When new safety information for medicines is identified, the Therapeutic Goods Administration (TGA) works with the sponsors to update Product Information (PI) to ensure that health professionals and consumers have access to this information. New safety information can be identified through the TGA’s ongoing safety monitoring activities or uncovered and submitted by sponsors themselves. Please see below details of some medicines that have recently had safety related updates to their PI.
The TGA monitors the safety of medicines marketed in Australia using:
- reports of adverse events
- Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs)
- reviews of literature
- sharing of information with other regulatory agencies
- sharing of information with Australian state and territory health authorities.
Changes to the PI that result from TGA safety monitoring activities may:
- narrow indications
- add or modify specific sections, such as:
- contraindications
- warnings or precautions
- use in fertility, pregnancy and lactation
- use in special populations
- adverse effects.
It is important for prescribers and other health professionals to be aware of safety-related PI changes, as they may require you to take actions or do things differently, such as:
- counsel patients on identified risks
- undertake special monitoring or precautions
- in some instances select alternate medications.
Significant PI changes are often supported by distribution of a Dear Health Care Professional Letter on the issue, which are produced by the medicine’s sponsor and sent directly to health professionals.
We will publish a Medicines Safety Update (MSU) article detailing recent safety-related PI updates each month, although this may not include all safety-related updates. We will continue to publish MSU articles for critical safety issues or topics of special interest.
The below medicines are generally innovator brands (generic brands may be included in some circumstances). Generic brands containing the same active ingredients as the medicines below are required to align with the safety information in the innovator’s PI and will be updated accordingly.
To view the full PI for each listing, click on the name of the product in the ‘Brand/trade name’ column. A ‘Summary table of changes’ appears at the end of the PI. If the TGA has published any further risk communication, such as a safety alert or stand-alone MSU article, it will be linked to in the ‘Safety issue’ column.
Active ingredients | Brand name Sponsor | PI updates | Date of approval |
|---|---|---|---|
arsenic trioxide | Phebra Pty Ltd | 4.3 – Contraindications
4.6 – Fertility, pregnancy and lactation
| 23 August 2023 |
citalopram hydrobromide | Lundbeck Australia Pty Ltd | 4.4 – Special warnings and precautions for use
| 23 August 2023 |
darolutamide | Bayer Australia Ltd | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 23 August 2023 |
denosumab | Amgen Australia Pty Ltd | 4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects)
| 30 August 2023 |
durvalumab | Aspen Pharmacare Australia Pty Ltd |
4.4 – Special warnings and precautions for use
| 1 August 2023 |
escitalopram oxalate | Lundbeck Australia Pty Ltd | 4.4 – Special warnings and precautions for use
| 23 August 2023 |
estradiol hemihydrate | Juno Pharmaceuticals Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 30 August 2023 |
estriol | Aspen Pharmacare Australia Pty Ltd | 4.4 – Special warnings and precautions for use
4.5 Interactions with other medicines and other forms of interactions
4.8 – Adverse effects (undesirable effects)
| 3 August 2023 |
fentanyl | Piramal Critical Care Pty Ltd | 4.4 – Special warnings and precautions for use
4.5 – Interactions with other medicines and other forms of interactions
4.9 – Overdosage
| 18 August 2023 |
fluorouracil | Pfizer Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 5 July 2023 |
hydroxychloroquine sulfate | Sanofi-Aventis Australia Pty Ltd | 4.4 – Special warnings and precautions for use
4.6 – Fertility, pregnancy and lactation
4.8 – Adverse effects (undesirable effects)
| 9 August 2023 |
lamotrigine | Aspen Pharmacare Australia Pty Ltd | 4.4 – Special warnings and precautions for use
5.3 Preclinical safety data
| 17 August 2023 |
methotrexate | Pfizer Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 7 August 2023 |
methoxyflurane | Medica Developments International Limited | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
4.9 – Overdosage
| 2 August 2023 |
pembrolizumab | Merch Sharpe & Dohme (Australia) Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 25 August 2023 |
pirfenidone | Roche Products Pty Ltd | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 31 August 2023 |
plerixafor | Sanofi-Aventis Pty Ltd | 4.6 Fertility, pregnancy and lactation
| 1 August 2023 |
pneumococcal purified capsular polysaccharides | Merch Sharpe & Dohme (Australia) Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 28 August 2023 |
tamsulosin hydrochloride | Astellas Pharma Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 26 July 2023 |
tioguanine | Aspen Pharmacare Australia Pty Ltd | 4.4 – Special warnings and precautions for use
| 14 August 2023 |
Disclaimer
Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional’s judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.
© Commonwealth of Australia 2023
