Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring Boxed Warning About Serious Risks and Death
AUDIENCE: Pharmacy, Internal Medicine, Psychiatry, Neurology, Family Practice
ISSUE: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, FDA is adding Boxed Warnings, our strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines. See the Drug Safety Communication for a listing of all approved prescription opioid pain and cough medicines, and benzodiazepines and other CNS depressants.
FDA conducted and reviewed several studies showing that serious risks are associated with the combined use of opioids and benzodiazepines, other drugs that depress the CNS, or alcohol (see the FDA Drug Safety Communication for a Data Summary). Based on these data, FDA is requiring several changes to reflect these risks in the opioid and benzodiazepine labeling, and new or revised patient Medication Guides. These changes include the new Boxed Warnings and revisions to the Warnings and Precautions, Drug Interactions, and Patient Counseling Information sections of the labeling.
FDA is continuing to evaluate the evidence regarding combined use of benzodiazepines or other CNS depressants with medication-assisted therapy (MAT) drugs used to treat opioid addiction and dependence. FDA is also evaluating whether labeling changes are needed for other CNS depressants, and will update the public when more information is available.
BACKGROUND: Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. Benzodiazepines are a class of medicines that are widely used to treat conditions including anxiety, insomnia, and seizures.
RECOMMENDATION: Health care professionals should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate. If these medicines are prescribed together, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms. Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol.
Patients taking opioids with benzodiazepines, other CNS depressant medicines, or alcohol, and caregivers of these patients, should seek medical attention immediately if they or someone they are caring for experiences symptoms of unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm518710.htm
Opioids類藥品常被使用於當其它藥品無法緩解疼痛時的強效止痛藥，而benzodiazepines類藥品則被廣泛使用於治療焦慮、失眠和癲癇。美國FDA在回顧多項研究後發現，併用opioids類及benzodiazepines類藥品或其他中樞神經系統抑制劑（如：酒精）可能會導致呼吸速率變慢、呼吸困難，甚至死亡等嚴重副作用。因此，美國FDA將修訂opioids類及benzodiazepines類藥品仿單之加框警語、注意事項、藥品交互作用以及病人用藥須知，並持續評估併用benzodiazepines類藥品或其它中樞神經抑制劑用於治療opioid藥品成癮之輔助療法之相關依據。另有關其他中樞神經系統抑制劑是否需同步修訂，美國FDA將進行更多的評估後再公告。
美國FDA建議醫療人員在開立處方時，應盡量避免併用opioids類藥品和benzodiazepines類藥品或其他中樞神經系統抑制劑。若因其他替代治療方法不足以控制疾病，而不得不併用者，應使用足以達到理想治療效果之最低劑量和療程。此外，醫療人員應衛教病人及其照顧者有關呼吸抑制及鎮靜之風險與臨床症狀（如：異常之眩暈、頭昏眼花、極度嗜睡、反應遲鈍、呼吸減緩或呼吸困難等）。也應留意避免給予opioids類止咳劑於正在使用benzodiazepines類藥品或其他中樞神經系統抑制劑（包含酒精）。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm518710.htm
[Posted 08/31/2016]
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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