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[Posted 09/23/2020]
Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: The FDA is requiring the Boxed Warning, FDA's most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. The FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.
Other changes are also being required to several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.
BACKGROUND: Benzodiazepines are a class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder.
RECOMMENDATION:
Health Care Professionals
• Consider the patient's condition and the other medicines being taken, and assess the risk of abuse, misuse, and addiction.
• Limit the dosage and duration of each medicine to the minimum needed to achieve the desired clinical effect when prescribing benzodiazepines, alone or in combination with other medicines.
• Use a gradual taper to reduce the dosage or to discontinue benzodiazepines to reduce the risk of acute withdrawal reactions.
• Take precautions when benzodiazepines are used in combination with opioid addiction medications.
Patients, Parents, and Caregivers
• Always tell your health care professionals about all the prescription and over-the-counter (OTC) medicines you are taking or any other substances you are using, including alcohol.
• Take benzodiazepines and all medicines exactly as prescribed by your health care professional
• Discuss a plan for slowly decreasing the dose and frequency of your benzodiazepine(s) with your health care professional.
• Contact your health care professional if you experience withdrawal symptoms or your medical condition worsens.
• Go to an emergency room or call 911 if you have trouble breathing or other serious side effects such as seizures.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://pse.is/wlqsb
Benzodiazepines類藥品核可用於治療焦慮症、失眠、癲癇、社交恐懼症及恐慌症。美國FDA要求在所有benzodiazepine類藥品仿單中更新加框警語（美國FDA藥物安全警語中最嚴重的級別）。更新內容包含此類藥品發生濫用、誤用、成癮、生理性依賴和戒斷反應的風險。美國FDA亦要求更新病人用藥指南，以幫助教育病人和其照護者有關這類風險。美國FDA也要求仿單其他相關段落也需要進行更新，包括警告和注意事項、藥物濫用和依賴性及病人用藥須知。
建議醫療專業人員：
－ 考慮病人的病情和其他服用的藥物，並評估病人濫用、誤用和成癮的風險。
－ 處方benzodiazepines以最低有效劑量和最短臨床治療天數為原則。
－ Benzodiazepines類藥物減量或停藥，需採取逐漸降低劑量的方式，以減少發生急性戒斷症狀的風險。
－ 當benzodiazepines類藥物與opioid類成癮藥物合併使用時，請小心使用。
建議病人、家長及其照顧者：
－ 請告知醫療專業人員目前正在服用的所有處方藥和非處方藥（over-the-counter, OTC）或正在使用的任何其他物質（包括酒精）。
－ 請切實遵照醫療專業人員之處方，服 用benzodiazepines類及所有藥物。
－ 欲調降benzodiazepines類藥物劑量和頻率，請先與醫療專業人員討論。
－ 若出現戒斷症狀或病情惡化，請與醫療專業人員聯繫。
－ 若呼吸困難或其他嚴重副作用（例如癲癇發作），請立即至急診就醫或連絡119。
更多相關訊息與連結請參考FDA網址：https://pse.is/wlqsb
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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