Ozempic’s drug maker, Novo Nordisk, receives FDA warning letter over unreported side effects: What are they?
Danish drugmaker Novo Nordisk is now in the spotlight and faces scrutiny from the US Food and Drug Administration (FDA). It said on Tuesday (local time) that it had received a warning letter from the FDA for failure to report all suspected side effects experienced by patients using Ozempic. Bloomberg reported.
Known side effects of Ozempic, a diabetes medication commonly used for weight control, include nausea, vomiting, diarrhea, abdominal pain, constipation and fatigue. NDTV reported. Other reported effects include pancreatitis, kidney problems, allergic reactions, and gallbladder problems. Despite these risks, GLP-1 receptor agonists continue to be widely used for weight loss.
The cases included two deaths and one suicide, the agency noted in a March 5 letter and accompanying report. 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 said in a statement that it would “expeditiously and holistically” address concerns flagged by the FDA and added that it was working with the agency to develop an action plan since the inspection in 2025.
Novo vs. Eli Lily
The warning letter comes as Novo is trying to win back patients in the expanding market for obesity drugs, including Ozempic and similar treatments, and is falling behind rival Eli Lilly & Co. The US remains the largest market for these drugs.
The drugmaker’s shares fell about 3.3% in Copenhagen. Since January, shares have fallen nearly 22% through Monday’s close as investors voice concerns about its position in the obesity drug market.
The FDA said the Danish drugmaker has not yet demonstrated how its planned changes would prevent similar violations in the future.
FDA inspection
Bloomberg The report cited the FDA’s inspection report and said the drugmaker discovered in April 2024 that it had failed to properly report serious adverse events related to its blockbuster drug Ozempic and others dating back to 2020. While trying to resolve the issue, an inspection by FDA investigators in 2025 at Novo’s US headquarters in Plainsboro, New Jersey, discovered more than 300 unsubmitted reports, some more than 1,000 days overdue. The cases include at least four deaths and one suicide.
It was also stated that the drugmaker failed to investigate after a doctor reported to a company representative that a patient taking semaglutide Ozempic was depressed and later died by suicide. In another example, Novo was unable to track deaths allegedly because the reporter was not a healthcare professional or the patient’s identity was not disclosed. However, the FDA was able to obtain this important information. The company said it has since reviewed these cases and ensured everything was handled and reported properly.
The FDA also flagged several of Novo’s company procedures as noncompliant; these include a policy that allows potential adverse events to be suppressed if the reporter believes the problem is unrelated to the drug. This is despite the fact that FDA rules require that all serious and unexpected health events be reported.
Separately, the FDA’s recent review found no evidence that GLP-1 drugs like Ozempic increase the risk of suicidal thoughts or behavior. In January, the agency ordered companies to remove warnings about suicide from labels on weight-loss drugs.
How does Ozempic work?
According to a NDTV According to the report, Ozempic enables the pancreas to secrete insulin when a person’s blood sugar is high and helps reduce post-meal glucose levels. It also delays the passage of food from the stomach to the intestines, makes you feel full longer and prevents blood sugar from rising suddenly. GLP-1 receptor agonist also targets the area of the brain that controls hunger and may result in decreased appetite and overall food intake.
