Imodium (loperamide) for Over-the-Counter Use: Drug Safety Communication - FDA Limits Packaging To Encourage Safe Use
AUDIENCE: Consumer, Pharmacy, Family Practice
ISSUE: To foster safe use of the over-the counter (OTC) anti-diarrhea drug loperamide, FDA is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. FDA continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label and a previous communication. Loperamide is a safe drug when used as directed.
Loperamide acts on opioid receptors in the gut to slow the movement in the intestines and decrease the number of bowel movements. It is safe at approved doses, but when much higher than recommended doses are taken, it can lead to serious problems, including severe heart rhythm problems and death.
FDA is continuing to evaluate this safety issue and will update the public when more information is available.
BACKGROUND: Loperamide is FDA-approved to help control symptoms of diarrhea, including Travelers' Diarrhea. The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use. It is sold under the OTC brand name Imodium A-D, as store brands, and as generics.
FDA previously issued a Drug Safety Communication about this safety concern in 2016, and added warnings about serious heart problems to the drug label of prescription loperamide and to the Drug Facts label of OTC loperamide products.
RECOMMENDATION: Patients and consumers should only take the dose of loperamide directed by your health care professionals or according to the OTC Drug Facts label, as taking more than prescribed or listed on the label can cause severe heart rhythm problems or death. If you are using OTC loperamide and your diarrhea lasts more than 2 days, stop taking the medicine and contact your health care professional.
Seek medical attention immediately by calling 911 if you or someone taking loperamide experiences any of the following, and tell health care professionals the person has been taking loperamide:
• Fainting
• Rapid heartbeat or irregular heart rhythm
• Unresponsiveness, meaning that you can't wake the person up or the person doesn't answer or react normally
Health care professionals should be aware that using much higher than recommended doses of loperamide, either intentionally or unintentionally, can result in serious cardiac adverse events, including QT interval prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope, and cardiac arrest. In cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects. Some individuals are taking high doses of loperamide to treat symptoms of opioid withdrawal. If loperamide toxicity is suspected, promptly discontinue the drug and start necessary therapy. For some cases of abnormal heart rhythms in which drug treatment is ineffective, electrical pacing or cardioversion may be required. Also counsel patients to take loperamide only as prescribed or according to the OTC Drug Facts label and advise patients that drug interactions with commonly used medicines may increase the risk of serious cardiac events.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm594403.htm
Loperamide作用於腸道中的opioid受體以減緩腸道蠕動並減少排便次數，美國FDA核准loperamide於幫助控制腹瀉症狀，包括旅行者腹瀉(Travelers' Diarrhea)。成人最大建議每日劑量為非處方藥8 mg和處方藥16 mg。依照建議劑量使用是安全的，然而當使用劑量遠高於建議劑量時，會導致嚴重的心律問題和死亡等藥品不良反應。美國FDA於2016年曾對此安全問題發布了藥品安全溝通，並於處方及非處方藥之loperamide藥品仿單中增加有關嚴重心臟問題的警語。並且為了更安全使用loperamide非處方藥，美國FDA正在與製造商協商使用blister（PTP）包裝或其他單劑量包裝，並限制包裝中的藥品數量。
然而儘管在藥品仿單及藥品安全溝通表上增加警示，美國FDA仍然持續收到使用遠高於建議劑量的loperamide而導致嚴重心臟問題和死亡的報告，主要出現於故意誤用或藥品濫用的人。美國FDA正在繼續評估此安全問題，如有更多資訊將隨時更新。
病人及消費者使用loperamide時應遵循醫療專業人員或非處方藥仿單中之劑量建議，因為服用超過建議劑量可能導致嚴重的心律問題或死亡。如果病人正在使用loperamide非處方藥，但腹瀉仍持續2天以上，請停止服用該藥並聯繫醫療專業人員。服用loperamide的人若出現昏倒、心跳太快或心律不整、沒反應或不能正常反應，請立即撥打救護車尋求醫療救助，並告訴醫療專業人員目前正在服用loperamide。
醫療專業人員應了解，有藉由其他藥品和loperamide併用，增加loperamide的吸收以及血腦屏障的穿透率，並抑制loperamide之代謝以增強其欣快作用。而濫用loperamide的案例；亦有服用高劑量的loperamide治療opioid之戒斷症狀的案例。無論蓄意或無意使用遠高於建議劑量的loperamide可能導致嚴重的心臟相關不良事件，包括延長QT間隔(QT interval prolongation)、心律不整(Torsades de Pointes or other ventricular arrhythmias)、暈厥或心臟驟停。如懷疑為loperamide之藥品毒性，應立即停用該藥並開始必要的治療。對於某些藥品治療無效的心律異常的病例，可能需要電擊。同時告知病人只能按照處方或藥品仿單之指示服用loperamide，並提醒病人loperamide與常用藥品的交互作用可能會增加嚴重心臟事件的風險。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm594403.htm
[Posted 1/30/2018]
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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