Australia's medicines regulator has issued significant new safety warnings for a popular class of diabetes and weight-loss drugs, flagging potential mental health risks and issues with contraceptive effectiveness.
Mental Health Monitoring Required for GLP-1 Drugs
The Therapeutic Goods Administration (TGA) has mandated that healthcare professionals closely monitor patients using GLP-1 receptor agonist medicines. This action follows reports of suicidal behaviour and suicidal ideation linked to these treatments.
The regulator states that doctors must watch for the emergence or worsening of depression, suicidal thoughts or behaviours, and any unusual changes in mood in individuals prescribed these drugs. This precautionary warning applies to the entire class of GLP-1 RA medicines, which includes well-known brands such as Ozempic, Wegovy, Saxenda, Trulicity, and Mounjaro.
Separate Contraception Warning for Mounjaro
In a separate safety communication, the TGA has also addressed concerns regarding the drug Mounjaro (tirzepatide) and its potential interaction with oral contraceptives. An investigation concluded that the agency could not rule out an association between starting Mounjaro or increasing its dose and a reduction in the effectiveness of hormonal birth control pills.
As a result, the TGA has updated the product information for Mounjaro with specific, precautionary advice for patients:
- Patients using oral contraceptives are advised to switch to a non-oral method, such as an implant or intrauterine device (IUD).
- Alternatively, they should add a barrier method of contraception, like condoms.
- This additional protection is recommended for four weeks after first starting the medication and for four weeks after each subsequent dose increase.
Key Precautions and Broader Advice
The TGA reinforces that none of the GLP-1 RA class of medicines should be used during pregnancy. This aligns with existing guidance for many medications where risks to a developing foetus are not fully known.
These warnings highlight the importance of ongoing safety monitoring for newer pharmaceutical treatments, even after they have been approved for use. Patients currently using or considering these drugs for weight management or diabetes are urged to discuss these new warnings with their prescribing doctor. Healthcare providers are expected to weigh the significant benefits of these medications against the potential risks for each individual patient.
The TGA's actions serve as a critical reminder for both prescribers and patients to remain vigilant about side effects and to maintain open communication regarding any changes in physical or mental health while on treatment.
