TGA issues new warning for weight-loss, diabetes jabs

The TGA launched an investigation into two different side effects after receiving multiple reports. See the new warnings.

Patients on popular GLP-1 weight-loss and diabetes jabs should be monitored for suicidal behaviour, the TGA says, while Mounjaro may stop the birth control pill from working.

The warnings, released on Monday, come after the Therapeutic Goods Administration investigated international reports of a link between GLP-1 medications and suicide, along with Mounjaro and unintended pregnancies.

The Advisory Committee on Medicines, consulted by the TGA as part of this investigation, found there was insufficient evidence to prove the drugs were causing suicidal ideation.

But it also advised the inconsistent information across the various drugs should be updated to reflect the “awareness” of the potential risk of suicidal thoughts or behaviours.

The TGA said patients taking Ozempic, Wegovy, Saxenda, Trulicity or Mounjaro should be monitored for “the emergence or worsening of depression, suicidal thoughts or behaviours and/or any unusual changes in mood or behaviour”.

Doctors have been asked to carefully consider the “benefits and risks” of the drugs for patients with “a history of suicidal attempts”.

The TGA investigated reports of a link between suicidal ideation and GLP-1 drugs like Ozempic. Picture: Getty

The TGA’s other investigation, into Mounjaro’s impact on oral contraception, found an association between the weight-loss drug and “reduced effectiveness” of the pill “could not be ruled out”.

Patients on Mounjaro who use the birth control pill have been advised to use a different contraceptive method for four weeks after starting the drug, or increasing their dose.

The TGA also reiterated that the drug should not be used during pregnancy.

The TGA’s Database of Adverse Event Notifications, which allows Australian clinicians or patients to report suspected side effects, has received 72 reports for suicidal ideation, and two cases of suicide, for the drug.

There was a further six reports for depressional suicidal, four suicide attempts and one report of self-harming ideation.

Mounjaro patients should not rely on oral contraceptives when starting the weight-loss drug, or increasing their dose.

The database recorded one case of a pregnancy on oral contraceptives for Mounjaro, and one more for semaglutide, the active drug in Ozempic and Wegovy.

A report to the database, which anyone can file, is not proof an adverse event — only suspicion — and is not intended as source of verified cases.

But it’s monitored by the TGA for unusual or unexpected patterns to investigate further.

GLP-1 drugs have exploded in popularity in recent years, leading to mass global shortages as manufacturers struggled to keep up with the rising demand for the prescription only diabetes and weight-loss drugs.

The TGA said it “will continue to monitor the safety of GLP-1 RA medicines and will take appropriate regulatory action to address safety concerns when they are identified”.

Originally published as TGA issues new warning for weight-loss, diabetes jabs