Safety Update on GLP-1 RA medications such as Ozempic – what you need to know?

Why is there a safety update? 

The Therapeutic Goods Administration (TGA) have identified two important safety concerns linked with these medicines: 

1. Potential risk of suicidal thoughts 

If you are taking any of these medicines you should tell your health professional if you experience: 

• New or worsening depression 
• Suicidal thoughts 
• Unusual or concerning changes in mood or behaviour 

These symptoms do not happen to everyone, but it is important to be aware of them. 

The following things can increase your risk of the above changes: 

• Losing weight too fast, that is more than 1kg per week   
• Strict dieting  
  • This has been shown to can cause tiredness, irritability, and sadness. 
• Expecting big life changes after weight loss 
  • If these big life changes do not occur this can lead to disappointment and other changes mentioned above. 
• Low body image or self esteem
  • Some people may still feel unhappy with their body or self-esteem after weight loss. 
  • Living with an existing eating disorder or undiagnosed eating 

Important Information for people taking Semaglutide 

• Some studies have shown that semaglutide (Ozempic and Wegovy) may be linked to a higher chance of feeling depressed, anxious, or having thoughts of self-harm. This could be because the medication might change the levels of dopamine, a chemical in the brain that helps control mood and motivation. 
• Whilst cases are rare, research shows that people on semaglutide reported suicidal thoughts more often than those taking other medications.
• Research has shown that this was still 45% higher than for other medicines in the database.  

2. Mounjaro (tirzepatide) and contraception 

If you are taking Mounjaro (tirzepatide) and you also use the oral contraceptive pill, there is a chance that the pill may not work as well when you first start Mounjaro or when your dose is increased. We cannot rule out this effect.

Because of this, the safety information for Mounjaro has been updated. 

Important: 

• GLP-1 medicines, including Mounjaro, should not be used during pregnancy. 
• If there is any chance you could become pregnant, you should use effective contraception while taking these medicines. 

If you have questions about contraception or your treatment, talk to your doctor, pharmacist, or nurse. 

 The rest of this article will focus on the first safety warning - Potential risk of suicidal thoughts. 

What does this mean for me? 

If you are taking one of these medications, contact your doctor or healthcare provider straight away if you notice: 

• Feeling unusually sad, hopeless, or down 
• Thoughts about harming yourself 
• Feeling more anxious, irritable, or emotionally unstable 
• Any behaviour that feels out of character for you 

Do not stop your medication suddenly without speaking to a healthcare professional, unless you feel unsafe. 

If you need urgent help 

If you or someone you know is in immediate danger or cannot stay safe, call: 

• 000 
• Lifeline: 13 11 14 
• Beyond Blue: 1300 22 4636 
• CAT Team: Victoria (General Psychiatric Triage): 1300 363 746 (24 hours) 

Why can these changes occur? 

There is a complex link between: 

• Diabetes  
• Significant weight loss; and 
• Mental health conditions, such as depression or anxiety 

Having all of the above may lead to emotional or psychological effects that a person may or may not have experienced before. 

Are these medicines still safe to use? 

For most people, GLP-1 RA medications remain safe and effective. Your doctor has prescribed them because the benefits for your health outweigh the known risks. The new safety advice simply encourages closer monitoring, especially if you have a history of mental health concerns. It is important to link in with your GP or Diabetes Educator/Dietitian if you are on any of these medications. 

More information is available on the TGA website.

Reduce your risk

Tips to help reduce your risk of suicidal thoughts and mood changes whilst on these medications: 

It is important that your prescribing doctor assesses you prior to going on these medications to see if they are right for you. Your prescribing doctor should: 

• Complete a mental health assessment: 
  • before starting with a GLP-1 RA; and  
  • at regular intervals.  
• Discuss with you why you would like to start on a GLP1 RA medication and what your expectations are.
  • This is to ensure you have realistic expectations about being medications. 

If your prescribing doctor hasn’t completed the above, please book an appointment to discuss if the medication is still right for you.   

Please also book an appointment with your prescribing doctor if: 

• you are experiencing any of the mood, behaviour or thought changes above; and/or 
• you have any other health conditions that you may not have discussed with your GP that may increase your risk such as an eating disorder, anxiety, depression. 

Other tips include: 

• Aim for a steady weight loss of no more than 0.5 to 1kg per week 
• Eat a healthy balanced diet 
  • For more information read this information sheet - Healthy food choices fact sheet  
• Focus on the benefits to your health and how you feel, not just how much weight you have lost. 
• Speak to a healthcare professional if you notice any of the following: 
  • Feeling unusually sad, hopeless, or down 
  • Thoughts about harming yourself 
  • Feeling more anxious, irritable, or emotionally unstable 
  • Any behaviour that feels out of character for you 

• If you or someone you know is in immediate danger or cannot stay safe, call: 
  • 000 
  • Lifeline: 13 11 14 
  • Beyond Blue: 1300 22 4636 
  • CAT Team: Victoria (General Psychiatric Triage): 1300 363 746 (24 hours) 

For more information and support: 

• Speak with your prescribing doctor 
• Watch for FREE the Diabetes Care Plus Clinic webinar on GLP1 RAs 
• Book an appointment at the Diabetes Care Plus Clinic with our Dietitians and Diabetes Educators.  They are skilled to support you in taking these medications. 
  • To or find out more about our Clinic please visit the website or call 1300 153 123.