FDA's early review finds no evidence linking Novo, Lilly weight-loss drugs to suicidal thoughts

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来源: FiercePharma

After reviewing data from clinical trials and observational studies, the FDA's preliminary review found no link to GLP-1 medicines and suicidal thoughts.

A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. regulator said.

Over the last several months, the agency has been looking into reports of suicidal thoughts or actions from users of the GLP-1 treatments gathered through its FDA Adverse Event Reporting System (FAERS), it said.

“Because the information provided was often limited and because these events can be influenced by other potential factors, we determined that the information in these reports did not demonstrate a clear relationship with the use of (GLP-1s),” the FDA wrote. The agency said its reviews of clinical trials and observational studies found no association between the treatments and suicidal thoughts.

Ten days ago, the FDA drew attention when it included the trendy therapies on a list of medicines it said it was monitoring for side effects. In the case of Novo’s semaglutide and Lilly’s tirzepatide, those side effects also included alopecia (hair loss) and aspiration, a dangerous condition often associated with surgery in which people breathe food, liquid, vomit or saliva into their lungs.

In Thursday’s FDA update, the agency did not address those other potential side effects.

Also last week, Nature Journal reported that a study of 1.8 million patients in the United States found that those who were using Novo’s drugs such as Ozempic and Wegovy were less likely to have suicidal thoughts compared to patients who were using other diabetes and obesity treatments.

As demand has skyrocketed for the blood sugar-moderating drugs produced by Novo and Lilly, they have come under increased scrutiny. In July of last year, the European Medicines Agency began investigating Ozempic and Wegovy after reports from Iceland detailed suicidal thoughts from two users and self-harm from another. That review is ongoing.

GLP-1 drugs already include label warnings about a rare intestinal blockage condition called ileus, which can be life-threatening.

Through September of last year, the FDA had received 201 reports of suicidal thoughts from users of semaglutide or tirzepatide. In Thursday’s update, the FDA said that it would continue to monitor suicidal ideation in clinical trials and review data from the Sentinel System, a large network that includes health insurance claims and patient records that can be used to investigate safety questions about FDA-approved products.

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