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A bottle of Vicks DayQuil cold and flu medicine containing phenylephrine is displayed for sale in a CVS Pharmacy store in Hawthorne, California, on Sept. 12, 2023.Patrick T. Fallon | AFP | Getty ImagesThe Food and Drug Administration on Thursday proposed ending the use of a common ingredient found in many popular over-the-counter cold and allergy medications.The agency said an extensive review of available data determined that the ingredient, oral phenylephrine, doesn't actually relieve nasal congestion.
2023年9月12日,加利福尼亚州霍桑市CVS药店展示了一瓶含有去氧肾上腺素的Vicks DayQuil感冒和流感药物。Patrick T.Fallon | AFP | Getty Images食品和药物管理局周四建议停止使用许多流行的非处方感冒和过敏药物中的常见成分。该机构表示,对现有数据的广泛审查确定,该成分口服去氧肾上腺素实际上并不能缓解鼻塞。
It comes more than a year after advisors to the FDA unanimously reached the same conclusion.Based on the data, 'we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,' Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a release.The FDA said the proposed order is not based on safety concerns and not final yet, which means companies can still market over-the-counter drugs containing oral phenylephrine for now.
一年多前,FDA的顾问一致得出了同样的结论。FDA药物评估与研究中心主任帕特里齐亚·卡瓦佐尼(PatriziaCavazzoni)博士在一份新闻稿中说,根据这些数据,“我们正在采取下一步行动,建议去除口服去氧肾上腺素,因为它作为鼻腔减充血剂无效。”。美国食品和药物管理局(FDA)表示,拟议的订单并不是基于安全问题,也不是最终决定,这意味着公司目前仍可以销售含有口服去氧肾上腺素的非处方药。
But a final decision would force pharmacies to clear shelves of hundreds of products containing oral forms of the ingredient, which is found in versions of drugs such as NyQuil, Benadryl, Sudafed and Mucinex.Last year, CVS said it has already moved to pull certain medicines containing oral phenylephrine.A final order would also require drugmakers such as Procter & Gamble, Bayer, and Johnson & Johnson spinoff Kenvue to reformulate many of their oral cold and allergy products. Phenylephrine is thought to relieve congestion by reducing the swelling of blood vessels in the nasal passages. Without oral phenylephrine on the market, patients will likely scramble to seek out spray versions of the drug, or other medications with different ingredients,.
但最终决定将迫使药店清理数百种含有该成分口服形式的产品货架,这些成分存在于尼基尔、苯那普利、苏达菲和Mucinex等药物中。去年,CVS表示,它已经开始撤出某些含有口服去氧肾上腺素的药物。最终订单还要求宝洁(Procter&Gamble)、拜耳(Bayer)和强生(Johnson&Johnson)旗下的Kenvue等制药商重新配制其许多口服感冒和过敏产品。苯肾上腺素被认为可以通过减少鼻腔血管的肿胀来缓解充血。如果市场上没有口服去氧肾上腺素,患者可能会争先恐后地寻找该药物的喷雾版本,或其他含有不同成分的药物,。