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When new safety information for medicines is identified, we work 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 our 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.
We monitor 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 our 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 we have 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 |
|---|---|---|---|
baclofen | Novartis Pharmaceuticals 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)
4.9 – Overdose
| 22 February 2024 |
baclofen | Novartis Pharmaceuticals 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)
| 22 February 2024 |
bevacizumab | Amgen Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 1 February 2024 |
carglumic acid | Recordati Rare Diseases Australia Pty Ltd | 4.2 - Dose and method of administration 4.4 - Special warnings and precautions for use
| 6 February 2024 |
cefoxitin sodium | Juno Pharmaceuticals Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 1 February 2024 |
ceftazidime (as pentahydrate) | Juno Pharmaceuticals Pty Ltd | 4.4 - Special warnings and precautions for use Added subheading ‘neurotoxicity’. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Withdrawal of medicine should be considered if there are signs of neurotoxicity. | 2 February 2024 |
cladribine | Merck Healthcare Pty Ltd | 4.4 - Special warnings and precaution for use:
| 29 February 2024 |
dexamfetamine sulfate | Aspen Pharmacare Australia Pty Ltd | 4.4 - Special warnings and precaution for use
4.9 – Overdose
| 26 February 2024 |
diltiazem hydrochloride | Sanofi-Aventis Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 5 February 2024 |
dorzolamide hydrochloride | Viatris Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 19 February 2024 |
doxorubicin hydrochloride | Baxter Healthcare Pty Ltd | 4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects)
4.6 - Fertility, pregnancy and lactation
| 16 February 2024 |
faricimab | Roche Products Pty Ltd |
4.8 - Adverse effects (undesirable effects)
| 15 February 2024 |
flucloxacillin | Alphapharm Pty Ltd | 4.5 - Interactions with other medicines and other forms of interactions
4.8 - Adverse effects (undesirable effects)
| 23 February 2024 |
fluorouracil injection | 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 February 2024 |
gadobutrol | Bayer Australia Ltd | 4.8 - Adverse effects (undesirable effects)
| 7 February 2024 |
hepatitis B surface antigen recombinant (yeast) | Glaxosmithkline Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 12 February 2024 |
infliximab | Janssen-Cilag Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 20 February 2024 |
liraglutide | Novo Nordisk Pharmaceuticals Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 13 February 2024 |
liraglutide | Novo Nordisk Pharmaceuticals Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 13 February 2024 |
lisdexamfetamine dimesilate | Takeda Pharmaceuticals Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 15 February 2024 |
medroxyprogesterone acetate | Pfizer Australia Pty Ltd | 4.4 - Special warnings and precaution for use
| 26 February 2024 |
morphine sulfate pentahydrate | Pfizer Australia Pty Ltd | 4.2 - Dose and method of administration
4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 15 February 2024 |
nusinersen (as heptadecasodium) | Biogen Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 31 January 2024 |
rituximab | Sandoz Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 14 February 2024 |
romiplostim | Amgen Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 15 February 2024 |