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 |
What to report? You don't need to be certain, just suspicious!
The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.
We particularly request reports of:
- all suspected reactions to new medicines (look for the Black Triangle ▼ in PI and CMI documents – this symbol identifies medicines that are new or being used differently)
- all suspected medicines interactions
- suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.
To report a suspected side effect or for more information about reporting, go to our ‘Report problem or side effect’ webpage.
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
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to tga.copyright@tga.gov.au.
For the latest safety information from the TGA, subscribe to the TGA Safety Information email list via the TGA website.
For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance Branch at ADR.Reports@tga.gov.au.
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