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European regulator concludes no suicide link to obesity drugs

Dive Brief:

  • Novo Nordisk and Eli Lilly drugs to treat diabetes and obesity have no “causal association” with suicidal thoughts or incidents of suicide or self-harm, Europe’s health regulator said Friday after a review of health records.

  • As a result, the companies won’t be required to change the labeling for GLP-1 drugs like Ozempic and Trulicity to warn physicians about the risk of suicidal thoughts, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee said after a four-day meeting this week.

  • The examination of suicidal risk has spanned both sides of the Atlantic over the past nine months, triggered by a report of several cases involving suicide “ideation” or self-harm among people taking Novo’s GLP-1 drugs Saxenda and Ozempic from Iceland’s drug regulator. The Food and Drug Administration closed its probe earlier this year.

Dive Insight:

The EMA’s review clears a concern that had hung over the class since the first reports about suicide ideation emerged last July. GLP-1s and related hormone-modulating drugs affecting metabolism are forecast to have sales of $158 billion a year by 2032, according to analysts from Leerink Partners, but that growth could have been slowed by any finding they increase the risk of suicide.

GLP-1 drug labels already carry warnings about the risk of a certain type of thyroid tumor, and the class has previously been scrutinized for pancreatic cancer risk because they can lead to inflammation of the pancreas.

The EMA’s pharmacovigilance committee examined the possibility of a suicide risk several ways. They looked at large databases of health records from patients taking Ozempic and Wegovy for diabetes or weight loss, and then a second database of health records from patients taking a wider variety of GLP-1s for diabetes. In addition, they examined data from clinical trials of GLP-1s, as well as post-marketing surveillance data.

Angela Fitch, president of the Obesity Medicine Association, called the finding “positive, and what we all have seen clinically.”

“We will continue to monitor the mental state of our patients as people with obesity, and those undergoing treatment for obesity, have a higher prevalence of mood disorders at baseline,” Fitch, chief medical officer at obesity treatment clinic Knownwell, said in a statement.

Novo’s GLP-1 drugs for diabetes and obesity had combined sales of $24 billion in 2023, while Lilly’s had combined sales of $12 billion.