Danish drugmaker Novo Nordisk is now in focus and is dealing with scrutiny from the US Meals and Drug Administration (FDA). On Tuesday (native time) stated that it acquired a warning letter from the FDA for failing to report all suspected unwanted effects skilled by sufferers utilizing Ozempic, Bloomberg reported.
Nausea, vomiting, diarrhea, stomach ache, constipation, and fatigue are recognized unwanted effects of Ozempic, the diabetes drug now broadly used for weight administration, NDTV reported. Different reported results embody pancreatitis, kidney issues, allergic reactions, and gallbladder points. Regardless of these dangers, GLP-1 receptor agonists proceed to be broadly used for weight reduction.
The company famous in a letter dated March 5 and its accompanying report that the instances concerned two deaths and one suicide. Nevertheless, the FDA didn’t specify whether or not these deaths or different reported unwanted effects have been straight linked to Ozempic.
Will tackle FDA’s considerations: Novo
The drugmaker, in an announcement, stated it’ll tackle the considerations flagged by the FDA “expeditiously and holistically,” including that it has been working with the company to develop an motion plan since an inspection in 2025.
New vs Eli Lily
The warning letter arrives as Novo struggles to regain sufferers within the increasing weight problems drug market, together with Ozempic and related remedies, the place it has fallen behind competitor Eli Lilly & Co. The US stays the biggest marketplace for these medicines.
The drugmaker’s shares declined almost 3.3% in Copenhagen. Since January, the shares have declined almost 22% via Monday’s shut as buyers flagged considerations over its place within the weight problems drug market.
The FDA stated that the Danish drugmaker has but to display how its deliberate adjustments will forestall related violations sooner or later.
FDA inspection
The Bloomberg report cited the FDA’s inspection report and stated that in April 2024, the drugmaker found that it had did not correctly report severe adversarial occasions involving its blockbuster drug Ozempic and others relationship again to 2020. Whereas it tried to handle the problem, an inspection by FDA investigators in 2025 at Novo’s US headquarters in Plainsboro, New Jersey, found over 300 unsubmitted studies, some delayed by over 1,000 days. The instances included no less than 4 deaths and a suicide.
It additional stated that the drugmaker didn’t probe when a physician knowledgeable the corporate consultant {that a} affected person taking Ozempic, the semaglutide, was depressed and died by suicide later. In one other occasion, Novo additionally did not observe up on deaths, allegedly as a result of the reporter was not a well being skilled or as a result of the affected person’s identification was not revealed. Nevertheless, the FDA was in a position to receive this important info. The corporate has stated that since then, it has reviewed these instances and ensured that all the things was processed correctly and reported.
The FDA has additionally flagged Novo’s a number of firm procedures as noncompliant, which embody a coverage that allowed potential adversarial occasions to be withheld if the reporter believed the problem was unrelated to the drug. That is even though FDA guidelines require all severe and surprising well being occasions to be reported.
Individually, the FDA’s current evaluation discovered no proof that GLP-1 medicine resembling Ozempic enhance the danger of suicidal ideas or behaviors. In January, the company instructed corporations to take away suicide-related warnings from weight-loss drug labels.
How does Ozempic work?
Based on an NDTV report, Ozempic prompts the pancreas to launch insulin when an individual’s blood sugar is excessive, and helps in decreasing post-meal glucose ranges. Moreover, it delays the motion of meals from the abdomen to the intestines, selling longer-lasting fullness and stopping blood sugar spikes. The GLP-1 receptor agonist additionally targets the area of the mind that controls starvation, and may end up in lowered cravings and total meals consumption.