Watchdog Updates Safety Warnings on Ozempic-Like Drugs Over Suicidal Thoughts Risk

Regulatory Update on Ozempic-Style Drugs and Mental Health Risks

Australia’s Therapeutic Goods Administration (TGA) has issued an updated safety warning regarding Ozempic-style drugs, highlighting potential risks of suicidal thoughts and behaviors. The agency emphasized the importance of informing healthcare providers immediately if patients experience new or worsening depression, suicidal ideation, or unusual mood changes while using these medications.

The warning applies to GLP-1 receptor agonists, a class of drugs initially developed to treat type 2 diabetes but now widely used for obesity management. The TGA identified affected medications as Ozempic (semaglutide), Wegovy (semaglutide), Saxenda (liraglutide), Trulicity (dulaglutide), and Mounjaro (tirzepatide). These drugs mimic a natural hormone to slow digestion and promote fullness.

Evidence and Investigations

TGA’s alert follows investigations conducted both domestically and internationally. While the regulator stated the current evidence does not conclusively prove that GLP-1 drugs cause suicidal thoughts, it acknowledged a complex interplay between mental illness, conditions treated by these drugs, and possible associations with substantial weight loss. The TGA received 72 reports of suicidal ideation and about a dozen related to suicide attempts or deaths among users.

International studies on the psychiatric effects of GLP-1 medications are mixed. Some found no significant links, but a study published in Scientific Reports noted increased risks of depression, anxiety, and suicidality, possibly due to drug-induced alterations in brain dopamine levels. Similarly, the U.S. Food and Drug Administration (FDA) continues to monitor reports but has not found definitive proof of causation.

Additional Safety Advice for Patients

The TGA also cautioned about tirzepatide (Mounjaro), noting a potential reduction in oral contraceptive effectiveness. Patients starting or increasing tirzepatide doses are advised to use alternative or additional contraceptive methods for at least four weeks. Moreover, the regulator underscored that no GLP-1 drug should be taken during pregnancy.

Key Points for Patients and Healthcare Providers

1. Monitor any new or worsening symptoms related to mood or behavior.
2. Report concerns promptly to healthcare professionals.
3. Apply additional contraception methods when using tirzepatide.
4. Avoid GLP-1 drugs during pregnancy.
5. Recognize the complexities linking medication, mental health, and weight loss.

The TGA continues to encourage vigilance and balanced risk communication, aiming to harmonize safety information across all GLP-1 medications without implying direct causation. Patients and clinicians should maintain open dialogue to ensure safe and informed use of these drugs.