MHRA review finds no evidence linking GLP-1 receptor agonists to suicidal thoughts

GLP-1 receptor agonists are used to treat type 2 diabetes and obesity

Following a comprehensive review, the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that current evidence does not support a causal link between Glucagon-Like Peptide-1 (GLP-1) receptor agonists and suicidal behaviour, suicidal ideation, self-injury, or depression.

GLP-1 receptor agonists , which contain active ingredients such as exenatide, lixisenatide, liraglutide, dulaglutide, and semaglutide, are commonly used to treat type 2 diabetes and obesity.

In July 2023, concerns were raised about the safety of these receptor agonists after post-marketing reports suggested a potential risk of suicidal thoughts and self-harm associated with these medications.

As a result, safety reviews were initiated by the Market Authorisation Holders (MAHs), evaluating the UK post-marketing data to assess the potential risks of these drugs.

These reviews also examined the risk of depression in the interest of patient safety following reports of these side effects.

The MHRA’s findings aligned with the conclusions of a broader European regulatory review that analysed the data from several sources, including post-marketing reports, clinical trials, epidemiological studies and scientific literature.

“We conclude that the available data does not support a causal association between GLP-1 receptor agonists and suicide, suicidal ideation, self-injury and depression, and therefore no updates to the product information is warranted at this time,” the MHRA said.

However, the MHRA noted that it will continue monitoring these medications for severe psychiatric reactions, assessing any new data as it becomes available to ensure patient safety.

GLP-1 receptor agonists, including Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide), are used for weight loss and for treating type 2 diabetes.

They work by mimicking the action of the natural hormone GLP-1, which helps regulate blood sugar levels by stimulating insulin secretion, reducing glucagon secretion, slowing gastric emptying, and promoting satiety.

GLP-1 receptor agonists can be used alone or in combination with other diabetes medications.

Some of these medications including Saxenda and Wegovy have been approved for weight management, together with diet and physical activity, in people who are obese (BMI greater than 30 kg/m²) or overweight (BMI of 27 kg/m).

In July, the MHRA also approved the use of Wegovy for reducing the risk of serious heart problems and strokes in adults who are obese or overweight.

Earlier this year, the Department of Health and Social Care (DHSC) announced a shortage of GLP-1 receptor agonists for treating type 2 diabetes, attributing the supply issues to “an increase in demand for these products for licensed and off-label indications.”

Ozempic, which is authorised for treating adults with insufficiently controlled type 2 diabetes alongside diet and exercise, has been frequently used off-label for weight loss.

The MHRA indicated that supply levels are unlikely to return to normal before the end of 2024.