The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
When the Therapeutic Goods Administration’s (TGA) ongoing safety monitoring identifies new safety information for medicines, we work closely with the sponsors of those medicines to update Product Information (PI) to ensure that health professionals and consumers have access to this information. Please see below details of some the medicines that have had safety related updates to their PI since December 2021.
New safety information can be identified in various ways. 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 an 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 Medicines Safety Update (MSU) article, it will be linked to in the ‘Safety issue’ column.
| Active ingredients | Brand name Sponsor |
PI updates | Date of approval |
|---|---|---|---|
|
abatacept |
Bristol-Myers Squibb Australia Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
8 December 2021 |
|
amisulpride |
Sanofi-Aventis Australia Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
25 February 2022 |
|
carfilzomib |
Amgen Australia Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
8 February 2022 |
|
ChAdOx1-S |
AstraZeneca Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
15 March 2022 |
|
clozapine |
Viatris Pty Ltd Pfizer Australia Pty Ltd |
New boxed warning on clozapine-induced gastrointestinal hypomotility 4.4 -Special warnings and precautions for use
4.8 - Adverse effects
|
28 February 2022 |
|
donepezil |
Pfizer 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
|
4 January 2022 |
|
esketamine |
Janssen-Cilag Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
10 February 2022 |
|
glecaprevir and pibrentasvir |
AbbVie Pty Ltd |
4.2 - Dose and method of administration and 4.3 Contraindications
4.4 Special warnings and precautions for use
|
23 March 2022 |
|
ibuprofen and codeine |
Reckitt Benckiser Pty Ltd |
4.4 - Special warnings and precautions for use
4.6 - Fertility, pregnancy and lactation
4.8 - Adverse effects
|
23 February 2022 |
|
lisdexamfetamine |
Takeda Pharmaceuticals Australia Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
28 March 2022 |
|
methoxy polyethylene glycol-epoetin beta |
Roche Products Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
21 January 2022 |
|
mycophenolic acid |
Novartis Pharmaceuticals Australia Pty Ltd |
4.4 - Special warnings and precautions for use New warning on potential increased severity of COVID-19 due to the medicine's cytostatic effect on B- and T-lymphocytes |
16 March 2022 |
|
nintedanib |
Boehringer Ingelheim Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
14 December 2021 |
|
pentamidine |
DBL Pentamidine Isethionate - external site Pfizer Australia Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
7 January 2022 |
|
phenobarbital |
Phenobarb tablets - external site Arrow Pharma Pty Ltd Phenobarbitone injection - external site Aspen Pharmacare Australia Pty Ltd |
4.4 - Special warnings and precautions for use and 4.6 - Fertility, pregnancy and lactation
5.3 - Preclinical safety data
|
1 March 2022 |
|
phenytoin |
Viatris Pty Ltd |
4.4 - Special warnings and precautions for use and 4.6 - Fertility, pregnancy and lactation
|
8 February 2022 |
|
primidone |
Link Medical Products Pty Ltd |
4.4 - Special warnings and precautions for use and 4.6 - Fertility, pregnancy and lactation
5.3 - Preclinical safety data
|
3 February 2022 |
|
ribociclib |
Novartis Pharmaceuticals Australia Pty Ltd |
4.4 - Special warnings and precautions for use
|
7 March 2022 |
|
ruxolitinib |
Novartis Pharmaceuticals Australia Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
17 March 2022 |
|
sodium valproate |
Sanofi-Aventis Australia Pty Ltd |
4.4 - Special warnings and precautions for use and 4.5 - Interactions with other medicines and other forms of interactions
|
16 December 2021 |
|
sofosbuvir |
Gilead Sciences Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
16 February 2022 |
|
sofosbuvir and ledipasvir |
Gilead Sciences Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
10 February 2022 |
|
sofosbuvir and velpatasvir |
Gilead Sciences Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
10 February 2022 |
|
Sofosbuvir, velpatasvir and voxilaprevir |
Gilead Sciences Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects
|
10 February 2022 |
|
tacrolimus |
Prograf, Prograf XL and Advagraf XL - external site Astellas Pharma Australia Pty Ltd |
4.8 - Adverse effects
|
31 March 2022 |
|
tapentadol |
Palexia IR and Palexia SR - external site Seqirus Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 Adverse effects
|
1 March 2022 |
|
teriflunomide |
Sanofi-Aventis Australia Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 Adverse effects
|
2 February 2022 |
|
tenofovir, darunavir, cobicistat and emtricitabine |
Janssen-Cilag Pty Ltd |
4.4 - Special warnings and precautions for use and 4.8 - Adverse effects
|
5 January 2022 |
|
zonisamide |
Amdipharm Mercury Australia Pty Ltd |
4.4 - Special warnings and precautions for use and 4.6 - Fertility, pregnancy and lactation Expanded details on the risks of zonisamide use in pregnancy and emphasised the importance of adequate contraception and pre-conception care. |
28 February 2022 |
|
zopiclone |
Sanofi-Aventis Pty Ltd |
4.1 - Therapeutic indications 4.2 - Dose and method of administration 4.4 - Special warnings and precautions for use and 4.6 Fertility, pregnancy and lactation
|
1 February 2022 |
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.
Reports may be submitted:
- online at www.tga.gov.au
- by fax to 02 6232 8392
- by email to ADR.Reports@tga.gov.au
For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.gov.au.
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 2022
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 and Special Access Branch at ADR.Reports@tga.gov.au.