藥品召回,例如 FDA 最近關於度洛西汀的公告,往往會帶來更廣泛的影響,波及整個社會。
The Food and Drug Administration (FDA) recently announced a significant recall affecting over 7,000 bottles of an antidepressant medication due to contamination concerns. The Class II recall began on October 10, targeting a lot of Duloxetine, a widely used treatment for mental health conditions, manufactured by Towa Pharmaceutical Europe.
由於污染問題,美國食品藥物管理局 (FDA) 最近宣布重大召回,涉及 7,000 多瓶抗憂鬱藥物。 II 級召回於 10 月 10 日開始,針對大量度洛西汀(Duloxetine),這是一種廣泛用於治療精神健康疾病的藥物,由 Towa Pharmaceutical Europe 生產。
Duloxetine, commonly marketed as Cymbalta, is prescribed for disorders such as anxiety and depression. The recall, however, stems from the presence of N-nitroso-duloxetine, a nitrosamine impurity which could potentially increase cancer risks. Despite the recall, the FDA reassures that long-term exposure at acceptable levels is unlikely to cause harm.
度洛西汀(Duloxetine)通常被稱為 Cymbalta,用於治療焦慮和憂鬱等疾病。然而,此次召回源於 N-亞硝基-度洛西汀的存在,這是一種亞硝胺雜質,可能會增加癌症風險。儘管進行了召回,FDA 仍保證,長期接觸在可接受的水平下不太可能造成傷害。
Precisely 7,107 bottles, including 500-count delayed-release capsules, have been recalled. The specific batch affected is lot #220128, with an expiration of December 2024. According to the FDA, the Class II designation indicates possible temporary health consequences that may be medically reversible.
總共有 7,107 瓶被召回,其中包括 500 粒緩釋膠囊。受影響的具體批次號碼為批次號 220128,有效期為 2024 年 12 月。
Consumers are advised to immediately discontinue use of the affected medication and consult healthcare providers for alternative treatments. The FDA emphasizes the importance of discussing concerns and potential options with medical professionals.
建議消費者立即停止使用受影響的藥物,並諮詢醫療保健提供者尋求替代治療。 FDA 強調與醫療專業人員討論問題和潛在選擇的重要性。
Nitrosamines are common in various foods and products, and everyone encounters minute amounts; however, excessive exposure over time could heighten cancer risks. This contaminant has previously led to recalls of numerous medications, including heartburn remedies and blood pressure drugs, underscoring the ongoing vigilance needed in pharmaceutical safety.
亞硝胺常見於各種食品和產品中,每個人都會遇到微量的亞硝胺。然而,隨著時間的推移,過度暴露可能會增加癌症風險。這種污染物先前已導致多種藥物被召回,包括胃灼熱藥物和降血壓藥物,這凸顯了藥品安全方面需要持續保持警惕。