更新于：2026年3月10日 / 美国东部时间下午1:50 / CBS新闻
诺和诺德（Novo Nordisk）——旗下拥有Ozempic的制药公司——因未按程序报告其旗舰糖尿病药物（同时也用于减肥）的潜在副作用问题，收到了美国食品药品监督管理局（FDA）的警告信。
在3月5日发出的信件中，FDA指出在使用司美格鲁肽（semaglutide，即诺和诺德Ozempic和Wegovy中的活性成分）的患者中发生了三起死亡事件，据称这些死亡案例未得到适当报告。FDA称，其中包括1起自杀事件，另一起涉及服用司美格鲁肽期间报告有自杀意念的患者。
FDA并未猜测这些死亡或其他副作用是否必然与药物相关。其信件主要关注诺和诺德显然违反了报告可能与药物相关的不良症状的协议。
FDA调查人员在2025年初对这家丹麦制药商位于新泽西州普莱恩斯伯勒的美国总部进行检查时，发现了其报告合规性问题。此次检查是FDA生物研究监测计划（Bioresearch Monitoring Program）的一部分，旨在确保准确及时地向FDA提交产品安全信息。
诺和诺德周二回应了FDA的警告信，在声明中表示自去年检查以来，公司”一直努力解决该机构的关切”。该公司称，信件主要要求提供更多关于自检查以来公司为遵守上市后药物不良反应（PADE）法规所采取措施的细节，但信件”并未对我们药物的质量或安全性做出任何结论”。
诺和诺德美国公司临床开发、医学和法规事务负责人安娜·温德尔（Anna Windle）表示：”诺和诺德高度重视PADE报告要求，我们计划迅速全面地回应警告信中的要求。我们有信心将FDA警告信中概述的问题解决至其完全满意。”
FDA近期的另一项评估确定，自杀与Ozempic或Wegovy等GLP-1类药物之间没有关联。该机构在1月份要求移除这些药物关于自杀行为或意念的黑框警告。
FDA warns Novo Nordisk over unreported potential Ozempic side effects
Updated on: March 10, 2026 / 1:50 PM EDT / CBS News
Novo Nordisk, the pharmaceutical company behind Ozempic, has received a warning letter from the U.S. Food and Drug Administration over issues with its procedures for reporting potential side effects of the flagship diabetes drug, which is also prescribed for weight loss.
In the letter, dated March 5, the FDA cited three deaths among patients receiving semaglutide, the generic name for the medication in Novo Nordisk’s Ozempic and Wegovy, which were allegedly not reported properly to the agency. Those deaths included one suicide, according to the FDA. Another instance involved a patient that reported suicidal ideations while taking semaglutide.
The FDA did not speculate as to whether the deaths or other side effects were necessarily linked to the medication. Its letter focused on the fact that Novo Nordisk apparently violated its protocols for reporting adverse symptoms that could potentially be tied to the drug.
FDA investigators discovered problems with Novo Nordisk’s reporting compliance when it conducted an inspection at the Danish drugmaker’s U.S. headquarters in Plainsboro, New Jersey, in early 2025. It was conducted as part of the agency’s Bioresearch Monitoring Program, which aims to ensure that accurate and timely information about product safety is submitted to the FDA for monitoring.
Novo Nordisk responded to the FDA’s warning letter on Tuesday, saying in a statement that it had been “working diligently” to address the agency’s concerns since its inspection took place last year. The company said the letter largely sought more details about the steps the company has taken since the inspection to comply with post-marketing adverse drug experience, or PADE, regulations. But the letter did not “make any conclusions about the quality or safety of our medicines,” the company said.
“Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” said Anna Windle, the head of clinical development, medical and regulatory affairs at Novo Nordisk U.S. “We are confident that we will resolve the matters outlined in Warning Letter to the FDA’s full satisfaction.”
Another recent evaluation by the FDA determined that there was no connection between suicide and GLP-1 drugs such as Ozempic or Wegovy. The agency in January requested the removal of boxed warnings for suicidal behavior or ideation from those medications.
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