New Warnings Urged For Flu Drugs' Labels

[Guest guest]

New Warnings Urged For Flu Drugs' Labels

By Lee

Washington Post Staff Writer

Saturday, November 24, 2007; A02

http://www.washingtonpost.com/wp-dyn/content/article/2007/11/23/AR2007112301

658.html

Food and Drug 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 on the agency's Web site yesterday, 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 tended 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 documents. 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 or violent

and/or performed acts that were injurious to themselves (e.g. banging head

against wall) or others (e.g. child tried to strangle mother). "

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 of 12

deaths and 32 cases of psychiatric problems in children in Japan. Labeling

for Tamiflu in the United States notes that self-injury and delirium have

occurred primarily among pediatric patients.

Now FDA regulators are recommending that U.S. 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 established between the

drug and the abnormal behavior, and that delirium and other problems can

be complications of influenza itself.

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 adverse event reports, then Roche is

open to that consideration, " Hurley said in a statement.

Regarding Relenza, an antiviral drug by GlaxoKline that is in the

same class as Tamiflu, FDA experts said studies turned 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

than 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. "

Schaffner, chairman of the Department of Preventive Medicine at

Vanderbilt University School of Medicine in Nashville, said the proposed

warnings are " prudent and appropriate. "

Schaffner noted that in Japan, where Tamiflu and Relenza are used not just

to treat influenza but to prevent it, some children are on the drugs for

as long as seven weeks. In the United States, the drugs primarily are used

to treat illness, and children typically are on them for five days or

less.

" We still don't know whether there is a causal relationship between the

exposure to these events and the drugs, " he said, " but we use these drugs

differently than they do in Japan. "

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