EMA Requests More Data from GLP-1 Drugmakers in Suicidal Ideation, Self-Harm Probe

EMA_Niels Wenstedt/BSR Agency/Getty

Niels Wenstedt/BSR Agency/Getty Images

The European Medicines Agency is asking the marketing authorization holders for several GLP-1 drugs for “further clarifications” as part of its ongoing review of the potential risk of suicide and self-harm thoughts, the EU watchdog announced on Friday.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said it had reviewed clinical trials, post-marketing surveillance and published literature on the reported cases of self-harm and suicidal thoughts. While the statement noted that “no conclusion can be drawn” on any causal association of these thoughts and GLP-1s, the PRAC emphasized that “several issues” still need to be clarified.

The committee said the marketing authorization holders of multiple GLP-1s must address further lists of questions. The drugs named by the committee for the query include: Novo Nordisk’s Ozempic, Rybelsus, Saxenda, Xultophy, Victoza, Wegovy and Victoza, as well as Eli Lilly’s Trulicity and Byetta, AstraZeneca’s Bydureon, and Sanofi’s Lyxumia and Suliqua. Saxenda’s label has a warning for “suicidal behavior and ideation.”

The PRAC plans to rediscuss the topic at a meeting in April 2024 and the EMA will provide more information when it becomes available.

The EMA’s GLP-1 probe for possible risks of suicidal ideation and self-harm thoughts has been ongoing since July2023. That same month, the agency extended its review of potential risks  for Ozempic and Saxenda to other GLP-1s. The initial review was triggered by the Icelandic Medicines Agency following reports of suicidal thoughts and self-injury in people using liraglutide and semaglutide.. At the time, the EMA said it was analyzing around 150 reports of cases of suicidal and self-harm thoughts.

Soon after the EMA launched its review, the UK also initiated its own investigation. In late July 2023, the U.K.’s Medicine and Healthcare Product Regulatory Agency said it had received five reports of adverse reactions, including self-injury and suicidal behaviors for patients on semaglutide. Another 12 reports of self-harm and suicidal thoughts were recorded for liraglutide patients.

However, thoughts of suicide or self-harm are not the only potentially adverse effects of the blockbuster drugs. In October 2023, a study published in the medical journal JAMA reported a risk associated with gastrointestinal adverse effects and GLP-1s. A Louisiana woman is also suing Novo Nordisk and Eli Lilly, alleging that both companies failed to warn its users about the risk of gastrointestinal issues for Mounjaro and Ozempic—including risks for gastroparesis and gastroenteritis.

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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