MHRA Review Finds No Link Between GLP-1 Receptor Agonists and Suicidal Behaviour or Depression
The MHRA has concluded that there is no evidence to support a link between GLP-1 receptor agonists and an increased risk of suicidal behaviour, self-harm, or depression, following a comprehensive review of clinical and post-marketing data.
Introduction
Following a thorough evaluation, the MHRA has found no evidence to support a link between GLP-1 receptor agonists and suicidal behaviour, self-harm, or depression. The review concludes that no updates to product safety information are required at this time.
Overview
The Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that there is no evidence to support a causal link between Glucagon-Like Peptide-1 (GLP-1) receptor agonists and an increased risk of suicidal thoughts, self-harm, or depression. Following a comprehensive review of post-marketing data and clinical trial evidence, the MHRA’s findings align with those from a European regulatory review.
Background
In July 2023, concerns were raised regarding the potential psychiatric risks associated with GLP-1 receptor agonists, including exenatide, lixisenatide, liraglutide, dulaglutide, and semaglutide. These drugs, commonly used to treat type 2 diabetes and obesity, were under review after post-marketing reports suggested a possible association with suicidal ideation, self-harm, and depression.
In response, the MHRA and European regulators initiated a detailed evaluation of data from multiple sources, including:
• Post-marketing surveillance reports
• Clinical trial outcomes
• Epidemiological studies
• Scientific literature
Key Findings
After reviewing the available data, the MHRA concluded:
• There is no causal link between GLP-1 receptor agonists and suicidal behaviour, suicidal ideation, self-harm, or depression.
• No updates to product information are necessary at this time.
However, the MHRA will continue to monitor for any potential psychiatric side effects associated with these drugs and assess new data as it emerges.
About GLP-1 Receptor Agonists
GLP-1 receptor agonists are primarily prescribed for managing type 2 diabetes and obesity. They work by mimicking the action of the GLP-1 hormone to:
• Stimulate insulin secretion
• Reduce glucagon secretion
• Slow gastric emptying
• Promote satiety, aiding in weight management
These medications can be used alone or with other diabetes treatments, and some are approved for weight management in patients with a BMI greater than 30 kg/m² or those overweight with a BMI over 27 kg/m².
Future Monitoring
Whilst the current evidence does not support a risk of severe psychiatric reactions, the MHRA will remain vigilant, continually reviewing data from new reports and studies to ensure patient safety.
For more information, the European regulatory review findings are available online.
Conclusion
Patients and healthcare professionals can be reassured that there is no established link between GLP-1 receptor agonists and suicidal behaviour or depression based on current evidence. Ongoing surveillance will ensure that any emerging risks are promptly addressed. This update reinforces the safety of these medications, which play a vital role in managing diabetes and obesity.
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