FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering
The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.
While we continue to track this safety concern as part of our ongoing monitoring of risks associated with opioid pain medicines, we are requiring changes to the prescribing information for these medicines that are intended for use in the outpatient setting. These changes will provide expanded guidance to health care professionals on how to safely decrease the dose in patients who are physically dependent on opioid pain medicines when the dose is to be decreased or the medicine is to be discontinued.
Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.
Opioids are a class of powerful prescription medicines that are used to manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. They have serious risks, including abuse, addiction, overdose, and death. Examples of common opioids include codeine, fentanyl, hydrocodone, hydromorphone, morphine, oxycodone, and oxymorphone.
Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients. Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient's pain, or psychological distress.
Patients taking opioid pain medicines long-term should not suddenly stop taking your medicine without first discussing with your health care professional a plan for how to slowly decrease the dose of the opioid and continue to manage your pain. Even when the opioid dose is decreased gradually, you may experience symptoms of withdrawal. Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide.
We are continuing to monitor this safety concern and will update the public if we have new information. Because we are constantly monitoring the safety of opioid pain medicines, we are also including new prescribing information on other side effects including central sleep apnea and drug interactions. We are also updating information on proper storage and disposal of these medicines that is currently available on our Disposal of Unused Medicines webpage.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Drugs/DrugSafety/ucm635038.htm?utm_campaign=FDA%20MedWatch-Opioid%20Pain%20Medicines%3A%20Drug%20Safety%20Communication&utm_medium=email&utm_source=Eloqua
Opioid類藥品是一類強效的止痛處方藥，供其他藥品無法服用或無法提供足夠疼痛緩解時使用。 此類藥品有嚴重的風險，包括濫用、成癮、過量和死亡。常見opioid類藥品包含：codeine、fentanyl、hydrocodone、hydromorphone、morphine、oxycodone以及oxymorphone。
美國FDA接獲幾起有關對opioid類止痛藥有依賴性之病人，opioid類藥品突然停止使用或劑量快速減少而產生的嚴重傷害之通報，包含嚴重的戒斷症狀、疼痛不受控制、心理困擾和自殺。
美國FDA持續追蹤此安全性議題，並列入持續監測之opioid類止痛藥相關風險的計畫中，且要求更改這些擬用於門診病人的opioid類藥品之仿單訊息。更動的部分將提供醫療專業人員更多的資訊，包含欲減少劑量或停止服用藥品時，如何安全降低有依賴性病人其opioid類藥品之劑量。
快速停藥可能導致疼痛不受控制或戒斷症狀。這些症狀可能使病人尋求其他opioid類止痛藥，導致與濫用藥物混淆。病人可能會嘗試用非法opioid類藥品（如海洛因）以及其他成份藥品以治療疼痛或戒斷症狀。
對opioid類藥品有依賴性的病人，醫療專業人員不應突然停止其opioid類用藥。當預計減少opioid類藥品之劑量時，請考慮多種因素，包括藥品劑量、使用藥品的時間長短、所治療疼痛類型及病人的身體和心理狀態。目前並無適用於所有病人的opioid類藥物降低劑量的標準建議，必須針對每個病人制定其藥品劑量減量的計劃，並確保需要時能持續監測和給予協助，以避免嚴重的戒斷症狀、病人疼痛惡化或產生心理困擾。
長期服用opioid類藥品的病人不應該在未事先與醫療專業人員討論疼痛控制與減量計畫下，自行突然停止服藥。即使opioid類藥物劑量緩慢減少，亦可能出現戒斷症狀。如果病人出現疼痛加劇、戒斷症狀、情緒變化或自殺念頭，請立即聯繫醫療專業人員。
美國FDA將繼續監控此安全問題，並持續更新。因為美國FDA持續監測opioid類藥品的相關風險，仿單已更新其他副作用包括中樞性睡眠呼吸暫停及相關藥物相互作用之訊息，有關此類藥物的正確儲存和處置的資訊，可參考美國FDA網站。
更多訊息與連結請參考FDA網址：
https://www.fda.gov/Drugs/DrugSafety/ucm635038.htm?utm_campaign=FDA%20MedWatch-Opioid%20Pain%20Medicines%3A%20Drug%20Safety%20Communication&utm_medium=email&utm_source=Eloqua
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
[Posted 4-9-2019]
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