譯文僅供參考,原文參見FDA官網
11/22/2019: UPDATE – FDA alerts patients and health care professionals to two repackagers』 voluntary recalls of ranitidine
Update [11/22/2019] FDA is alerting patients and health care professionals to two repackagers』 voluntary recalls of ranitidine. The medicines are being recalled because they may contain unacceptable levels of N-nitrosodimethylamine (NDMA).
【20191122更新】FDA警示患者和和醫護專業人員2起再包裝商雷尼替丁主動召回。該藥品召回原因為可能含有NDMA超出可接受水平。
Golden State Medical Supply voluntarily recalled ranitidine capsules (150mg and 300mg), manufactured by Novitium.
Golden State Medical Supply主動召回Novitium生產的雷尼替丁膠囊(150mg 和 300mg)
Precision Dose Inc. voluntarily recalled ranitidine oral solution, USP 150 mg/10 mL, manufactured by Amneal Pharmaceuticals LLC.
Precision Dose Inc.主動召回Amneal Pharmaceuticals LLC.生產的雷尼替丁口服液,USP 150 mg/10 mL
FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine). The agency posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.
FDA已建議公司如檢測發現NDMA超出可接受日攝入水平(96ng/天或雷尼替丁中NDMA濃度0.32ppm)則應召回其雷尼替丁。
Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.
正在使用處方雷尼替丁的患者如希望停藥,應與其醫護人員商量其它治療選擇。目前有多種已批准藥品可用於與雷尼替丁相同或類似的用途。
Consumers taking over-the-counter (OTC) ranitidine may consider using other OTC products approved for their condition. FDA’s tests of samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) show no NDMA in the medicines to date.
正在使用OTC雷尼替丁的消費者可考慮使用其它已批准用於其症狀的OTC藥品。FDA對替代藥品如法莫替丁、西米替丁、埃索美拉唑、蘭索拉唑和奧美拉唑的初步檢測顯示目前這些被檢藥品中不含有NDMA。