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Product Information safety updates - February 2024
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 |
---|---|---|---|
allopurinol | Arrotex Pharmaceuticals 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)
| 22 January 2024 |
apomorphine hydrochloride hemihydrate | Pharmaceuticals Australia Pty Ltd | 4.3 - Contraindications 4.5 - Interactions with other medicines and other forms of interactions
| 5 January 2024 |
azacitidine | Celgene Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 11 January 2024 |
belzutifan | Merck Sharp & Dohme (Australia) Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 24 January 2024 |
bosentan monohydrate | Janssen-Cilag Pty Ltd | 4.6 - Fertility, pregnancy, and lactation
| 24 January 2024 |
carbidopa monohydrate/levodopa | Alphapharm 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)
| 31 January 2024 |
cariprazine hydrochloride | Gedeon Richter Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 11 January 2024 |
cefaclor monohydrate | Viatris Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 18 January 2024 |
cefalexin monohydrate
| Aspen Pharmacare Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 8 January 2024 |
cefazolin sodium | Aft Pharmaceuticals Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 15 January 2024 |
cefotaxime | Pfizer Australia Pty Ltd | 4.8 - Adverse effects (Undesirable effects)
| 23 January 2024 |
ceftazidime pentahydrate | Alphapharm Pty Ltd | 4.4 - Special warnings and precautions for use
| 17 January 2024 |
ceftazidime pentahydrate | Aft Pharmaceuticals Pty Ltd | 4.4 - Special warnings and precautions for use
| 22 January 2024 |
ceftazidime pentahydrate | Fresenius Kabi Australia Pty Limited |
| 29 January 2024 |
ceftolozane sulfate / tazobactam sodium | Merck Sharp & Dohme (Australia) Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 31 January 2024 |
ceftriaxone sodium | Aft Pharmaceuticals Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 11 January 2024 |
ceftriaxone sodium | Alphapharm Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 12 January 2024 |
cefuroxime axetil | Aspen Pharmacare Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 9 January 2024 |
cefuroxime sodium | Southern Xp Ip Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 17 January 2024 |
cephazolin sodium | Alphapharm Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 19 January 2024 |
clomifene citrate | Sanofi-Aventis Australia Pty Ltd | 4.3 - Contraindications
| 25 January 2024 |
conjugated estrogens / bazedoxifene acetate | Pfizer Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 16 January 2024 |
diazoxide | Pfizer Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 9 January 2024 |
epoprostenol sodium | Janssen-Cilag Pty Ltd | 4.4 - Special warnings and precautions for use
| 5 January 2024 |
esketamine hydrochloride | Janssen-Cilag Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 16 January 2024 |
Factor VIII inhibitor bypassing fraction | Takeda Pharmaceuticals | 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)
| 24 January 2024 |
flutamide | Alphapharm Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 22 January 2024 |
glibenclamide/ metformin hydrochloride | Alphapharm Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 15 January 2024 |
hydroxychloroquine sulfate | Sanofi-Aventis Australia Pty Ltd | 4.4 - Special warnings and precautions for use
| 11 January 2024 |
mercaptopurine monohydrate | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | 4.4 - Special warnings and precautions for use
| 15 January 2024 |
mercaptopurine monohydrate | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 15 January 2024 |
meropenem | Pfizer Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 23 January 2024 |
methotrexate | Orion Pharma (AUS) Pty Limited | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 2 January 2024 |
methylphenidate hydrochloride | Novartis Pharmaceuticals Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 30 January 2024 |
methylprednisolone acetate | Pfizer Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 15 January 2024 |
osimertinib mesilate | AstraZeneca Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 29 January 2024 |
perflutren | Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific | 4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects)
| 23 January 2024 |
phenobarbital sodium | Aspen Pharmacare Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 4 January 2024 |
ponesimod | Janssen-Cilag Pty Ltd | 4.4 - Special warnings and precautions for use
| 4 January 2024 |
rituximab | Celltrion Healthcare Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 8 December 2023 |
sacituzumab govitecan | Gilead Sciences Pty Ltd | 4.4 - Special warnings and precautions for use
| 22 December 2023 |
sulfamethoxazole/ trimethoprim tablets | Echo Therapeutics Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 12 January 2024 |
sulfamethoxazole/ trimethoprim Infusion for injection | Echo Therapeutics Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 12 January 2024 |
tazobactam sodium piperacillin sodium | Pfizer Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 11 January 2024 |
teduglutide | Takeda Pharmaceuticals Australia Pty Ltd | 4.4 - Special warnings and precautions for use
| 31 January 2024 |
zolpidem tartrate | Sanofi-Aventis Australia Pty Ltd | 4.4 Special warnings and precautions for use
| 3 January 2024 |
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