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.
| Active Ingredient | Brand name Sponsor |
PI updates (sections updated and summary of key information) | Date of approval |
|---|---|---|---|
| acalabrutinib | Calquence Capsules - external site AstraZeneca Pty Ltd |
4.1 - Therapeutic indications Deleted the lapsed provisionally registered indication for MCL and updated to the following: CALQUENCE is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). 4.4 - Special warnings and precautions for use Revised warning under the subheading 'Cardiac arrhythmias including atrial fibrillation and flutter'. Serious cardiac arrhythmias have occurred in patients treated with CALQUENCE. In the combined safety database of 1040 patients with haematologic malignancies treated with CALQUENCE monotherapy, Grade 3 atrial fibrillation and atrial flutter occurred in 1% of patients and Grade 1 or 2 in 3% of patients. Monitor for symptoms of cardiac arrhythmia, including atrial fibrillation and atrial flutter, (e.g. palpitations, dizziness, syncope, chest pain, dyspnoea) and obtain an ECG as appropriate. Added a new warning under the subheading 'Hepatotoxicity, including drug-induced liver injury'. Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including CALQUENCE. Evaluate bilirubin and transaminases at baseline and throughout treatment with CALQUENCE. For patients who develop abnormal liver tests after CALQUENCE, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold CALQUENCE. Upon confirmation of DILI, discontinue CALQUENCE. 4.8 - Adverse effects (Undesirable effects), Post-marketing experience Added new adverse effects 'cardiac arrhythmias', 'hepatotoxicity' and 'drug-induced liver injury' |
2026-04-27 |
| alemtuzumab | Sanofi-Aventis Australia Pty Ltd |
4.4 - Special warnings and precautions for use
|
2026-04-01 |
| allopurinol | APO-Allopurinol - external site / Zyloprim - external site Arrotex Pharmaceuticals Pty Ltd |
4.4 - Special warnings and precautions for use
4.5 - - Interactions with other medicines and other forms of interactions Added:
4.8 - Adverse effects (undesirable effects) Updates to:
|
2026-04-28 |
| amivantamab | Janssen-Cilag Pty Ltd |
4.2 - Dose and method of administration
4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
|
2026-04-01 |
| apalutamide | Janssen-Cilag Pty Ltd |
4.5 - Interactions with other medicines and other forms of interactions
|
2026-04-12 |
| aprepitant | Aprepitant ARX - external site 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)
|
2026-04-08 |
| armodafinil | Neuraxpharm Australia Pty Ltd |
4.5 - Interactions with other medicines and other forms of interactions
|
2026-04-22 |
| atovaquone/proguanil hydrochloride | Malarone Tablets - external site / Malarone Junior - external site GlaxoSmithKline Australia Pty Ltd |
4.8 - Adverse effects (undesirable effects)
|
2026-04-27 |
| azathioprine | Aspen Pharmacare Australia Pty Ltd |
4.4 - Special warnings and precautions for use
4.5 - Interactions with other medicines and other forms of interactions
4.6 - Fertility, pregnancy and lactation
4.8 - Adverse effects (undesirable effects)
|
2026-04-30 |
| azelastine hydrochloride, fluticasone propionate | Viatris Pty Ltd |
4.8 - Adverse effects (undesirable effects)
|
2026-03-30 |
