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Product Information safety updates - February 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.

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 the TGA has 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
acitretin

Neotigason - external site

Teva Pharma Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added ‘psychotic disorders’.
  • Added ‘avoid exposure to sunlight’.

4.8 - Adverse effects (undesirable effects) 

  • Added ‘altered mood’.
  • Added ‘psychotic disorders’.
  • Added ‘skin fissures’.
8 January 2025
andusomeran

Spikevax Xbb.1.5 - external site

Moderna Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added Chronic urticaria.
6 January 2025
avelumab

Bavencio - external site

Merck Healthcare Pty Ltd

4.4 - Special warnings and precautions for use 

  • Added ‘neutropenia’.

4.8 - Adverse effects (undesirable effects) 

  • Added ‘neutropenia’.
22 January 2025
avibactam sodium and ceftazidime pentahydrate

Zavicefta - external site

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added update to dermatological adverse events.
30 January 2025
axitinib

Inlyta - external site

Pfizer Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added renal failure.
7 January 2025
azathioprine

Imuran - external site

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added ‘non-cirrhotic portal hypertension’.
  • Added ‘portosinusoidal vascular disease’.

4.8 - Adverse effects (undesirable effects)

  • Added ‘non-cirrhotic portal hypertension’.
  • Added ‘portosinusoidal vascular disease’.
14 January 2025
cabotegravir and rilpivirine

Cabenuva - external site

ViiV Healthcare Pty Ltd

4.6 - Adverse effects (undesirable effects) 

  • Added ‘Stevens-Johnson syndrome, toxic epidermal necrolysis’.
21 January 2025
ciprofloxacin

Ciprol - external site

Apo-Ciprofloxacin - external site

Arrotex Pharmaceuticals Pty Ltd

Boxed warning

  • Added fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system, musculoskeletal system and psychiatric effects.

4.4 - Special warnings and precautions for use

  • Updated introductory paragraph regarding disabling and potentially persistent adverse reactions to include patients of any age or without pre-existing risk factors have experienced these adverse reactions.
14 January 2025
clarithromycin

Klacid - external site 

Kalixocin - external site

Viatris Pty Ltd

4.3 - Contraindications

  • Added concomitant administration ivabradine is contraindicated, as this may result in increased plasma exposure of ivabradine.

4.5 - Interactions with other medicines and other forms of interactions

  • Added new interaction under subheading ‘Ivabradine’.
13 January 2025
codeine phosphate hemihydrate and aspirin

Aspalgin - external site

Viatris Pty Ltd

4.3 - Contraindications

  • Added use in the third trimester of pregnancy.

4.4 - Special warnings and precautions for use

  • Added new warning under subheading ‘Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS)’.

4.6 - Fertility, Pregnancy and Lactation

  • Added contraindicated in the third trimester of pregnancy.
  • Added new warning under subheading ‘Oligohydramnios and Neonatal Renal Impairment’.

4.8 - Adverse effects (undesirable effects)

  • Under new heading ‘Pregnancy, puerperium and perinatal conditions’ added oligohydramnios, neonatal renal impairment and drug reaction with Eosinophilia with Systemic Symptoms (DRESS).
17 January 2025
elasomeran

Spikevax - external site

Moderna Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added Chronic urticaria.
6 January 2025
esomeprazole

Nexium Intravenous - external site

Nexium - external site 

Esopreze - external site

Astrazeneca Pty Ltd

4.4 - Special warnings and precautions for use

  • Updated acute tubulointerstitial nephritis warning and added acute tubulointerstitial nephritis can progress to renal failure.

4.8 - Adverse effects (undesirable effects)

  • Added Tubulointerstitial nephritis (with possible progression to renal failure).
3 January 2025
esomeprazole + amoxicillin + clarithromycin

Nexium Hp7 - external site

Astrazeneca Pty Ltd

4.3 - Contraindications

  • Added concomitant administration of ivabradine is contraindicated, as this may result in increased plasma exposure of ivabradine.

4.5 - Interactions with other medicines and other forms of interactions

  • Added new interaction under subheading ‘Ivabradine’.
20 January 2025
etrasimod

Velsipity - external site

Pfizer Australia Pty Ltd

4.2 - Dose and method of administration

  • Added guidance for missed dose.

4.4 - Special warnings and precautions for use

  • Added information about when to seek guidance from a cardiologist for patients with heart or cerebrovascular disease.
  • Updated clinical trial information for concomitant use of etrasimod and corticosteroids.
  • Updated washout period and duration of contraception.

 4.7 - Fertility, pregnancy and lactation 

  • Updated duration of contraception.
7 January 2025
hydrocortisone sodium succinate

Solu-cortef - external site

Solu-cortef act-o-vial - external site

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added ‘exacerbation or reactivation of existing or latent infections’.
  • Added ‘monitoring and management of infections’.

4.5 - Interactions with other medicines and other forms of interactions

  • Updated information on anticoagulants.
9 January 2025
ibrutinib

Imbruvica - external site

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use

  • Revised precaution on hepatotoxicity.

4.8 - Adverse effects (undesirable effects)

  • Added ‘cutaneous vasculitis’.
23 January 2025
influenza virus haemagglutinin

Vaxigrip Tetra - external site

Sanofi-Aventis Australia Pty Ltd

4.8 Adverse effects (undesirable effects)

  • Added rash.
16 January 2025
isotretinoin

Roaccutane - external site 

Roche Products Pty Ltd

4.4 - Special warnings and precautions for use

  • Updated wording within subheading ‘Psychiatric disorders’ to recommend that all patients have an assessment of their mental health, and of family history of mental health conditions, before starting treatment.
  • Added new warning under subheading ‘Sexual disorders’ that erectile dysfunction, decreased libido, vulvovaginal dryness, anhedonia and gynaecomastia have been reported with isotretinoin.

4.8 - Adverse effects (undesirable effects)

  • Added vulvovaginal dryness and anhedonia.
23 January 2025
ixekizumab

Taltz

Eli Lilly Australia Pty Ltd

4.8 - Adverse effects (undesirable effects) 

  • Added ‘eczematous eruptions’.
10 January 2025
liraglutide

Victoza - external site

Saxenda - external site

Novo Nordisk Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

  • Added new warning under subheading ‘Aspiration in association with general anaesthesia or deep sedation’ to include cases of aspiration pneumonia have been reported in patients receiving GLP-1 RAs undergoing general anaesthesia or deep sedation despite reported adherence to preoperative fasting recommendations. Therefore, the increased risk of residual gastric content because of delayed gastric emptying should be considered prior to performing procedures with GA or deep sedation.

4.8 - Adverse effects (undesirable effects)

  • Added footnote to Gastrointestinal disorders - Intestinal obstruction*

*Grouped term covering PTs Intestinal obstruction, Ileus, small intestinal obstruction.

19 December 2024
metronidazole benzoate

Flagyl S - external site

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added ‘Posterior Reversible Encephalopathy Syndrome (PRES)’.
  • Added ‘inflammatory bowel disease (IBD).

4.8 - Adverse effects (undesirable effects)

  • Added ‘Posterior Reversible Encephalopathy Syndrome (PRES)’.
  • Added ‘inflammatory bowel disease (IBD).
30 January 2025
montelukast

Singulair - external site

Lukair - external site

Organon Pharma Pty Ltd

Boxed warning

  • Added Serious Neuropsychiatric events – Neuropsychiatric events such as behavioural changes, depression and suicidality have been reported in all age groups. Events are generally mild and may be coincidental. Symptoms may be serious and continue if the treatment is not withdrawn. Treatment with montelukast should be discontinued if neuropsychiatric symptoms occur during treatment.

4.4 - Special warnings and precautions for use

  • Updated the ‘neuropsychiatric events’ subheading with additional information including advice for prescriber, patients and caregivers to be alert for changes in behaviour or new neuropsychiatric symptoms and if changes in behaviour are observed, or if new neuropsychiatric symptoms or suicidal thoughts and/or behaviour occur, patients should be advised to discontinue and contact a healthcare provider immediately.
9 January 2025
norfloxacin

APO-Norfloxacin - external site

Arrotex Pharmaceuticals Pty Ltd

Boxed warning

  • Added fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system, musculoskeletal system and psychiatric effects. 

4.4 - Special warnings and precautions for use

  • Updated introductory paragraph regarding disabling and potentially persistent adverse reactions to include patients of any age or without pre-existing risk factors have experienced these adverse reactions.
17 January 2025
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