關於鹽酸曲馬多(tramadol hydrochloride)﹑質子泵抑制劑(PPIs)和奧利司他(orlistat, Xenical®)安全性的最新資訊 Latest safety updates on tramadol hydrochloride, proton pump inhibitors (PPIs) and orlistat(Xenical®)

    美國食物及藥物管理局(USFDA)通知衛生專業人士以下三則分別關於鹽酸曲馬多(tramadol hydrochloride)﹑質子泵抑制劑(PPIs)和奧利司他(orlistat, Xenical®)安全性的最新資訊:

1.  生產商在tramadol hydrochloride的說明書中強調關於具成癮傾向患者使用該藥, 以及併用鎮靜劑和抗抑鬱藥的病人可能出現自殺的風險, 當中亦包括服藥過量的風險。資料顯示, 與tramadol有關的死亡個案曾發生於具有情緒困擾病史﹑曾企圖自殺以及曾濫用鎮靜劑﹑酒精和其他中樞興奮劑的病人。過量使用tramadol的嚴重後果包括中樞神經系統抑制﹑呼吸抑制﹑甚至死亡。因此, USFDA對醫生和其他衛生專業人士作出下列建議:

  • 不要向具有自殺或藥物成癮傾向的病人處方tramadol
  • 對於正在服用鎮靜劑或抗抑鬱藥﹑過量飲用酒精以及患有情緒困擾或抑鬱的病人, 謹慎處方該藥。
  • 對於抑鬱或具有自殺傾向的病人, 可考慮使用非麻醉性鎮痛藥。
  • 提醒服用tramadol的病人, 當併用酒精﹑其他阿片類藥物或違法藥物會加倍抑制中樞神經系統。
  • 在處方和/或調配tramadol時, 應注意病人非法使用該藥﹑成癮傾向及用於娛樂的可能性和風險。
  • 為避免服藥過量的風險, 警告病人不要服用超出醫生處方的使用劑量。

 

2. 基於USFDA對數個流行病學的回顧性研究, 總結出服用質子泵抑制劑(PPIs)的病人可出現髖部﹑手腕和脊椎骨折的風險。某些研究發現, 服用高劑量的PPIs或服用超過一年的病人, 出現骨折的風險較高, 然而研究群體的大部份人士年齡超過50歲, 因此主要是在這群人士中觀察到骨折風險的增加。衛生專業人士在處方或調配PPIs時, 應緊記下列各項:

  • 對於入侵性食道炎﹑非類固醇消炎藥引致的胃潰瘍及胃-食管反流性疾病, PPIs在大多數病人中都能提供顯著的療效。
  • 警惕某些觀察性研究關於使用PPIs的病人出現髖部﹑手腕和脊椎骨折風險增高的發現。
  • 當處方PPIs時, 考慮對於病人的狀況是否可用較低的劑量或較短的療程。
  • 對骨質疏鬆的病人, 應按照現行的臨床實踐處理該病, 也應補充充足的維他命D和鈣補充劑。
  • 向病人提供下列資訊:

       i.  PPIs對於一系列的胃腸疾病都是有效的, 除非醫生指示, 否則不應停用。

      ii.  使用PPIs的病人應注意可能出現的髖部﹑手腕和脊椎骨折, 在決定使用PPIs時, 應衡量已知的效益及風險。

      iii. 骨折的風險最常發生於服用高劑量的PPIs或服用超過一年的病人。

      iv. 如病人對於使用PPIs有任何疑問, 應咨詢醫生﹑藥劑師或其他衛生專業人士。

 3. 過去曾發生服用orlistat (Xenical®)後引致嚴重肝損傷的個案。目前為止, 雖然並不能確立使用orlistat與嚴重肝損傷的因果關係, 然而, 基於可能出現的肝損傷的嚴重性, USFDA向衛生專業人士及公眾發出以下資訊:

  • 須警惕orlistat曾引致罕見的伴有肝細胞壞死的嚴重肝損傷, 當中部份病人需進行肝移植, 甚至死亡。
  • 在處方或調配orlistat於任何病人前, 需衡量使用後體重減輕的益處以及潛在的風險。
  • 如病人在服藥期間出現肝受損, 應要求病人立即停止服用orlistat及其他懷疑的藥物, 以及進行肝功能測試, 如檢測ALT及AST。
  • 教導正在服用orlistat的病人
  • 須警惕orlistat曾罕有地引致嚴重肝損傷。
  • 如出現痕癢、眼睛或皮膚變黃﹑尿液變黑﹑體重減輕或糞便色澤變淺的症狀, 須立即聯絡醫生或藥劑師。上述症狀可能是肝損傷的症狀。
  • 如對於服用該藥有任何疑問, 應諮詢醫生﹑藥劑師或其他衛生專業人士。

 

    The United Stated Food and Drug Administration(USFDA) would like to inform health professionals about two updates respectively on tramadol hydrochloride and proton pump inhibitors (PPIs):

1. New warnings were added to the labeling information of tramadol hydrochloride about the risk of suicide for patients who are addiction-prone, taking tranquilizers or antidepressants and also about the risk of overdosage.  Tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression and death. Therefore, USFDA offers the following reminders for the physicians and other healthcare professionals:

  • Do not use tramadol for patients who are suicidal or addiction-prone.
  • Prescribe with caution for patients who are already on tranquilizers or antidepressants, drink alcohol excessively and for those patients suffering from emotional disturbance or depression.
  • Consider using non-narcotic analgesic in patients who are depressed or suicidal.
  • Remind patients tramadol may be expected to have additive effets when used in conjunction with alcohol, other opiods, or illicit drugs that cause CNS depression while on tramadol.
  • Be aware of the possibility & risk of illegal or illicit use, addiction, abusive uses and criminal diversion of tramadol during prescribing and/or dispensing.
  • Warn patients not to exceed the recommended doses as instructed by their physicians so as to avoid the risk of overdose.

2.  Based on USFDA's review on several epidemiological studies, it was reported that an increased risk of fractures of the hip, wrist, and spine for patients who have been using proton pump inhibitors (PPIs). Some studies found that those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more.  The majority of the subject population being studied and evaluated include individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. It is important that healthcare professionals to remember the following upon prescribing or dispensing proton pump inhibitor :

  • Proton pump inhibitors provide important benefits for many patients in treating or preventing conditions such as erosive esophagitis, nonsteroidal anti-inflammatory drug-induced ulcers and gastroesophageal reflux disease.
  • Be aware of the increased risk of fractures of the hip, wrist, and spine seen in some observational studies in patients using proton pump inhibitors.
  • When prescribing proton pump inhibitors, consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.
  • Individuals at risk for osteoporosis should have their bone status managed according to current clinical practice, and should take adequate vitamin D and calcium supplementation.
  • Offer the following information for the patients

       i.  Proton pump inhibitors are effective in treating a variety of gastrointestinal disorders. Do not stop taking their proton pump inhibitor unless told to do so by their healthcare professional.

      ii.   Users of proton pump inhibitors should be aware of the possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors, and weigh the known benefits against the potential risks when deciding to use them.

     iii. The greatest increased risk for these fractures was seen in patients who receive high dosed of these medications or use them longer(a year or more).

     iv. Talk to doctor, pharmacist or other healthcare professional about any concerns they may have about using proton pump inhibitors.

3.  Cases of severe liver injury that have been reported rarely with the use of orlistat (Xenical®). At this time, although a cause and effect relationship of severe liver injury with orlistat use has not been established, however, due to the seriousness of severe liver injury, the Agency would like to inform both the healthcare professionals and the public about the following information:

  • Be aware that rarely reported postmarketing cases of severe liver injury with hepatocellular necrosis or acute hepatic failure and in some of these cases resulted in liver transplant or death subsequent to the use of orlistat.
  • Weigh the benefits of weight-loss with orlistat against the potential risks before prescribing or dispensing them to any patient.
  • If liver injury is suspected of hepatic dysfunction when using these medications, orlistat and other suspect medications should be discontinued immediately and liver function tests and ALT and AST levels obtained.
  • Instruct patients who are on orlistat
  • to be aware that cases of severe liver injury have been reported rarely in people taking orlistat.
  • to report and contact your physician or pharmacist if they develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.
  • talk to their physicians, pharmacists or other healthcare professional about any concerns they have with these medications.

 

參考資料/Reference and websites:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213264.htm

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213321.htm

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213448.htm


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