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制药商停止生产芬太尼“棒棒糖”:美国食品药品监督管理局

Drugmakers to discontinue Fentanyl 'lollipops': FDA

Becker's Hospital Review 等信源发布 2024-09-21 04:39

可切换为仅中文


Drugmakers will discontinue the sales of a controversial class of fentanyl-based painkillers by the end of September, the FDA confirmed Sept. 16. The medications, known as transmucosal immediate release fentanyl, include products such as Actiq, a fentanyl lozenge on a stick often referred to as a 'fentanyl lollipop,' and fentora, a dissolvable tablet.

FDA于9月16日确认,制药商将在9月底前停止销售一类备受争议的芬太尼止痛药。这种药物被称为透粘膜速释芬太尼,包括Actiq(一种通常被称为“芬太尼棒棒糖”的芬太尼含片)和fentora(一种可溶性片剂)等产品。

These drugs, initially approved for managing breakthrough pain in cancer patients who are opioid tolerant, have been linked to fueling the opioid overdose crisis in the U.S., CBS News reported Sept.19. The decision to cease production comes after decades of controversy and lawsuits surrounding the marketing practices for these drugs.

哥伦比亚广播公司新闻(CBS News)9月19日报道,这些药物最初被批准用于治疗阿片类药物耐受性癌症患者的突破性疼痛,与美国阿片类药物过量危机的加剧有关。停止生产的决定是在围绕这些药物营销实践的数十年争议和诉讼之后做出的。

Both TIRF drugs were aggressively marketed beyond their approved use, leading to widespread 'off-label' prescriptions, the report said. Despite FDA restrictions, drugmakers, including Cephalon and later its parent company Teva pharmaceuticals, faced lawsuits for downplaying the drug's addiction risks and promoting the medication to patients without cancer, according to CBS News. The FDA said in a Sept.

报告称,这两种TIRF药物都在批准的使用范围之外积极销售,导致广泛的“标签外”处方。据哥伦比亚广播公司新闻(CBS News)报道,尽管美国食品和药物管理局(FDA)有限制,但包括Cephalon及其母公司Teva pharmaceuticals在内的制药商仍面临诉讼,因为他们淡化了该药物的成瘾风险,并将该药物推广给无癌症患者。美国食品和药物管理局在9月的一次会议上表示。

16 news release that patients already using the drugs may continue treatment while supplies last, while encouraging healthcare providers to transition patients to alternative therapies. .

16新闻稿称,已经使用这些药物的患者可能会在最后一次供应时继续治疗,同时鼓励医疗保健提供者将患者转变为替代疗法。。