Additional warnings urged for 2 flu drugs (Tamiflu & Relenza)
Source: Washington Post
WASHINGTON — 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.
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http://www.chron.com/disp/story.mpl/chronicle/5325327.htmlStudies 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 ... ."
http://news.yahoo.com/s/nm/20071123/us_nm/fda_fludrugs_dcFDA staff urges new psychiatric warnings for flu drugs
FDA staff urge warnings for two flu drugs
By Kim Dixon
WASHINGTON (Reuters) - Food and Drug Administration staffers are recommending new warnings about psychiatric events observed in some patients taking Roche Holding AG's Tamiflu and GlaxoSmithKline Plc's Relenza, according to documents released on Friday.
In documents prepared for the meeting next week and posted on the FDA's Web site, agency staff recommended that Tamiflu's label be strengthened to note: "In some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients."
The FDA staff also reviewed Relenza, a drug in the same class as Tamiflu, recommending its label be changed to note "reports of hallucinations, delirium and abnormal behavior" observed in some patients taking the drug.
FDA staff based its recommendations on a review of nearly 600 cases of neuropsychiatric events reported by patients on Tamiflu and 115 cases of such events by patients taking Relenza...
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