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2006年11月14日，FDA发布达菲警告。达菲是一种口服抗病毒药物，是公认的治疗禽流感病毒H5N1的有效药物之一，也用来治疗季节性流感。它不能预防流感，只是减轻流感症状并使恢复期缩短一至两天。流感症状出现后48小时内服药效果最佳。
FDA共收到103例达菲不良反应报告，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，其中仅一例发生在美国。
FDA警告，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。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，一旦出现异常，应当立即与医生联系。
但FDA同时称，达菲与异常行为之间的关系还不明确。达菲生产厂家罗氏公司称，尽管这些病例与达菲的关系还不能明确，他们将承诺与FDA紧密合作，确保在产品标识上反映出这种情况，以便于卫生保健人员、孩子的父母及监护人能严密观察流感患者有无异常行为迹象。
新西兰的的反应
11月15日，新西兰健康官员证实，新西兰有3例患者服用达菲后发生可疑副作用。其中2例为过敏反应，另1例为恶心及呕吐，与FDA所指出的神经精神症状无关。
作为流感大流行的关键预防措施，新西兰库存855,000个疗程的达菲，足以治疗全国约20%的人口，几千新西兰人自己在家中也有库存。卫生部公共卫生主管Mark Jacobs说，达菲副作用的可能性非常小，不会影响新西兰对流感的预防措施。
http://www.webmd.com/content/article/129/117515.htm
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
More From WebMD
All About Tamiflu
Your Guide to the Flu This Season
Beating the Flu Bug: Is it Possible?
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.
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."
http://www.stuff.co.nz/stuff/0,2106,3861882a7144,00.html
Tamiflu linked to abnormal behaviour
15 November 2006
REBECCA PALMER and agencies
A drug stockpiled by governments worldwide to fight bird flu has been linked to hallucinations and other abnormal behaviour.
New Zealand health officials, who have 855,000 courses of the drug Tamiflu, have confirmed three people here have had suspected adverse reactions to it. But they stress none were neuropsychiatric reactions highlighted in the United States.
The Food and Drug Administration announced yesterday that the drug's label would be updated to warn users should be closely monitored for signs of abnormal behaviour.
But it also said a relationship between the drug and the behaviour had not been established. Severe cases of flu could have sparked the side-effects.
It had received 103 new reports of delirium, hallucinations and other abnormal behaviours in people treated with the anti-viral drug. Most were children from Japan, the biggest user of Tamiflu. At least 12 children taking the drug died in Japan last year.
In New Zealand, Medsafe principal technical specialist Stewart Jessamine said the drug's manufacturer, Roche, had advised that changes would be made to Tamiflu's datasheet in the US and other countries.
Tamiflu is one of a handful of drugs believed to be effective in treating H5N1 bird flu, which has killed about 150 people worldwide since it was first reported in 2003. The drug can also be used to treat seasonal influenza.
New Zealand has stockpiled 855,000 treatment courses of the drug, enough to treat about 20 per cent of the population, as a key defence in a flu pandemic.
Thousands of Kiwis also have their own supplies at home. Tamiflu is available for about $75 a course.
Health Ministry public health director Mark Jacobs said the drug's possible side-effects would not threaten New Zealand's response to a pandemic. "What's being raised is the possibility of something that is very rare."
Medsafe would make labelling changes if needed.
The ministry said there had been three cases of suspected adverse reactions to Tamiflu reported in New Zealand, but none related to the neuropsychiatric conditions highlighted by the FDA. Two were allergic reactions and a third patient complained of nausea and vomiting.
Roche's New Zealand spokesman, Stuart Knight, said the volumes of the drug it supplied for New Zealand children, in a lower dose liquid formation, had been "extremely low".
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