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Product Information safety updates - December 2025

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
desvenlafaxine (as succinate)

Pristiq

Pfizer Australia Pty Ltd

4.9 - Overdose

  • Added desvenlafaxine is the major active metabolite of venlafaxine. Hypoglycaemia has been reported in association with venlafaxine overdose.
2025-11-12
orphenadrine citrate

Norflex

iNova Pharmaceuticals (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added hallucinations with a frequency of uncommon
2025-11-05
paracetamol orphenadrine citrate

Norgesic

iNova Pharmaceuticals (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added under subheading 'Orphenadrine citrate' hallucinations with a frequency of less common
2025-11-05
ublituximab

Briumvi

Accelagen Pty Ltd

4.4 - Special warnings and precautions for use

  • Added new warning under subheading ‘Liver Injury'. Clinically significant liver injury, without findings of viral hepatitis, has been reported in the post marketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred weeks to months after administration. Patients treated with BRIUMVI found to have an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN, are potentially at risk for severe drug-induced liver injury. Obtain liver function tests prior to initiating treatment with BRIUMVI and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.

4.8 - Adverse effects (undesirable effects)

  • Added liver injury with a frequency of not known
2025-11-19
venlafaxine (as hydrochloride)

Elaxine SR / APO-Venlafaxine

Arrotex Pharmaceuticals Pty Ltd

4.9 - Overdose

  • Added new overdose event, hypoglycaemia, under subheading 'Signs and Symptoms'
2025-11-05
venlafaxine (as hydrochloride)

Venlafaxine XR-WGR

GM Pharma International Pty Ltd

4.9 - Overdose

  • Added new overdose event, hypoglycaemia, under subheading 'Signs and Symptoms'
2025-11-03
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