Australia’s TGA Issues Safety Alert On GLP-1 Weight-Loss Drugs Due To Risk Of Psychological Effects

Australia's TGA Issues Safety Alert On GLP-1 Weight-Loss Drugs: The revision of the safety warning comes after an ongoing investigation by Australian and international authorities.

Australia's drug regulator, Therapeutic Goods Administration (TGA), recently issued a safety warning about the usage of GLP-1 weight-loss drugs because of their potential risk of suicidal thoughts and behavioural changes. In a safety alert issued on December 1, the TGA announced that GLP-1 medicines may have a possible risk of mood-related side effects, thus, to ensure consistent guidance.

GLP-1 Weight-Loss Drugs' Psychological Effects

A recent advisory published by the TGA stated that GLP-1 and dual GIP/GLP-1 receptor agonists, which are used to treat type 2 diabetes mellitus or obesity can have certain psychological effects. The revision of the safety warning comes after an ongoing investigation by Australian and international authorities. People who are taking these drugs are urged to immediately report any new or worsening signs of depression, thoughts of self-harm or unusual mood swings.

"Product warnings across the GLP-1 RA class of medicines have been aligned to ensure consistent information regarding the potential risk of suicidal thoughts or behaviours," the TGA stated, "Patients taking any of these medicines should tell their health professional if they experience new or worsening depression, suicidal thoughts or any unusual changes in mood or behaviour."

Mounjaro (Tirzepatide) And Contraception

The regulator further flagged interaction between GLP-1 drug tirzepatide and oral contraceptives. Following their investigation, TGA, in its safety alert, mentioned that the use of Mounjaro (Tirzepatide) may not reduce the effectiveness of oral contraception. However, Australia's drug regulator states that none of the GLP-1 RAs should be used during pregnancy. Individuals of "childbearing potential are advised to use effective contraception during treatment with a GLP-1 RA."

"As a precautionary measure, the product warnings for tirzepatide have been updated to include further advice for patients using oral contraceptives. Patients taking tirzepatide are advised to switch to a non-oral contraceptive or add a barrier method of contraception for 4 weeks after first taking the medicine and for 4 weeks after each increase in the dose," TGA stated.

Risks Of GLP-1 Weight-Loss Drugs

"It is becoming increasingly apparent that in India, many more people are starting to use the newer anti-obesity drugs, particularly those based on GLP-1: Wegovy and Mounjaro. The worrying aspect is that many of them don't qualify for the prescription in accordance with the medical guideline criteria," Dr. Sukhvinder Singh Saggu, GI and Bariatric Surgery at the CK Birla Hospital, Delhi, told Healthsite. "While these medicines can be very powerful if used correctly, we have to remember that they are not without hazards."

Side Effects Of Beyond Psychological Effects

According to the GI and Bariatric Surgery, the initial period of drug use, particularly in the process of increasing dosage, the most common adverse side effects include stomach upset: nausea, vomiting, diarrhea, bloating of the abdomen, feeling full (reduced appetite), and food taking much longer to leave the stomach (delayed gastric emptying).

"Fortunately, many of these problems usually settle with time in most users. Yet, there is always the risk of much more serious complications like pancreatitis, gallstones, severe dehydration, hypotension, or even acute kidney problems," Dr. Saggu said.

"The bottom line is these medications are not for people simply looking for cosmetic weight loss-they are serious treatments. For reasons of patient safety and potential misuse, they absolutely need to be prescribed only by a doctor and used under strict supervision. The doctor needs to carefully check things like the patient's BMI, overall metabolic health, and other health conditions before giving it the green light."