Articles

We have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.

We have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.

Updates further highlight potential risks of mood-related changes and sexual disorders.

More prominent warnings are being added to the product information (PI) and consumer medicine information (CMI) for all oral and injectable (systemic) fluoroquinolones to strengthen existing warnings about serious side effects

We are updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI)

Additional safety information is being added to all montelukast products to strengthen and highlight existing warnings about serious neuropsychiatric events.

Recall reforms program update and preview of the PRAC Version 1.0.

TCMs sold in Australia are carefully regulated to ensure safety and quality.

Health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under 6 years of age.

Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.

An updated warning about the risk of sudden cardiovascular death has been added to the Product Information and Consumer Medicine Information documents for azithromycin.

The TGA reminds businesses and media outlets that it is unlawful to publicly advertise prescription-only medicines, including prescription-only weight loss medicines.

We have accepted an enforceable undertaking from 2San Pty Ltd in relation to breaches of the Therapeutic Goods Act 1989. This relates to the company's unlawful import and supply of medical devices.

The company imported medical devices not included in the Australian Register of Therapeutic Goods. They supplied these devices to a national retailer, who then sold them to the public.

Amendments to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6) have been made resulting in compounded GLP-1 RA products no longer being able to be compounded by pharmacists and supplied to patients.

Some online health clinics are advertising and selling compounded medicines. However, it is important to know that compounded products are not identical to TGA approved products.

The Product Information documents for antidepressants have been updated with warnings about sexual dysfunction continuing in some patients, after they stop using the medicines.

We are aware that a small number of people have received calls from scammers impersonating the TGA.

Medicines Safety Update - Information for health professionals

To help sponsors and manufacturers transition to new manufacturer evidence.

Transition period for accepting ISO 13485 ends 26 May 2023.

The TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).

The TGA is aware of several scams targeting consumers seeking semaglutide (Ozempic). Consumers are strongly advised not to use products unless they have come from a trusted source.

Supplies of Ozempic (semaglutide) have begun distribution in Australia but will remain quite limited for some time.

Before you take a weight loss supplement or medicine, there are things to consider.