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 (sections updated and summary of key information) | Date of approval |
|---|---|---|---|
alteplase (rch) | Boehringer Ingelheim Pty Limited | 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)
| 14 March 2023 |
amoxicillin | Aspen Pharmacare 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)
| 20 March 2023 |
amoxicillin trihydrate/ potassium clavulanate | Aspen Pharmacare Australia Pty Ltd | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 3 April 2023 |
atazanavir | Bristol-Myers Squibb Australia Pty Ltd | 4.3 – Contraindications
4.5 – Interactions with other medicines and other forms of interactions
| 21 April 2023 |
atezolizumab | Roche Products Pty Ltd | 4.2 – Dose and method of administration
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 15 March 2023 |
baricitinib | Eli Lilly Australia Pty Ltd | Boxed warning
4.4 – Special warnings and precautions for use
4.8 – Adverse Effects (Undesirable Effects)
| 20 April 2023 |
botulinum toxin type A | Allergan Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 14 April 2023 |
budesonide | Johnson & Johnson Pacific 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 4.9 – Overdose | 9 March 2023 |
cabergoline | Pfizer Australia Pty Ltd | 4.4 – Special warnings and precautions for use 4.8 – Adverse effects
| 31 March 2023 |
cabotegravir (as sodium) | ViiV Healthcare Pty Ltd | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 20 April 2023 |
cabotegravir and rilpivirine | ViiV Healthcare Pty Ltd | 4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects)
| 27 April 2023 |
cefalexin | Aspen Pharmacare Australia Pty Ltd | 4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects)
| 14 April 2023 |
cefuroxime (as axetil) | Aspen Pharmacare Australia Pty Ltd | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 17 March 2023 |
ChAdOx1-S Vaccine | AstraZeneca Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 17 April 2023 |
citalopram hydrobromide | Lundbeck Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 15 March 2023 |
cobimetinib fumarate | Roche Products Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 20 April 2023 |
dabrafenib mesilate | Novartis Pharmaceuticals Australia Pty Ltd | 4.4 – Special warning and precautions for use 4.8 – Adverse effects (undesirable effects)
| 2 March 2023 |
dexamethasone sodium phosphate | DBL Dexamethasone Sodium Phosphate Pfizer Australia Pty Ltd | 4.3 – Contraindications
4.4 – Special warnings and precautions
4.5 – Interactions with other medicines and other forms of interactions
4.6 – Fertility, pregnancy and lactation
4.8 – Adverse effects (undesirable effects)
| 12 April 2023 |
dolutegravir sodium | ViiV Healthcare Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 29 March 2023 |
elasomeran imelasomeran, elasomeran | Spikevax Bivalent Original/Omicron Moderna Australia Pty Ltd | 4.8 – Adverse effects
| 21 February 2023 |
ertugliflozin pyroglutamic acid | Merck Sharp & Dohme (Australia) Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 24 April 2023 |
ertugliflozin pyroglutamic acid, metformin hydrochloride | Merck Sharp & Dohme (Australia) Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 24 April 2023 |
ertugliflozin pyroglutamic acid, sitagliptin phosphate monohydrate | Merck Sharp & Dohme (Australia) Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 24 April 2023 |
estradiol, norethisterone acetate, relugolix | Gedeon Richter Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 31 March 2023 |
ethinylestradiol, cyproterone acetate | Bayer Australia Ltd | 4.3 – Contraindications
4.4 – Special warnings and precautions for use
4.5 – Interactions with other medicines and other forms of interactions
| 11 April 2023 |
ethinylestradiol, dienogest | Bayer Australia Ltd | 4.3 – Contraindications
4.4 – Special warnings and precautions for use
4.5 – Interactions with other medicines and other forms of interactions
| 11 April 2023 |
ethinylestradiol, drospirenone | Bayer Australia Ltd | 4.3 – Contraindications
4.4 – Special warnings and precautions for use
4.5 – Interactions with other medicines and other forms of interactions
| 11 April 2023 |
ethinylestradiol, levonorgestrel | Bayer Australia Ltd | 4.3 – Contraindications
4.4 – Special warnings and precautions for use
4.5 – Interactions with other medicines and other forms of interactions
| 17 April 2023 |
etonogestrel | Organon Pharma Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 18 April 2023 |
ibandronate sodium | Atnahs Pharma Australia Pty Ltd | 4.2 – Dose and method of administration
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 24 February 2023 |
influenza virus haemagglutinin quadrivalent vaccine | Seqirus Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 8 March 2023 |
isoniazid | Arrow Pharma Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 3 April 2023 |
itraconazole | Janssen-Cilag Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 24 April 2023 |
lamivudine and dolutegravir sodium | ViiV Healthcare Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 13 April 2023 |
lanthanum (as lanthanum carbonate hydrate) | Takeda Pharmaceuticals Australia Pty Ltd | 4.3 – Contraindications
4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 3 April 2023 |
methotrexate | Pfizer (Australia) Methotrexate Pfizer Australia Pty Ltd | 4.8 – Adverse effects
| 24 March 2023 |
multivitamin | Baxter Healthcare Pty Ltd | 4.3 – Contraindications 4.4 – Special warnings and precautions for use
| 14 April 2023 |
nirmatrelvir and ritonavir | Pfizer Australia Pty Ltd | 4.4 – Special warnings and precautions for use
4.5 – Interactions with other medicines and other forms of interactions
| 26 April 2023 |
nomegestrol acetate and estradiol hemihydrate | Theramex Australia Pty Ltd | 4.4 – Special warnings and precautions for use
| 2 March 2023 |
ocrelizumab | Roche Products Pty Ltd | 4.4 – Special warnings and precautions for use
| 3 April 2023 |
pegvaliase | BioMarin Pharmaceutical Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 20 March 2023 |
pravastatin | Arrow Pharma Pty Ltd | 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 4.8 – Adverse effects (undesirable effects)
| 1 March 2023 |
proxymetacaine hydrochloride | Alcon Laboratories Australia Pty Ltd | 4.4 – Special Warnings and Precautions for Use
| 20 April 2023 |
rifaximin | Norgine Pty Ltd | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 20 April 2023 |
rivastigmine rivastigmine hydrogen tartrate | Novartis Pharmaceuticals Australia Pty Ltd | 4.4 – Special warnings and precautions for use
4.5 – Interactions with other medicines and other forms of interactions
| 14 March 2023 |
rurioctocog alfa pegol | Takeda Pharmaceuticals Australia Pty Ltd | 4.3 – Contraindications 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 11 April 2023 |
sodium oxidronate | Landauer Radiopharmaceuticals Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 19 April 2023 |
susoctocog alfa | Takeda Pharmaceuticals Australia Pty Ltd | 4.3 – Contraindications
4.8 – Adverse effects (undesirable effects)
| 9 March 2023 |
tofacitinib | Pfizer Australia Pty Ltd | Boxed warning
4.2 – Dose and Method of Administration
4.4 – Special warnings and precautions for use
4.8 – Adverse Effects (Undesirable Effects)
| 20 April 2023 |
tozinameran famtozinameran riltozinameran | Comirnaty COVID-19 Vaccine and Comirnaty (tris/sucrose presentation) Comirnaty Original/ Omicron BA. 1 Comirnaty Original/ Omicron BA. 4-5 Pfizer Australia Pty Ltd | 4.8 – Adverse effects
| 21 February 2023 |
upadacitinib | Abbvie Pty Ltd | Boxed warning
4.4 – Special warnings and precautions for use
4.8 – Adverse Effects (Undesirable Effects)
| 20 April 2023 |
voriconazole | Pfizer Australia Pty Ltd | 4.4 – Special warnings and precautions for use
| 29 March 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].
