药品召回,例如 FDA 最近关于度洛西汀的公告,往往会带来更广泛的影响,波及整个社会。
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.
由于污染问题,美国食品和药物管理局 (FDA) 最近宣布重大召回,涉及 7,000 多瓶抗抑郁药物。 II 级召回于 10 月 10 日开始,针对大量度洛西汀(Duloxetine),这是一种广泛用于治疗精神健康疾病的药物,由 Towa Pharmaceutical Europe 生产。
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)通常被称为 Cymbalta,用于治疗焦虑和抑郁等疾病。然而,此次召回源于 N-亚硝基-度洛西汀的存在,这是一种亚硝胺杂质,可能会增加癌症风险。尽管进行了召回,FDA 仍保证,长期接触在可接受的水平下不太可能造成伤害。
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.
总共有 7,107 瓶被召回,其中包括 500 粒缓释胶囊。受影响的具体批次号为批次号 220128,有效期为 2024 年 12 月。根据 FDA 的说法,II 类指定表明可能产生暂时的健康后果,这些后果在医学上可能是可逆的。
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.
建议消费者立即停止使用受影响的药物,并咨询医疗保健提供者寻求替代治疗。 FDA 强调与医疗专业人员讨论问题和潜在选择的重要性。
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.
亚硝胺常见于各种食品和产品中,每个人都会遇到微量的亚硝胺。然而,随着时间的推移,过度接触可能会增加癌症风险。这种污染物此前已导致多种药物被召回,包括胃灼热药物和降血压药物,这凸显了药品安全方面需要持续保持警惕。