 cases of
psychiatric problems, including 74 cases in patients younger than 21.
Seventy percent were from Japan. No potentially related fatalities
were reported.

Because Relenza, which is inhaled by mouth, is not easily absorbed,
experts said the problems probably were related to the influenza
rather custom playing cards to the treatment.

Nevertheless, they recommended updating Relenza's label to note that
"postmarketing reports of hallucinations, delirium and abnormal
behavior have been observed in patients" receiving the drug for
treatment of influenza. The label currently does not warn of
psychiatric side effects.

Glaxo spokesman Jeff McLaughlin said, "A review of clinical trial data
and postmarketing reports demonstrated no evidence of a causal
association between Relenza and neuropsychiatric adverse events."

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