Roche and GlaxoSmithKline, makers of Tamiflu and Relenza, respectively, are facing pressure to accept a recommendation by the United State Food and Drug Administration panel to put stronger warning labels on their flu treatments. Tamiflu, known generally as oseltamivir, is a pill, while Relenza, generically zanamivir, is inhaled, and the drugs are the two most frequently used prescription medications to treat the flu. The issue of the adequacy of the warnings was raised by the FDA after reports of a dozen deaths of children in Japan who were taking Tamiflu. The FDA wants the companies, particularly Roche, to add a caution urging close monitoring of patients for abnormal behavior such as delirium or self-injury. Recently, Roche has indicated that it has accepted the FDA recommendation.
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Tamiflu’s label already mentions reports of delirium and self-injury, but some of the FDA’s experts suggested that the language should mention that several patients have died as a result of these abnormal behaviors. Relenza’s label does not currently contain any information relating to adverse psychiatric events, however, Relenza does not penetrate the central nervous system easily and there is no substantial evidence that it has caused problems with recurrent use.
Nearly 600 cases of psychiatric problems have been reported in Tamiflu patients, with 75 percent of them coming from Japan. Five children there have died after falling from windows or balconies or running into traffic, according to the FDA. There have also been 55 reports in the United States; 22 of these reports included symptoms such as convulsions, delirium or delusions. Many in the U.S. relayed stories similar to those in Japan, explaining that the children were trying to flee or escape through windows, while others became violent.
"Although there is still uncertainty about the cause of the reported abnormal behavior in patients," the FDA posted on its website, it is prudent to add information to the labeling, and they will "continue to monitor" the drugs.
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Tamiflu and Relenza sales have netted the companies over $1 billion in the first half of 2007, boosted by government stockpiling of the drug in the event the bird flu virus mutates into a form that can be easily transmitted among humans.
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