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.
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:
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 |
acetazolamide |
Diamox - external site Arrotex Pharmaceuticals Pty Ltd |
4.4 - Special warnings and precautions for use - Additional monitoring for long-term therapy
- Additional monitoring for ARDs and pulmonary oedema
4.7 - Effects on ability to drive and use machines - Added dizziness
- Added ataxia
|
2025-11-27 |
amivantamab |
Rybrevant - external site Janssen-Cilag Pty Ltd |
4.8 - Adverse effects (undesirable effects) - Postmarketing - Thrombocytopenia and neutropenia included when amivantamab is used in combination with carboplatin and pemetrexed
|
2025-12-23 |
caspofungin acetate |
Caspofungin AN - external site Juno Pharmaceuticals Pty Ltd |
4.4 - Special warnings and precautions for use - Updated use in hepatic impairment
4.5 - Interactions with other medicines and other forms of interactions - Monitoring liver enzymes added to Ciclosporin topic
4.8 - Adverse effects (undesirable effects) - Additional adverse effects to align with the SmPC relating to the following:
- Clinical adverse experiences in adult patients added (Table 4 added)
- Clinical adverse experiences in paediatric patients added (Table 9 added)
- Laboratory values updated
- Post-marketing experience updated with following new reactions:
- Hepatic necrosis
- Erythema multiforme, skin exfoliation
- Angioedema
- Pancreatitis
- Clinically significant renal dysfunction
|
2025-11-27 |
cinnarizine, dimenhydrinate |
Cizinate - external site Southern XP IP Pty Ltd |
4.3 Contraindications - Added new contraindication, CIZINATE is contraindicated for use in children under 6 years of age because of the potential for fatal respiratory depression, psychiatric and CNS (central nervous system) events
4.4 Special warnings and precautions for use - Added new warning under subheading 'Paediatric use'. CIZINATE is contraindicated for use in children under 6 years of age because of the potential for fatal respiratory depression, psychiatric and CNS events.
4.8 Adverse effects (undesirable effects) - Added new adverse event. Children less than 6 years of age also experienced aggression, hallucination and psychomotor hyperactivity.
4.9 Overdose - Added new overdose symptom information. Symptoms are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, reversible intellectual disability and cognition deficit in children less than 6 years of age, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children: coma or excitement may precede their occurrence. Tachycardia may develop.
|
2025-12-22 |
codeine phosphate hemihydrate, ibuprofen |
Nurofen Plus - external site Reckitt Benckiser Pty Ltd |
4.3 - Contraindications - Update to use in pregnancy
4.4 - Special warnings and precautions for use Added: - Adrenal insufficiency
- Endocrine effects
- Neonatal withdrawal syndrome
- Hepatobiliary disorders
- Gastrointestinal toxicity
- Kounis syndrome listed under Cardiovascular and cerebrovascular effects topic
- SCARs
- Hypokalaemia and renal tubular acidosis to Hazardous and harmful use topic
4.5 - Interactions with other medicines and other forms of interactions - Added gabapentinoids interaction
4.6 - Fertility, pregnancy and lactation - Neonatal withdrawal syndrome added to the Use in Pregnancy topic
- Full pregnancy contraindication
4.8 - Adverse effects (undesirable effects) Following adverse effects added to table: - Hypotension added at frequency very rare
- Adrenal insufficiency and androgen deficiency added under Endocrine Disorders at frequency Not known
- Hypokalaemia added at frequency Not known
- Kounis syndrome added at frequency Not known
- Central sleep apnoea syndrome added at frequency Not known
- Pancreatitis added at frequency Not known
- Spasm of sphincter of Oddi added at frequency Not known
- Severe Cutaneous Adverse Reactions (SCARs) added at frequency Very rare
- Renal tubular acidosis added at frequency Not known
- Irritability added at frequency Not known
- Antitussive therapy added at frequency Not known
4.9 - Overdose - Added toxic leukoencephalopathy
|
2025-11-18 |
colchicine |
Colgout - external site / Lengout - external site Aspen Pharmacare Australia Pty Ltd |
4.5 Interactions with other medicines and other forms of interactions - Added new interaction under subheading 'Moderate CYP3A4 inhibitors'. Co-administration with moderate CYP3A4 inhibitors such as calcium channel blockers (verapamil and diltiazem) will increase the exposure to colchicine, which may lead to colchicine induced toxicity including fatalities. If treatment with a moderate CYP3A4 inhibitor is required in patients with normal renal and hepatic function, a reduction in colchicine dosage or interruption of colchicine treatment is recommended.
|
2025-12-17 |
daptomycin |
Daptomycin Juno - external site Juno Pharmaceuticals Pty Ltd |
4.4 - Special warnings and precautions for use Addition of information relating to: - Institute alternative antibacterial therapy in cSSSI or RIE
- Severe cutaneous adverse reactions
- Symptoms of Tubulointerstitial Nephritis (TIN)
- Discontinuation in presence of unexplained muscle symptoms
- Peripheral neuropathy
- Increased CPK and renal impairment
- Treatment failure in non-susceptible organism and Clostridioides difficile-associated diarrhoea (CDAD)
- Revised myopathy information
4.5 - Interactions with other medicines and other forms of interactions Added: - Interactions in renal impairment
- Interference between daptomycin and assay reagents of prothrombin time/international normalised ratio (PT/INR)
4.8 - Adverse effects (undesirable effects) Addition of adverse effects: - Thrombocythaemia, thrombocytopaenia,
- Infusion reaction: tachycardia, wheezing, pyrexia, rigors, systemic flushing, vertigo, syncope and metallic taste
- Supraventricular tachycardia, extrasystole
|
2025-11-30 |
infliximab |
Ixifi - external site Pfizer Australia Pty Ltd |
4.8 - Adverse effects (undesirable effects) - Update to Immune System Disorders in Post-marketing experience, 'Rheumatoid Arthritis' and 'Inflammatory Bowel Disease' added to 'New onset paradoxical drug-induced immune disorders'.
- Added to Post-marketing experience: 'Musculoskeletal and connective tissue disorders', 'Rheumatoid arthritis' with a frequency unknown.
|
2025-12-14 |
ipilimumab |
Yervoy - external site Bristol-Myers Squibb Australia Pty Ltd |
4.4 - Special warnings and precautions for use - Update to Other immune-related adverse reactions section to include cases of Myocarditis-Myositis-Myasthenia Gravis Overlap Syndrome (presenting as an overlap of either two or all three conditions), some with fatal outcome, have been reported with nivolumab and nivolumab in combination with ipilimumab. Early recognition and aggressive management are essential to address associated morbidity and risk of mortality.
- 4.8 - Adverse effects (undesirable effects)
- Update to Postmarketing experience section to include Myocarditis-Myositis-Myasthenia Gravis Overlap Syndrome associated with the use of ipilimumab in combination with nivolumab
|
2025-12-10 |
isavuconazonium sulfate |
Cresemba - external site Pfizer Australia Pty Ltd |
4.8 - Adverse effects (undesirable effects) - Added 'hyponatraemia' to the tabulated list of adverse reactions, with a frequency of 'uncommon'
|
2025-12-23 |
leuprorelin acetate |
Eligard - external site Mundipharma Pty Ltd |
4.4 - Special warnings and precautions for use - Updated information relating to signs and symptoms of idiopathic intracranial hypertension.
- Updated information relating to metabolic syndrome in the post market setting
- Added Severe Cutaneous Adverse Reactions (SCARs) and recommendation to discontinue if confirmed
4.8 - Adverse effects (undesirable effects) - Added Stevens Johnson Syndrome / Toxic epidermal necrolysis, Toxic skin Eruption, erythema multiforme, diabetes to Table 3 under Skin and subcutaneous tissue disorders group
|
2025-12-21 |
neostigmine methylsulfate |
Neostigmine Juno - external site Juno Pharmaceuticals Pty Ltd |
4.3 - Contraindications Added: - Bronchial asthma
- Depolarizing muscle relaxants
4.4 - Special warnings and precautions for use - Addition of the following warnings:
- Severe cholinergic reaction in hyperreactive patients
- Cyclopropane or halone anaesthesia
- Use of anticholinesterase agents in patients with intestinal anastomoses.
- 4.5 - Interactions with other medicines and other forms of interactions
- Added non-depolarising muscle relaxants
4.8 - Adverse effects (undesirable effects) - Addition to Post marketing: decreased cardiac conduction; cholinergic syndrome; myasthenia gravis, increase intestinal motility; muscle spasm; hypersensitivity; angioedema; hyperhidrosis, increased lacrimation
|
2025-11-30 |
nicorandil |
Apo-Nicorandil - external site Arrotex Pharmaceuticals Pty Ltd |
4.3 - Contraindications - Added:
- Acute pulmonary oedema
- Cardiac decompensation.
4.4 - Special warnings and precautions for use Added: - Glaucoma
- G6PD deficiency
- Heart failure
- Decrease of blood pressure
4.5 - Interactions with other medicines and other forms of interactions Added: - Dapoxetine and other medical products that may increase potassium levels
- NSAIDs
4.7 - Effects on ability to drive and use machines - Added blood pressure lowering effects and weakness
|
2025-11-30 |
nifedipine |
APO-Nifedipine XR - external site Arrotex Pharmaceuticals Pty Ltd |
4.3 - Contraindications Added: - Cardiogenic shock, unstable angina, clinically significant aortic stenosis
- Acute angina attacks or for secondary prevention of myocardial infarction.
- Severe hypotension.
- History of gastro-intestinal obstruction, oesophageal obstruction, or and degree of reduced intestinal lumen diameter of the intestinal tract. It must not be used in patients with a Kock pouch (ileostomy after proctocolectomy), inflammatory bowel disease or Crohn's disease.
- 4.5 - Interactions with other medicines and other forms of interactions
- Updated digoxin interaction
4.8 - Adverse effects (undesirable effects) - Updated cardiovascular system, vascular disorders, digestive system, nervous system and immune system disorders.
- Post-marketing AE updated for respiratory, thoracic, and mediastinal disorders.
|
2025-12-01 |
nirmatrelvir and ritonavir |
Paxlovid - external site Pfizer Australia Pty Ltd |
4.5 - Interactions with other medicines and other forms of interactions - Concomitant use of mavacamten is contraindicated
|
2025-12-01 |
nivolumab |
Opdivo - external site Bristol-Myers Squibb Australia Pty Ltd |
4.4 - Special warnings and precautions for use - Added cases of Myocarditis-Myositis-Myasthenia Gravis Overlap Syndrome (presenting as an overlap of either two or all three conditions), some with fatal outcome, have been reported with nivolumab and nivolumab in combination with ipilimumab. Early recognition and aggressive management are essential to address associated morbidity and risk of mortality.
4.8 - Adverse effects (undesirable effects) - Update to Postmarketing experience section to include Myocarditis-Myositis-Myasthenia Gravis Overlap Syndrome
|
2025-12-10 |
nusinersen heptadecasodium |
Spinraza - external site Biogen Australia Pty Ltd |
4.8 - Adverse effects (undesirable effects) - Post-marketing experience: added pyrexia as a non-serious adverse reaction
|
2025-12-10 |
ocrelizumab |
Ocrevus - external site Roche Products Pty Ltd |
4.4 - Special warnings and precautions for use - Addition of liver injury as warning and precaution
4.8 - Adverse effects (undesirable effects) - Addition of liver injury as adverse drug reactions from post-marketing experience
|
2025-12-01 |
rimegepant sulfate |
Nurtec ODT - external site Pfizer Australia Pty Ltd |
4.4 - Special warnings and precautions for use - Additional detail on anaphylactic reactions
4.8 - Adverse effects (undesirable effects) - Addition of Hypersensitivity reactions
|
2025-12-16 |
sugammadex sodium |
Sugammadex Juno - external site Juno Pharmaceuticals Pty Ltd |
4.4 - Special warnings and precautions for use Added - Monitoring for recurrence of neuromuscular blockade
- Prolonged neuromuscular blockade
- Adequate ventilation
- Caution in patients receiving anticoagulation
- Depth of anaesthesia, awareness under surgical anaesthesia
- Caution for use with rocuronium or vecuronium
4.8 - Adverse effects (undesirable effects) Added: - Dysgeusia, headache, nausea, urticaria, pruritus, dizziness, vomiting and abdominal pain
- In post-marketing reports, hypersensitivity events
- Cardiac disorders
- Respiratory, thoracic, and mediastinal disorders adverse effects
- Severe systemic disease
|
2025-12-01 |
sulfamethoxazole, trimethoprim |
Bactrim DS - external site Echo Therapeutics Pty Ltd |
4.4 - Special warnings and precautions for use - Addition of warning on Circulatory shock
4.8 - Adverse effects (undesirable effects) - Added hypersensitivity of the respiratory tract
- Added acute and delayed lung injury
- Added circulatory shock
|
2025-12-18 |
terbinafine hydrochloride |
Lamisil - external site Novartis Pharmaceuticals Australia Pty Ltd |
4.4 - Special warnings and precautions for use · Addition of warning regarding risk of Thrombotic thrombocytopenic purpura (TTP) 4.8 - Adverse effects (undesirable effects) - Addition of thrombotic thrombocytopenic purpura (TT) of unknown frequency under 'Blood and lymphatic system disorders'
|
2025-12-09 |
testosterone |
Testavan - external site Clinect Pty Ltd |
4.5 Interactions with other medicines and other forms of interactions - Added new interaction. Androgens may potentiate the effects of ciclosporin and increase risk of nephrotoxicity.
|
2025-12-21 |
testosterone undecanoate |
Reandron - external site Aspen Pharmacare Australia Pty Ltd |
4.4 Special warnings and precautions for use - Added new information to enhance the existing warning regarding pulmonary oily microembolism. The patient should be observed during and immediately after each injection in order to allow for early recognition of possible signs and symptoms of pulmonary oily microembolism.
4.5 Interactions with other medicines and other forms of interactions - Added new interaction under subheading 'Effects of androgens on other drugs'. Androgens may potentiate the effects of ciclosporin and increase risk of nephrotoxicity. The concurrent administration of testosterone with ACTH or corticosteroids may enhance oedema formation; thus these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema.
- Added new interaction under subheading 'Insulin and other anti-diabetic medicines'. Androgens may improve glucose tolerance and decrease the need for insulin or other antidiabetic medicines in diabetic patients. Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during Reandron 1000 treatment. Concomitant use of testosterone replacement therapy and sodium-glucose co-transporter 2 (SGLT-2) inhibitors has been associated with an increased risk of erythrocytosis. Since both substances may independently elevate haematocrit levels, a cumulative effect is possible. Monitoring of haematocrit and haemoglobin levels is recommended in patients receiving both treatments.
4.8 Adverse effects (undesirable effects) - Added pulmonary oil microembolism with a frequency of rare.
|
2025-12-10 |
