藥物警訊

Tramadol: Drug Safety Communication - FDA Evaluating Risks of Using in Children Aged 17 and Younger

AUDIENCE: Health Professionals

ISSUE: FDA is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. FDA is evaluating all available information and will communicate final conclusions and recommendations to the public when the review is complete.

Tramadol is not FDA-approved for use in children; however, data show it is being used “off-label” in the pediatric population. Health care professionals should be aware of this and consider prescribing alternative FDA-approved pain medicines for children.

BACKGROUND: In the body, tramadol is converted in the liver to the active form of the opioid, called O-desmethyltramadol. Some people have genetic variations that cause tramadol to be converted to the active form of the opioid faster and more completely than usual. These people, called ultra-rapid metabolizers, are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death. Recently, a 5-year-old child in France experienced severely slowed and difficult breathing requiring emergency intervention and hospitalization after taking a single prescribed dose of tramadol oral solution for pain relief following surgery to remove his tonsils and adenoids. The child was later found to be an ultra-rapid metabolizer and had high levels of O-desmethyltramadol in his body.

RECOMMENDATION: Parents and caregivers of children taking tramadol who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness should stop tramadol and seek medical attention immediately by taking their child to the emergency room or calling 911. Parents and caregivers should talk with their child’s health care professional if they have any questions or concerns about tramadol or other pain medicines their child is taking.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

止痛藥tramadol可能引起罕見但嚴重的呼吸抑制或呼吸困難，尤其是接受扁桃腺或腺體切除術後兒童發生風險較大。因此對於此藥是否適用於17歲以下兒童，美國FDA正進行評估調查中，未來會公告最終結論及建議。

臨床上有時會使用tramadol給予小兒族群止痛，但此用法並未經過FDA核准，屬「非適應症使用」(off-label use)。醫療人員在處方兒童止痛藥時應以有FDA核准可使用的藥品為優先。

Tramadol在體內經由肝臟轉換成活性opioid成分O-desmethyltramadol，有些人因基因變異性，能快速且完整的代謝tramadol，其血中opioid濃度容易比正常值高出許多。高濃度opioid可能引起呼吸困難，也可能致命。近期法國曾接獲一名5歲兒童在接受扁桃腺及腺體切除術後使用tramadol止痛而發生嚴重吸呼抑制及呼吸困難需緊急送急診處置之案例。此名兒童後續發現為具有基因變異性，可快速代謝tramadol，並且也發現其體內具有高濃度的O-desmethyltramadol。

美國FDA提醒家長及其照顧者應留意兒童在服用tramadol後若出現任何疑似呼吸抑制、呼吸困難或出現雜音、意識混亂、不正常嗜睡等現象，應立即停止服用tramadol並就醫。如有任何有關服用tramadol或其它止痛藥之問題，應向醫療人員諮詢及討論。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
[Posted 09/22/2015]

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