特敏福會帶黎咩野問題．．．

特敏福 Tamiflu (oseltamivir)

Common adverse drug reactions (ADRs) associated with oseltamivir therapy include: nausea, vomiting, diarrhea, abdominal pain, and headache. Rare ADRs include: hepatitis and elevated liver enzymes, rash, allergic reactions including anaphylaxis, and Stevens-Johnson syndrome. (Rossi, 2006)

Various other ADRs have been reported in postmarketing surveillance including: toxic epidermal necrolysis, cardiac arrhythmia, seizure, confusion, aggravation of diabetes, and haemorrhagic colitis

FDA Probes Tamiflu's Effect on Kids

Is Tamiflu safe for kids? With a potential bird flu pandemic in the making, the Food and Drug Administration (FDA) is looking for answers, in the wake of reports that 12 children died in Japan after being trested with Tamiflu, a powerful antiviral drug.

Tamiflu is currently approved for treatment of uncomplicated influenza A and B in patients 1 year of age or older and is the leading candidate for widespread use if a bird flu pandemic breaks out. While there are no vaccines against bird flu, health officials believe Tamiflu might be effective in helping victims recover from it.

The stepped-up safety review is mandated by the Best Pharmaceuticals For Children Act because of reports of adverse events in children 16 years of age or younger, including unusual neurologic or psychiatric events such as delirium, hallucinations, confusion, abnormal behavior, convulsions, and encephalitis.

These events were reported almost entirely in children from Japan who received Tamiflu according to Japanese treatment.

The review identified a total of 12 deaths in pediatric patients since Tamiflu's approval. All of the pediatric deaths were reported in Japanese children. In many of these cases, FDA said a relationship to Tamiflu was difficult to assess because of the use of other medications, presence of other medical conditions, and/or lack of adequate detail in the reports.

?Initially, it was not clear why the neuropsychiatric adverse events and deaths were reported almost entirely in Japanese children. The FDA receives adverse event reports from all over the world and usually adverse events are roughly the same from different reporting countries," the agency said. "The reports of death and neuropsychiatric events associated with Tamiflu, almost entirely from Japan, was unusual enough to prompt further evaluation."

The FDA said it has requested additional information from both Hoffman-La Roche, the pharmaceutical company which produces Tamiflu, and the Japanese Ministry of Health, Labor, and Welfare. FDA said it is evaluating several possible explanations for the adverse events.

?The Pediatric Advisory Committee discussion is not directly addressing any issues related to pandemic flu preparations,? the FDA said in a statement. ?Indirectly, a better understanding of Tamiflu safety in children will be useful should a pandemic occur and there is widespread use of Tamiflu.?

不良反應
在羅氏提交美國聯邦食品和藥品管理局的申報材料中指出，奧司他韋主要的不良反應顯示為消化道的不適，包括噁心、嘔吐、腹瀉、腹痛等，其次是呼吸系統的不良反應，包括支氣管炎、咳嗽等，此外還有中樞神經系統的不良反應，如眩暈、頭痛、失眠、疲勞等。

在2004年1月，FDA還發出對於奧司他韋的消費警訊，聲稱由於1歲以內幼兒血腦屏障發育不完全，奧司他韋應用於幼兒可能造成腦內藥物濃度過高，形成潛在的安全問題。

2005年有日本媒體報導日本青少年服用奧斯他韋後自殺並有精神異常反應，此後日本先後報導數十例此類不良反應，此後世界各地媒體紛紛轉載報導，引起公眾關注。2005年11月FDA就這一反應作出報告，認為沒有證據證明奧斯他韋可以導致精神異常，日本的不良反應病例系大眾媒體報導後經心理暗示作用引起的群體性臆症。