The Food and Drug Administration sent a warning letter to the makers of Ozempic and Wegovy for not reporting potential side effects of the drugs.

The agency told Novo Nordisk it had “serious violations” connected to semaglutide, the active ingredient in the medications, NBC News reported.

The FDA said there were three deaths of patients who were using the GLP-1 medications. One died by suicide, The Hill reported. The FDA did not say that the medication caused the deaths or side effects.

The federal agency said the company did not tell the FDA about the deaths in the required time frame and that Novo Nordisk did not investigate or report the suicide.

The FDA had recently determined that there was no connection between GLP-1s and suicide, CBS News reported. It had requested in January to remove warnings about suicidal behavior or ideation from the treatments.

Novo Nordisk had 15 days to report adverse reactions to the medications, The Hill reported.

One case involved someone who had a stroke while taking GLP-1 liraglutide.

“The consumer reported the stroke was not related to liraglutide, therefore you rejected this case. As a result, you failed to report serious and unexpected [adverse drug events] to FDA within 15 calendar days as required by [Postmarketing Adverse Drug Experience] regulations,” the FDA told Novo Nordisk, according to The Hill.

The FDA gave Novo Nordisk two weeks to tell them of the steps the company will take to prevent violations.

The company released a statement online that said it was working “diligently” to address the agency’s concerns.

“Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” the company wrote.

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