有關長效ß受體激動劑(Long-Acting Beta Agonists, LABAs)安全性的最新資訊 Latest safety update on Long-Acting Beta Agonists(LABAs)

      美國食物及藥物管理局(USFDA)通知衛生專業人士關於長效ß受體激動劑(Long-Acting Beta Agonists, LABAs)安全性的最新資訊。USFDA在分析臨床研究的結果後, 認為LABAs可能會增加哮喘病人病情惡化的風險﹑導致住院甚至死亡, 基於安全方面的考慮, USFDA更新使用該類藥物的指引。

為確保安全使用此類藥物, 衛生專業人士應注意以下事項:

  • 含單一成份的LABAs只可與其他控制哮喘的藥物併用, 不能單獨使用。
  • 只有服用治療哮喘的藥物後仍不能有效控制症狀的病人才可長期使用LABAs。
  • 儘可能以最短的LABAs使用時間來控制哮喘的症狀, 當哮喘受到控制後, 應停用LABAs。而病人應繼續使用原來的藥物控制病情。
  • 對於有使用類固醇吸入劑的兒童和青少年病人, 如需要增加一種LABA, 應使用含有一種類固醇及一種LABA的複方製劑, 以增加病人服藥的順從性。

USFDA認為, 對於需要加入LABA來控制哮喘病情的病人, 適當地使用LABAs對改善哮喘症狀的效益將大於其潛在風險。

備註:獲准在本澳市場供應長效ß受體激動劑的藥物包括Seretide Accuhaler/Inhaler﹑Serevent Accuhaler/Inhaler﹑Oxis Turbuhaler以及Symbicort Turbuhaler。

     United States Food and Drug Administration(USFDA) notified healthcare professionals about the latest safety update on Long-Acting Beta Agonists(LABAs) Due to safety concerns, FDA is class-labeling changes for all LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in patients as well as death in some patients using LABAs for the treatment of asthma. 

 Healthcare professionals are reminded that to ensure the safe use of these products:

  • Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
  • LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
  • LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
  • Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.

     USFDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs..

Note:The Long-Acting Beta Agonists authorized for distribution in the Macao market include Seretide Accuhaler/Inhaler﹑Serevent Accuhaler/Inhaler﹑Oxis Turbuhaler and Symbicort Turbuhaler.

 

參考資料/References:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201003.htm

https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm

 


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