藥物警訊（藥師週刊 第1703期）

Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure
AUDIENCE: Pediatrics, Family Practice
FDA updated the Warnings and Precautions sections of the Prescribing Information for Afluria to inform healthcare professionals that the Afluria vaccine has been associated with an increased incidence of fever and febrile seizure among young children reported in Australia, mainly among those less than 5 years of age.
BACKGROUND:? FDA announced the approved vaccines for the 2010-2011 influenza season in the United States. The brand names and manufacturers for the upcoming season’s vaccines are: Afluria, CSL Limited; Agriflu, Novartis Vaccines and Diagnostics; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone and Fluzone High-Dose, Sanofi Pasteur Inc.
The available data suggest that the increased rates of fever and febrile seizure are only associated with the Southern Hemisphere formulation of CSL's vaccine. The available data regarding the safety of other influenza vaccines for children used in the Southern Hemisphere do not suggest an increased rate of fever or febrile seizure. FDA is requiring CSL Limited to conduct a study of Afluria in children to obtain additional information regarding the febrile events that were seen in the Southern Hemisphere. CSL Limited will not be supplying the United States with the 0.25 milliliter single-dose, prefilled syringes, which are used in very young children. The 0.5 milliliter single-dose, prefilled syringes and 5 milliliter multi-dose vials will be distributed.
RECOMMENDATION: Vaccines for the 2010-2011 influenza season are approved by FDA for the prevention of influenza in children, adolescents, and adults, including the elderly. There are several vaccines approved by FDA available in both nasal spray and injectable (“shot”) forms. Because the influenza viruses that cause people to get sick can change, each year's vaccine may be different from the previous year.?Therefore, it is important to get the influenza vaccine every year.
Various investigations into the cause(s) of the febrile seizures seen with Afluria vaccine are still ongoing. FDA is collaborating with Australia's regulatory authority, other international regulatory counterparts, and CSL to obtain additional information, stay apprised and take part in the investigations. FDA, in collaboration with CDC, will closely monitor the continued safety of all influenza vaccines.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the Vaccine Adverse Events Reporting System, a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention and the Food and Drug Administration.
Read the MedWatch safety alert, including links to FDA Q&As, News Release, Product Page, and the Package Insert, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220764.htm
FDA變更Afluria藥品仿單中警告及注意事項等資訊，告知醫護人員於澳洲的報告中，Afluria使用於5歲以下的孩童，會增加發燒及發熱型癲癇的發生率。
Afluria為FDA宣佈核准用於美國2010至2011年流感的疫苗之一，根據現有資料，CLS公司的Afluria是唯一用於南半球的孩童會增加發燒及發熱型癲癇發生率的流感疫苗，而其他流感疫苗則不會，FDA要求CLS公司著手研究以取得更多的資訊，CLS公司將不會提供0.25 mL單一劑量，預先充填的注射器給全美年紀很小的孩童，改為提供0.5 mL單一劑量，預先充填的注射器及5 mL多劑量的小瓶裝品項。
2010至2011年的流感疫苗經FDA核准用於預防小孩、青少年、成人以及老人感染流感病毒，此外，FDA也核准了其他鼻噴劑型及注射劑型的疫苗，因為造成致病的流感病毒可能改變，所以每年的疫苗不一定與往年相同，因此，每年接種流感疫苗很重要。
有許多關於Afluria造成發熱型癲癇原因的研究仍在進行中，FDA正與澳洲管理協會、其他國際的管理對等機構及CLS公司合作以取得更多的資訊、持續通報及參與研究，且FDA將與CDC合作，密切監測所有流感疫苗的後續安全性報告。

相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220764.htm
[Posted 07/30/2010]

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部