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Product Information safety updates - March 2026

Medicines Safety Update
Published

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:

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 

  

amlodipine (as besilate) and atorvastatin (as calcium trihydrate)

  

Caduet

Aspen Pharmacare Australia Pty Ltd

4.4 Special warnings and precautions for use 

  • Added new warning under subheading 'Skeletal Muscle'. The risk of myopathy and/or rhabdomyolysis may be increased by concomitant administration of HMG-CoA reductase inhibitors (e.g. atorvastatin) and daptomycin. Consideration should be given to temporarily suspend CADUET in patients taking daptomycin unless the benefits of concomitant administration outweigh the risk. If co- administration cannot be avoided, CK levels should be measured 2-3 times per week and patients should be closely monitored for any signs or symptoms that might represent myopathy.  

4.5 Interactions with other medicines and other forms of interactions 

  • Added new interaction under subheading 'Daptomycin'. Cases of myopathy and/or rhabdomyolysis have been reported with HMG-CoA reductase inhibitors (e.g. atorvastatin) co-administered with daptomycin. If co-administration cannot be avoided, appropriate clinical monitoring is recommended. 

4.8 Adverse effects (undesirable effects) 

  • Added lichenoid drug reaction
  • Added vasculitis
2026-02-18

  

atorvastatin (as calcium trihydrate)

 Lipitor

Aspen Pharmacare Australia Pty Ltd

4.4 Special warnings and precautions for use 

  • Added new warning under subheading 'Skeletal Muscle'. The risk of myopathy and/or rhabdomyolysis may be increased by concomitant administration of HMG-CoA reductase inhibitors (e.g. atorvastatin) and daptomycin. Consideration should be given to temporarily suspend LIPITOR in patients taking daptomycin unless the benefits of concomitant administration outweigh the risk. If co- administration cannot be avoided, CK levels should be measured 2-3 times per week and patients should be closely monitored for any signs or symptoms that might represent myopathy. 

4.5 Interactions with other medicines and other forms of interactions 

  • Added new interaction under subheading 'Daptomycin'. Cases of myopathy and/or rhabdomyolysis have been reported with HMG-CoA reductase inhibitors (e.g. atorvastatin) co-administered with daptomycin. If co-administration cannot be avoided, appropriate clinical monitoring is recommended. 

4.8 Adverse effects (undesirable effects) 

  • Added lichenoid drug reaction
  • Added vasculitis
2026-02-26

  

azacitidine

  

Vidaza

Bristol-Myers Squibb Australia Pty Ltd

4.4 Special warnings and precautions for use 

  • Added new warning under subheading 'Cardiac and Pulmonary Disease'. Limited data from the pivotal clinical study in patients with a known history of cardiovascular or pulmonary disease showed a significantly increased incidence of cardiac events with azacitidine. It is therefore advised to exercise caution when prescribing azacitidine to these patients. 

4.8 Adverse effects (undesirable effects) 

  • Added pericardial effusion with frequency common
  • Added pericarditis with frequency uncommon
  • Added new adverse event under subheading 'Cardiac Events'. Data from a clinical study allowing enrolment of patients with known history of cardiovascular or pulmonary disease showed an increase in cardiac events in patients with newly diagnosed AML treated with azacitidine.
2026-02-19

  

epcoritamab

  

Epkinly

Abbvie Pty Ltd

4.4 Special warnings and precautions for use 

  • Added new warning for hypogammaglobulinaemia under subheading ‘Serious infections'. Hypogammaglobulinaemia has also been reported in patients receiving epcoritamab. Immunoglobulin (Ig) levels should be monitored prior to and during treatment. Patients should be treated according to local guidelines, including infection precautions and antimicrobial prophylaxis. 

4.8 Adverse effects (undesirable effects) 

  • Added hypogammaglobulinaemia
2026-02-01

  

flucloxacillin (as sodium)

  

Staphylex / Flopen Viatris

Alphapharm Pty Ltd

4.5 Interactions with other medicines and other forms of interactions: 

  • Added new interaction under subheading 'Posaconazole'. Flucloxacillin (a CYP450 inducer) may decrease plasma posaconazole concentrations. Concomitant use of posaconazole and flucloxacillin should be avoided unless the benefit to the patient outweighs the risk.
2026-02-16

  

human serum albumin-free (hsa-free) varicella vaccine, (live, attenuated)

  

Varilrix

GlaxoSmithKline Australia Pty Ltd

4.4 Special warnings and precautions for use 

  • Added new warning: Encephalitis has been reported during post-marketing use of live attenuated varicella vaccines including VARILRIX. Fatal outcomes have been observed, especially in patients who were immunocompromised. Vaccinees or parents should be instructed to seek prompt medical attention if they or their child experience, after vaccination, symptoms suggestive of encephalitis such as loss or reduced levels of consciousness, convulsions or ataxia accompanied by fever and headache. 

4.8 Adverse effects (Undesirable effects) 

  • Added new description of selected adverse reaction: Encephalitis has been observed following vaccination with live attenuated varicella vaccines. Fatal outcome was reported in a few cases, especially in immunocompromised people.
2026-02-25

  

ibuprofen

  

Caldolor

Phebra Pty Ltd

4.4 Special warnings and precautions for use 

  • Added new warning under subheading 'Cardiovascular and cerebrovascular effects'. Cases of Kounis syndrome have been reported in patients treated with ibuprofen. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction.
  • Added new warning under subheading 'Renal'. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients treated with ibuprofen over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose. 

4.8 Adverse effects (undesirable effects) 

  • Added Kounis syndrome with frequency not known
  • Added hypokalaemia with frequency not known
  • Added renal tubular acidosis with frequency not known. Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of ibuprofen at higher than recommended doses. 

4.9 Overdose 

  • Added prolonged use at higher than recommended doses or overdose may result in renal tubular acidosis and hypokalaemia. Symptoms may include reduced level of consciousness and generalised weakness.
2026-02-04

  

isoniazid

  

Isoniazid

Arrotex Pharmaceuticals Pty Ltd

4.4 Special warnings and precautions for use 

  • Added new warning under subheading 'Cerebellar Syndrome'. Cerebellar syndrome which may include abnormal motor coordination presenting as gait, trunk, and limb ataxia, dysmetria and dysdiadochokinesia, intention tremor, dysarthria, or nystagmus, has been reported in post-marketing case reports with the use of isoniazid. Most cases of cerebellar syndrome involved patients with chronic kidney disease (CKD), however, cerebellar syndrome was also reported in patients without CKD. Discontinue isoniazid if symptoms or signs of cerebellar syndrome occur. 

4.8 Adverse effects (undesirable effects) 

  • Added new adverse event under subheading 'Nervous system'. Cerebellar syndrome, which may include abnormal motor coordination manifesting as gait, trunk, and limb ataxia, dysmetria and dysdiadochokinesia, intention tremor, dysarthria, or nystagmus, have been reported in post marketing case reports.
2026-02-09

  

measles, mumps, rubella and varicella vaccine (live, attenuated)

  

Priorix-Tetra

GlaxoSmithKline Australia Pty Ltd

4.4 Special warnings and precautions for use 

  • Added new warning: Encephalitis has been reported during post-marketing use of live attenuated measles, mumps, rubella and varicella vaccines including PRIORIX-TETRA. Fatal outcomes have been observed, especially in patients who were immunocompromised. Vaccinees or parents should be instructed to seek prompt medical attention if they or their child experience, after vaccination, symptoms suggestive of encephalitis such as loss or reduced levels of consciousness, convulsions or ataxia accompanied by fever and headache. 

4.8 Adverse effects (Undesirable effects) 

  • Added new description of selected adverse reaction, encephalitis has been observed following vaccination with live attenuated measles, mumps, rubella and varicella vaccines. Fatal outcome was reported in a few cases, especially in immunocompromised people.
2026-02-23

  

promethazine hydrochloride

  

DBL Promethazine Hydrochloride

Pfizer Australia Pty Ltd

4.3 Contraindications 

  • Updated contraindication for use in paediatric patients less than two years of age because of potential for psychiatric and CNS (central nervous system) events. 

4.4 Special warnings and precautions for use 

  • Updated warning under subheading 'Paediatric use' with potential for psychiatric and CNS events in patients two years of age and older. 

4.8 Adverse effects (Undesirable effects) 

  • Added new adverse event under subheading 'CNS'. Children less than 6 years of age also experienced aggression, hallucination and psychomotor hyperactivity.  

4.9 Overdose 

  • Added new overdose symptoms under subheading 'symptoms'. They 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.
2026-02-04

  

venlafaxine (as hydrochloride)

  

Efexor-XR

Viatris Pty Ltd

4.9 Overdose 

  • Added 'hypoglycaemia' as a new symptom of overdose
2026-02-01
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