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【drug-news】FDA 公布Tamiflu药物警告
FDA Posts New Tamiflu Warning
About 100 Reports of Self-Injury and Delirium in Patients Taking the Flu Drug By Miranda Hitti
WebMD Medical News Reviewed By Louise Chang, MD
on Tuesday, November 14, 2006
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Nov. 14, 2006 -- The FDA has announced a new warning for the flu drug Tamiflu.
The new warning notes reports of self-injury and delirium in flu patients taking Tamiflu, mainly among children in Japan.
The FDA knows of 103 reported cases -- 95 from Japan, five from the U.S., and three from other countries. Sixty of the 103 cases featured delirium with prominent behavioral disturbance such as panic attack, hallucinations, and convulsions; only one of those cases occurred in the U.S.
It's not known if Tamiflu caused any of those events.
"People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior," states Tamiflu's new warning.
"Patients with influenzainfluenza should be closely monitored for signs of abnormal behavior throughout the treatment period," the warning also notes.
"A healthcare professional should be contacted immediately if the patient taking Tamiflu shows any signs of unusual behavior," states the warning.
The drug company Roche, which makes Tamiflu, sent a letter dated Nov. 13 to health care workers about the new warning. Roche is a WebMD sponsor.
In a Roche news release, the drug company states that "while any relative contribution of Tamiflu to these events is unknown, Roche is committed to working closely with the FDA to ensure that the product label accurately reflects the reports, so that healthcare professionals, as well as parents and guardians, can closely monitor influenza patients for any signs of abnormal behavior."
About Tamiflu
Tamiflu is an oral flu treatment. It does not prevent flu. Instead, it lessens the severity of symptoms and shortens recovery time by one to two days. Tamiflu works best if it is taken within 48 hours of the first symptoms of flu.
Tamiflu was approved in 1999 and has been used by more than 42 million people in over 80 countries, Roche states.
Roche and the FDA continue to monitor Tamiflu safety.
Any adverse events with Tamiflu should be reported to the FDA's MedWatch program by phone at (800) FDA-1088 ((800) 332-1088) or online at www.fda.gov/medwatch.
Adverse events with Tamiflu may also be reported to Roche by phone at (800) 526-6367 or by fax at (800) 532-3931.
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SOURCES: News release, FDA. Crystal Rice, FDA spokeswoman. Roche, "Patient Information, Tamiflu." Roche, "Dear Health Care Professional," Nov. 13, 2006. News release, Roche. WebMD Drug Information from First DataBank: "Tamiflu Oral." 本人已经认领此文. 如在48小时内未能提交译文, 其他战友可自由认领. Nov. 14, 2006 -- The FDA has announced a new warning for the flu drug Tamiflu.
FDA发布达菲警告
The new warning notes reports of self-injury and delirium in flu patients taking Tamiflu, mainly among children in Japan.
FDA在报告中称，有些流感患者服用达菲后出现自伤及谵妄症状，这些患者大部分为日本儿童。
The FDA knows of 103 reported cases -- 95 from Japan, five from the U.S., and three from other countries. Sixty of the 103 cases featured delirium with prominent behavioral disturbance such as panic attack, hallucinations, and convulsions; only one of those cases occurred in the U.S.
It's not known if Tamiflu caused any of those events.
FDA已经得到103例患者的报告，其中95例来自日本，5例来自美国，3例来自其他国家。103例中，有60例表现为谵妄及明显行为障碍如恐慌发作、幻觉及惊厥，只有一例这种病例发生在美国。
还不能肯定是不是达菲导致了这些病例的发生.
"People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior," states Tamiflu's new warning.
"Patients with influenza should be closely monitored for signs of abnormal behavior throughout the treatment period," the warning also notes.
"A healthcare professional should be contacted immediately if the patient taking Tamiflu shows any signs of unusual behavior," states the warning.
警告中说，流感患者尤其是儿童在服用达菲后，短期内出现自伤及混乱的危险性有可能增高，应当严密观察有无异常行为迹象。在整个治疗过程中，应当严密观察服用达菲的患者有无异常行为迹象。一旦出现异常，应当立即与医生联系。
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作者:admin@医学,生命科学 2010-10-12 05:11
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