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 |
|---|---|---|---|
apalutamide | Janssen-Cilag Pty Ltd | 4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects)
| 5 January 2023 |
aspirin plus clopidogrel hydrogen sulfate | Sanofi-aventis Australia Pty Ltd | 4.4 – Special warnings and precautions for use
| 17 January 2023 |
atazanivir/ cobicistat | Bristol-Myers Squibb Australia Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 9 January 2023 |
budesonide | Chiesi Australia Pty Ltd | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 3 January 2023 |
buprenorphine | Camurus Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 17 January 2023 |
caplacizumab | Sanofi-Aventis Australia Pty Ltd | 4.4 – Special warnings and precautions for use 4.5 – Interactions with other medicines and other forms of interactions
| 19 January 2023 |
cisatracurium (as besilate) | Aspen Pharmacare Australia Pty Ltd | 4.6 – Fertility, pregnancy and lactation
4.8 – Adverse effects (undesirable effects)
| 23 January 2023 |
desferrioxamine mesilate | Pfizer Australia Pty Ltd | 4.2 – Dose and method of administration 4.4 – Special warnings and precautions for use 4.5 – Interactions with other medicines and other forms of interactions 4.7 – Effects on ability to drive and use machines 4.8 – Adverse effects (undesirable effects) 4.9 – Overdose
| 9 January 2023 |
desflurane | Baxter Healthcare Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 23 January 2023 |
diclofenac | Novartis Pharmaceuticals Australia Pty Ltd | 4.6 – Fertility, pregnancy and lactation
| 3 January 2023 |
digoxin-specific antibody fragment F(ab) (Ovine) | Phebra Pty Ltd | 4.4 – Special warnings and precautions for use
| 24 January 2023 |
equine antithymocyte immunoglobulin | Pfizer Australia Pty Ltd | 4.2 – Dose and method of administration
4.4 – Special warnings and precautions for use
4.6 – Fertility, pregnancy and lactation
4.8 – Adverse effects (undesirable effects)
| 19 January 2023 |
estradiol | Orion Pharma Aus Pty Limited | 4.2 – Dose and method of administration
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
| 16 December 2022 |
estradiol (as hemihydrate) and dydrogesterone | Viatris 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)
4.9 – Overdose
| 16 January 2023 |
fludarabine phosphate | Sanofi-aventis Australia Pty Ltd | 4.6 – Fertility, pregnancy and lactation
| 3 January 2023 |
hydrochlorothiazide/ telmisartan | Boehringer Ingelheim 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)
| 12 January 2023 |
irinotecan (as sucrosofate) | Servier Laboratories Australia Pty Ltd | 4.4 – Special warnings and precautions for use
4.6 – Fertility, pregnancy and lactation
4.8 – Adverse effects (undesirable effects)
| 20 January 2023 |
isoniazid | Arrow Pharma Pty Ltd | 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)
| 9 January 2023 |
lansoprazole | Pfizer Australia Pty Ltd | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 6 January 2023 |
laronidase (rch) | Sanofi-Aventis Australia Pty Ltd | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
4.9 – Overdose
| 12 January 2023 |
levothyroxine | Aspen Pharma Pty Ltd | 4.4 – Special warnings and precautions for use
| 15 December 2022 |
macitentan | Janssen-Cilag Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 5 January 2023 |
pembrolizumab | Merck Sharp & Dohme (Australia) Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 27 January 2023 |
pemigatinib | Specialised Therapeutics Alima Pty Ltd | 4.2 – Dose and method of administration 4.4 – Special warnings and precautions for use
| 17 January 2023 |
quinine bisulfate heptahydrate | 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 4.7 – Effects on ability to drive and use machines 4.8 – Adverse effects (undesirable effects)
| 9 January 2023 |
quinine bisulfate heptahydrate | 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 4.7 – Effects on ability to drive and use machines 4.8 – Adverse effects (undesirable effects) Updated to align with overseas product information | 10 January 2023 |
SARS-CoV-2 rS (NVX-CoV2373) | Biocelect Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 25 January 2023 |
teicoplanin | Sanofi-Aventis Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 23 January 2023 |
topiramate | Janssen-Cilag Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 9 January 2023 |
trimethoprim | Arrow Pharma Pty Ltd | 4.3 – Contraindications 4.6 – Fertility, pregnancy and lactation
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)
| 9 January 2023 |
umeclidinium (as bromide)/vilanterol (as trifenatate) | GlaxoSmithKline Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 5 January 2023 |
vancomycin | Pfizer Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 25 January 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
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For correspondence or further information about Medicines Safety Update, contact the TGA’s Pharmacovigilance Branch at [email protected].
