Product Information safety updates - December 2022
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 Medicines Safety Update article, it will be linked to in the 'Safety issue' column.
|
Active ingredients |
Brand name Sponsor |
PI updates (sections updated and summary of key information) |
Date of approval |
|---|---|---|---|
|
adefovir dipivoxil |
Apotex Pty Ltd |
4.4 – Special warnings and precautions for use
4.6 – Fertility, pregnancy and lactation
4.8 – Adverse effects (undesirable effects)
|
25 October 2022 |
|
brinzolamide |
Novartis Pharmaceuticals Australia Pty Ltd |
4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects)
4.5 – Interactions with other medicines and other forms of interactions
|
2 November 2022 |
|
brinzolamide/ brimonidine tartare |
Novartis Pharmaceuticals Australia Pty Ltd |
4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects)
|
17 October 2022 |
|
brinzolamide/ timolol |
Novartis Pharmaceuticals Australia Pty Ltd |
4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects)
|
31 October 2022 |
|
candesartan, hydrochlorothiazide |
AstraZeneca Pty Ltd |
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
|
5 October 2022 |
|
captopril |
Arrow Pharma Pty Ltd |
4.3 – Contraindications
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) |
25 November 2022 |
|
cisplatin |
DBL Cisplatin Injection - external site Pfizer Australia Pty Ltd |
4.3 – Contraindications
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)
|
27 October 2022 |
|
clofarabine |
Sanofi-Aventis Australia Pty Ltd |
4.6 – Fertility, pregnancy and lactation
|
28 November 2022 |
|
crizotinib |
Pfizer Australia Pty Ltd |
4.8 – Adverse effects (undesirable effects)
|
7 November 2022 |
|
darolutamide |
Bayer Australia Ltd |
4.8 – Adverse effects (undesirable effects)
|
27 October 2022 |
|
darunavir |
Janssen-Cilag Pty Ltd |
4.8 – Adverse effects (undesirable effects)
|
7 November 2022 |
|
darunavir/ cobicistat |
Janssen-Cilag Pty Ltd |
4.8 – Adverse effects (undesirable effects)
|
7 November 2022 |
|
darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide |
Janssen-Cilag Pty Ltd |
4.8 – Adverse effects (undesirable effects)
|
11 November 2022 |
|
dolutegravir/ rilpivirine |
ViiV Healthcare Pty Ltd |
4.6 – Fertility, pregnancy and lactation
|
25 November 2022 |
|
elasomeran |
Moderna Australia Pty Ltd |
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
|
14 October 2022 |
|
elasomeran, imelasomeran |
Spikevax Bivalent Original/ Omicron - external site Moderna Australia Pty Ltd |
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
|
14 October 2022 |
|
emicizumab |
Roche Products Pty Ltd |
4.8 – Adverse effects (undesirable effects)
|
31 October 2022 |
|
epoetin alfa |
Janssen-Cilag Pty Ltd |
4.2 – Dose and method of administration
|
17 November 2022 |
|
estradiol hemihydrate |
Viatris Pty Ltd |
4.4 – Special warnings and precautions for use
4.5 – Interactions with other medicines and other forms of interactions
|
14 November 2022 |
|
gabapentin |
Viatris Pty Ltd |
4.4 – Special warnings and precautions for use
|
19 October 2022 |
|
gadoteric acid |
Guerbet Australia Pty Ltd |
4.8 – Adverse effects (undesirable effects)
|
9 November 2022 |
|
human menopausal gonadotrophin |
Ferring Pharmaceuticals Pty Ltd |
4.8 – Adverse effects (undesirable effects)
|
4 November 2022 |
|
hydrochlorothiazide, valsartan |
Novartis Pharmaceuticals Australia Pty Ltd |
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
|
27 October 2022 |
|
hydrochlorothiazide, valsartan, amlodipine |
Amlodipine/ Valstartan/ HCT Novartis - external site Novartis Pharmaceuticals Australia Pty Ltd |
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
|
27 October 2022 |
|
hydrochlorothiazide, valsartan, amlodipine |
Novartis Pharmaceuticals Australia Pty Ltd |
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
|
27 October 2022 |
|
hydroxychloroquine sulfate |
Sanofi-Aventis Australia Pty Ltd |
4.4 – Special warnings and precautions for use 4.5 – Interactions with other medicines and other forms of interactions
|
26 October 2022 |
|
ibuprofen/ codeine |
Reckitt Benckiser Pty Ltd |
4.4 – Special warnings and precautions for use
4.5 – Interactions with other medicines and other forms of interactions
|
28 October 2022 |
|
influenza virus HA |
Vaxigrip Tetra - external site Sanofi-Aventis Australia Pty Ltd |
4.8 – Adverse effects (undesirable effects)
|
14 November 2022 |
|
levetiracetam |
UCB Australia Pty Ltd (T/A UCB Pharma Division of UCB Australia) |
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
|
24 November 2022
|
|
mefenamic acid
|
Pfizer Australia Pty Ltd |
4.2 – Dose and method of administration 4.3 – Contraindications
4.6 – Fertility, pregnancy and lactation
|
28 October 2022 |
|
nirmatrelvir/ ritonavir |
Pfizer Australia Pty Ltd |
4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects)
|
4 November 2022 |
|
omeprazole
|
Pharmaco Australia Ltd |
4.4 – Special warnings and precautions of use 4.8 – Adverse effects (undesirable effects)
|
21 November 2022
|
|
osimertinib mesilate |
AstraZeneca Pty Ltd |
4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects)
|
5 November 2022 |
|
phenobarbital (phenobarbitone) |
Arrow Pharma Pty Ltd |
4.3 – Contraindications
4.4 – Special warnings and precautions for use
4.5 – Interactions with other medicines and other forms of interactions 4.6 – Fertility, pregnancy and lactation 4.8 – Adverse effects (undesirable effects)
|
16 November 2022 |
|
phenytoin
|
DBL Phenytoin Injection BP - external site Pfizer Australia Pty Ltd |
4.4 – Special warnings and precautions for use
4.6 – Fertility, pregnancy and lactation
|
5 October 2022 |
|
prochlorperazine maleate/ prochlorperazine mesilate |
Sanofi-aventis Australia Pty Ltd
|
4.3 – Contraindications
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)
|
4 November 2022 |
|
rabeprazole sodium |
Janssen-Cilag Pty Ltd |
4.4 – Special warnings and precautions of use 4.8 – Adverse effects (undesirable effects)
|
24 November 2022 |
|
reboxetine mesilate |
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 (undesirable effects)
|
8 November 2022 |
|
roxithromycin |
Rulide and Rulide D - external site Sanofi-Aventis Australia Pty Ltd |
4.4 – Special warnings and precautions for use 4.5 – Interactions with other medicines and other forms of interactions
|
21 October 2022 |
|
SARS-CoV-2 rS [NVX-CoV2373] |
Biocelect Pty Ltd |
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
|
29 November 2022 |
|
sorafenib |
Bayer Australia Ltd |
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (Undesirable effects)
|
12 October 2022 |
|
tacrolimus |
Prograf and Advagraf XL - external site Astellas Pharma Australia Pty Ltd |
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
|
10 November 2022 |
|
tozinameran
|
Comirnaty [tris/sucrose presentation] - external site Pfizer Australia Pty Ltd |
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
|
6 October 2022 |
|
tozinameran
|
Pfizer Australia Pty Ltd |
4.8 – Adverse effects (undesirable effects)
|
14 November 2022 |
|
tozinameran/ riltozinameran |
Comirnaty Bivalent BA.1 - external site Pfizer Australia Pty Ltd
|
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
|
14 November 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.
To report a suspected side effect or for more information about reporting, go to our 'Report problem or side effect' webpage or contact the TGA's Pharmacovigilance Branch ADR.Reports@health.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 Branch at ADR.Reports@tga.gov.au.
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Product Information safety updates – February 2023
Medicines Safety Update - Information for health professionals -
Product Information safety updates - November 2022
Medicines Safety Update - Information for health professionals -
Product Information safety updates - March 2023
Medicines Safety Update - Information for health professionals