LONDON — Following a nine-month investigation, European regulators stated Friday they’ve discovered no proof that GLP-1 medication like Ozempic and Wegovy trigger suicidal ideas or actions.
The announcement from the European Medicines Company echoes the findings of a evaluation by the U.S. Meals and Drug Administration, which in January stated it didn’t discover a causal relationship between the category of weight reduction and diabetes drugs and suicidal ideation.
The EMA’s evaluation began final July following anecdotal stories of sufferers experiencing ideas of self-harm whereas on liraglutide (a branded model is Novo Nordisk’s Saxenda) and semaglutide (Novo’s Ozempic and Wegovy). In November, the EMA’s Pharmacovigilance Danger Evaluation Committee requested extra particulars from the makers of numerous GLP-1 medication.
As a part of their evaluation, the committee analyzed medical data, scientific trials, post-marketing surveillance knowledge, and different research, together with a current Nature Medication paper that discovered that there was a decrease danger of suicidal ideation linked to GLP-1 medication than for different weight problems and diabetes therapies. Total, the committee stated that the outcomes of their analysis “didn’t help a causal affiliation between the usage of GLP-1 receptor agonists and this danger” of suicidal ideation.
The EMA stated that GLP-1 makers are required to proceed to watch for any occasions of suicidal ideas or actions going ahead.
GLP-1-based medication like Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound have exploded in reputation lately. As extra sufferers began taking the medication, nevertheless, there have been numerous anecdotal stories of suicidal ideation, resulting in the investigations.
In its January assertion, which was based mostly on a preliminary evaluation, the FDA stated it couldn’t definitively rule out {that a} small danger of suicidal ideas and actions might exist. It stated it was persevering with to analyze.
Earlier weight problems therapies have been dogged by fears of psychiatric dangers. For instance, rimonabant was pulled off European markets in 2008 as a result of considerations that it raised the danger of suicidal ideas.
The FDA labels for Wegovy and Zepbound, that are accredited for weight problems, already warn docs to watch sufferers for suicidal ideas, whereas the labels for Ozempic and Mounjaro, that are accredited for sort 2 diabetes, don’t comprise that warning.
