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:
- 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
- dd 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 article, it will be linked to in the ‘Safety issue’ column.
Table: Details of safety-related PI updates
Active ingredients | Brand name Sponsor | PI updates (sections updated and summary of key information) | Date of approval |
|---|---|---|---|
amikacin | Pfizer Australia Pty Ltd | 4.4 – Special warnings and precautions for use
| 10 October 2022 |
anagrelide hydrochloride | Takeda Pharmaceuticals Australia 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)
| 19 September 2022 |
atezolizumab | Roche Products Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 7 September 2022 |
avalglucosidase alfa | Sanofi-Aventis Australia Pty Ltd | 4.7 – Effects on ability to drive and use machines
4.8 – Adverse effects (undesirable effects)
6.4 – Special precautions for storage
| 14 October 2022 |
bendamustine hydrochloride | Janssen-Cilag Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 27 September 2022 |
ChAdOx1-S | AstraZeneca Pty Ltd | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 9 September 2022 |
dapagliflozin (as propanediol monohydrate)/ metformin hydrochloride | AstraZeneca Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 19 September 2022 |
daratumumab | Janssen-Cilag Pty Ltd | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 21 September 2022 |
empagliflozin | Boehringer Ingelheim Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 9 September 2022 |
empagliflozin plus metformin | Boehringer Ingelheim Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 9 September 2022 |
empagliflozin plus linagliptin | Boehringer Ingelheim Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 9 September 2022 |
encorafenib | Pierre Fabre Australia Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 13 September 2022 |
esketamine (as hydrochloride) | Janssen-Cilag Pty Ltd | 4.2 – Dose and method of administration
4.8 – Adverse effects (undesirable effects)
| 16 September 2022 |
exenatide | AstraZeneca Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 12 September 2022 |
gentamicin | / Pfizer Australia Pty Ltd | 4.4 – Special warnings and precautions for use
| 26 September 2022 |
gilteritinib fumarate | Astellas Pharma Australia Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 14 September 2022 |
heparin sodium | 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) 6.2 – Incompatibilities
| 12 September 2022 |
hydrochlorothiazide | Phebra Pty Ltd | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 26 September 2022 |
irinotecan hydrochloride trihydrate | 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)
| 27 September 2022 |
isavuconazole (as isavuconazonium sulfate) | Pfizer Australia Pty Ltd | 4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects)
| 28 September 2022 |
levetiracetam | Pfizer Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 29 September 2022 |
metronidazole | Pfizer Australia Pty Ltd | 4.3 – Contraindications 4.8 – Adverse effects (undesirable effects)
| 16 September 2022 |
nivolumab | Bristol-Myers Squibb Australia Pty Ltd | 4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects)
| 13 October 2022 |
phenytoin | Juno Pharmaceuticals Pty Ltd | 4.4 – Special warnings and precautions for use
4.6 – Fertility, pregnancy and lactation
| 20 September 2022 |
saxagliptin/ dapagliflozin | AstraZeneca Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 6 September 2022 |
sertraline | Viatris Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 11 October 2022 |
siponimod | Novartis Pharmaceuticals Australia Pty Ltd | 4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects)
| 27 September 2022 |
tobramycin | / / Pfizer Australia Pty Ltd | 4.4 – Special warnings and precautions for use
| 26 September 2022 |
valaciclovir hydrochloride | Arrow Pharma 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) | 10 October 2022 |
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
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