The U.S. Food and Drug Administration sent a warning letter this month to Novo Nordisk, the maker of Ozempic and Wegovy, alleging the drugmaker failed to report potential side effects in patients who took the popular GLP-1 medications in a timely manner.The medications are prescribed for diabetes and weight loss.Related video at the top: What to know about weight-loss scams In the March 5 warning letter, the FDA noted that it observed “serious violations” when a Post-marketing Adverse Drug Experience inspection was conducted at Novo Nordisk’s New Jersey site early last year.The letter specifically cited three deaths among patients who took semaglutide, which is the generic name for the active ingredient in Ozempic and Wegovy. One of those deaths included a person who died by suicide, according to the letter. It should be noted that the FDA did not say whether the deaths or adverse side effects were specifically caused by the drugs.The pharmaceutical giant didn’t report the deaths to the agency within the FDA’s required timeframe, according to the letter.In a statement released March 10, Novo Nordisk said it initially received inspectional observations from the FDA in February 2025, and that it “has been working diligently to address those observations ever since.”In the statement on Tuesday, the drugmaker acknowledged it received the warning letter and that it “welcomes further dialogue with the US FDA.” The company said it is “working diligently” to address the concerns of the FDA.The drugmaker noted that the FDA’s warning letter acknowledges the “significant measures Novo Nordisk has taken over the past year meant to ensure full compliance” with reporting requirements. “The Warning Letter largely seeks additional details on these measures to confirm current and future regulatory compliance; it does not make any conclusions about the quality or safety of our medicines,” the company said.Novo Nordisk said it does not expect the situation to impact production.

The U.S. Food and Drug Administration sent a warning letter this month to Novo Nordisk, the maker of Ozempic and Wegovy, alleging the drugmaker failed to report potential side effects in patients who took the popular GLP-1 medications in a timely manner.

The medications are prescribed for diabetes and weight loss.

Related video at the top: What to know about weight-loss scams

In the March 5 warning letter, the FDA noted that it observed “serious violations” when a Post-marketing Adverse Drug Experience inspection was conducted at Novo Nordisk’s New Jersey site early last year.

The letter specifically cited three deaths among patients who took semaglutide, which is the generic name for the active ingredient in Ozempic and Wegovy. One of those deaths included a person who died by suicide, according to the letter.

It should be noted that the FDA did not say whether the deaths or adverse side effects were specifically caused by the drugs.

The pharmaceutical giant didn’t report the deaths to the agency within the FDA’s required timeframe, according to the letter.

In a statement released March 10, Novo Nordisk said it initially received inspectional observations from the FDA in February 2025, and that it “has been working diligently to address those observations ever since.”

In the statement on Tuesday, the drugmaker acknowledged it received the warning letter and that it “welcomes further dialogue with the US FDA.” The company said it is “working diligently” to address the concerns of the FDA.

The drugmaker noted that the FDA’s warning letter acknowledges the “significant measures Novo Nordisk has taken over the past year meant to ensure full compliance” with reporting requirements.

“The Warning Letter largely seeks additional details on these measures to confirm current and future regulatory compliance; it does not make any conclusions about the quality or safety of our medicines,” the company said.

Novo Nordisk said it does not expect the situation to impact production.