HQ Team
December 2, 2023: The European Medicines Agency (EMA) is intensifying its investigation into the potential link between certain GLP-1 receptor agonist drugs used for diabetes and weight loss and reported cases of suicidal thoughts and self-harm among patients.
This move follows a recent safety signal and the issuance of questions to major drug manufacturers, including Novo Nordisk, Eli Lilly, Amylin Pharmaceuticals, AstraZeneca, and Sanofi.
EMA’s review
The EMA, Europe’s drug watchdog, announced on December 1 that it will request additional data from makers of GLP-1 drugs, such as Novo Nordisk’s Ozempic and Wegovy, to delve deeper into the reported instances of suicidal thoughts among patients using these medications. The review, initiated in July, covered a spectrum of GLP-1 receptor agonists, including Eli Lilly’s Trulicity, Sanofi’s Suliqua, and Novo’s Saxenda.
The European Medicines Agency (EMA) said in a statement that “while at this point no conclusion can be drawn on a causal association, there are several issues that still need to be clarified.”
The agency added that the review had been triggered by the Icelandic medicines agency following reports of suicidal thoughts and self-injury in people using the drugs. In the November statement, the EMA added that authorities were looking into 150 possible cases of self-injury and suicidal thoughts.
FDA’s involvement
The global concern over the safety of GLP-1 drugs extends beyond Europe, with the U.S. Food and Drug Administration (FDA) reporting 265 cases of suicidal thoughts or behavior in patients taking GLP-1 medications between 2010 and June 2023. The FDA is currently reviewing these reports to determine the necessary course of action.
Previous concerns
This recent safety signal isn’t the first for GLP-1 drugs. Over the summer, the EMA raised concerns about a potential link between GLP-1s and thyroid cancer. This worry originated from a study suggesting an increased risk of thyroid cancers in patients with type 2 diabetes using these medicines. The safety signal included drugs from Novo Nordisk, Lilly, Sanofi, and AstraZeneca.
EMA’s safety committee has posed questions to Novo Nordisk, Eli Lilly, Amylin Pharmaceuticals, AstraZeneca, and Sanofi regarding the reported cases of suicidal thoughts. The manufacturers will collaborate with authorities to investigate and address any concerns related to patient safety. The EMA’s risk assessment committee, responsible for monitoring drug side effects, plans to revisit the topic in April 2024.
As the EMA deepens its scrutiny into the potential link between GLP-1 drugs and suicidal thoughts, the pharmaceutical industry faces a critical juncture. Patient safety remains a top priority for manufacturers, but the ongoing investigations underscore the need for a thorough understanding of any potential risks associated with these widely used diabetes and weight loss medications.
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