Danish drugmaker Novo Nordisk is now in focus and is facing scrutiny from the US Food and Drug Administration (FDA). On Tuesday (local time) said that it received a warning letter from the FDA for failing to report all suspected side effects experienced by patients using Ozempic, Bloomberg reported.
Nausea, vomiting, diarrhea, abdominal pain, constipation, and fatigue are known side effects of Ozempic, the diabetes drug now widely used for weight management, NDTV reported. Other reported effects include pancreatitis, kidney problems, allergic reactions, and gallbladder issues. Despite these risks, GLP-1 receptor agonists continue to be widely used for weight loss.
The agency noted in a letter dated March 5 and its accompanying report that the cases involved two deaths and one suicide. However, the FDA did not specify whether these deaths or other reported side effects were directly linked to Ozempic.
Will address FDA’s concerns: Novo
The drugmaker, in a statement, said it will address the concerns flagged by the FDA “expeditiously and holistically,” adding that it has been working with the agency to develop an action plan since an inspection in 2025.
Novo vs Eli Lily
The warning letter arrives as Novo struggles to regain patients in the expanding obesity drug market, including Ozempic and similar treatments, where it has fallen behind competitor Eli Lilly & Co. The US remains the largest market for these medications.
The drugmaker’s shares declined nearly 3.3% in Copenhagen. Since January, the shares have declined nearly 22% through Monday’s close as investors flagged concerns over its position in the obesity drug market.
The FDA said that the Danish drugmaker has yet to demonstrate how its planned changes will prevent similar violations in the future.
FDA inspection
The Bloomberg report cited the FDA’s inspection report and said that in April 2024, the drugmaker discovered that it had failed to properly report serious adverse events involving its blockbuster drug Ozempic and others dating back to 2020. While it tried to address the issue, an inspection by FDA investigators in 2025 at Novo’s US headquarters in Plainsboro, New Jersey, discovered over 300 unsubmitted reports, some delayed by over 1,000 days. The cases included at least four deaths and a suicide.
It further said that the drugmaker did not probe when a doctor informed the company representative that a patient taking Ozempic, the semaglutide, was depressed and died by suicide later. In another instance, Novo also failed to follow up on deaths, allegedly because the reporter was not a health professional or because the patient’s identity was not revealed. However, the FDA was able to obtain this crucial information. The company has said that since then, it has reviewed these cases and ensured that everything was processed properly and reported.
The FDA has also flagged Novo’s several company procedures as noncompliant, which include a policy that allowed potential adverse events to be withheld if the reporter believed the issue was unrelated to the drug. This is despite the fact that FDA rules require all serious and unexpected health events to be reported.
Separately, the FDA’s recent review found no evidence that GLP-1 drugs such as Ozempic increase the risk of suicidal thoughts or behaviors. In January, the agency instructed companies to remove suicide-related warnings from weight-loss drug labels.
How does Ozempic work?
According to an NDTV report, Ozempic prompts the pancreas to release insulin when a person’s blood sugar is high, and helps in lowering post-meal glucose levels. Additionally, it delays the movement of food from the stomach to the intestines, promoting longer-lasting fullness and preventing blood sugar spikes. The GLP-1 receptor agonist also targets the region of the brain that controls hunger, and can result in reduced cravings and overall food intake.
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