Opioid Addiction Medications in Patients Taking Benzodiazepines or CNS Depressants: Drug Safety Communication - Careful Medication Management Can Reduce Risks
AUDIENCE: Health Professional, Pain Management
ISSUE: Based on additional review, FDA is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction usually outweighs these risks. Careful medication management by health care professionals can reduce these risks. FDA is requiring this information to be added to the buprenorphine and methadone drug labels along with detailed recommendations for minimizing the use of medication-assisted treatment (MAT) drugs and benzodiazepines together.
BACKGROUND: Many patients with opioid dependence may also use benzodiazepines or other CNS depressants, either under a health care professional’s direction or illicitly. Although there are serious risks with combining these medicines, excluding patients from MAT or discharging patients from treatment because of use of benzodiazepines or CNS depressants is not likely to stop them from using these drugs together. Instead, the combined use may continue outside the treatment setting, which could result in more severe outcomes.
RECOMMENDATIONS: Health care professionals should take several actions and precautions and develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants. These include:
‧ Educating patients about the serious risks of combined use, including overdose and death, that can occur with CNS depressants even when used as prescribed, as well as when used illicitly.
‧ Developing strategies to manage the use of prescribed or illicit benzodiazepines or other CNS depressants when starting MAT.
‧ Tapering the benzodiazepine or CNS depressant to discontinuation if possible.
‧ Verifying the diagnosis if a patient is receiving prescribed benzodiazepines or other CNS depressants for anxiety or insomnia, and considering other treatment options for these conditions.
‧ Recognizing that patients may require MAT medications indefinitely and their use should continue for as long as patients are benefiting and their use contributes to the intended treatment goals.
‧ Coordinating care to ensure other prescribers are aware of the patient’s buprenorphine or methadone treatment.
‧ Monitoring for illicit drug use, including urine or blood screening.
Patients taking MAT drugs should continue to take these medicines as prescribed. Do not stop taking other prescribed medicines without first talking to your health care professional. Before starting any new medicines, tell your health care professional that you are taking MAT. Do not take non-prescribed benzodiazepines or other sedatives (See Table 2 in the Drug Safety Communication, List of Benzodiazepines and Other CNS Depressants) or use alcohol when taking MAT because the combined use increases the possibility of harm, including overdose and death.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm576755.htm
根據文獻回顧，美國FDA發布藥物安全警訊，使用benzodiazepines或是其他中樞神經抑制劑之病人不能被排除於使用鴉片成癮性藥物buprenorphine以及methadone治療(以下統稱為medication-assisted treatment (MAT) drugs)。雖然MAT drugs合併使用這類中樞神經抑制劑可能增加嚴重副作用發生之風險，然而鴉片成癮症若不治療所產生的後續傷害更大。醫療專業人員制訂完善的藥物計畫，可降低風險。另外美國FDA也要求將此資訊加入buprenorphine以及methadone之仿單中，以盡量減少合併使用此兩類藥物之可能性。
不論是醫療專業人員的指示下，抑或是自行使用，許多鴉片依賴性病人可能會合併使用benzodiazepines或是其他中樞神經抑制劑。雖然合併使用此兩類藥物可能會有嚴重風險，但是因此排除正在使用benzodiazepines或是其他中樞神經抑制劑之病人使用MAT drugs治療鴉片依賴性，並不能有效阻止病人自行於醫療院所外合併使用此兩類藥品，相反的還可能導致更多嚴重的結果。
醫療專業人員在進行MAT drugs治療時，若病人同時併用benzodiazepines或是其他中樞神經抑制劑時，需制訂治療計畫並小心使用，包含：
1. 教育病人不論其benzodiazepines或中樞神經抑制劑是自行使用或由醫療人員開方，合併使用此兩類藥物可能導致的嚴重風險，包含藥物過量(overdose)，甚至死亡。
2. 開始使用MAT drugs時，需制訂使用benzodiazepines或其他中樞神經抑制劑之策略。
3. 盡可能緩慢減低benzodiazepines或其他中樞神經抑制劑之劑量，直至停藥。
4. 若病人正在使用benzodiazepines或其他中樞神經抑制劑以治療焦慮或失眠，請再度確認診斷及考慮使用別種藥物治療。
5. 了解只要病人使用MAT drugs治療是有助益，即可能需無限期使用MAT治療，直至達到治療目標。
病人使用MAT drugs應該持續依照醫囑使用。在與醫療專業人員討論前，不可任意自行停用任何藥物。在新使用任何藥物前，皆需告知醫療專業人員目前正在進行MAT治療。不可在MAT治療的過程中，自行使用benzodiazepines、其他中樞神經抑制劑或喝酒，因為可能會導致嚴重風險，包含藥物過量或是死亡。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm576755.htm
[Posted 09/20/2017]
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
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