Sub menu

 
 

Product Information safety updates - January 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
atazanavir/cobicistat

Evotaz 

Bristol-Myers Squibb Australia Pty Ltd

4.3 – Contraindications

  • Added: coadministration with drugs that are strong inducers of CYP3A4, including apalutamide, encorafenib and ivosidenib

4.5 – Interactions with other medicines and other forms of interactions  

  • Added to antineoplastics section: apalutamide, encorafenib, ivosidenib
  • Added: kinase inhibitors section (fostamatinib)
  • Added: gonadotropin-releasing hormone (GnRH) antagonist section (elagolix)
11 December 2024
avacopan

Tavneos

Seqirus Pty Ltd

 

  1. – Interactions with other medicines and other forms of interactions  
  • Interaction with simvastatin: inhibition magnitude changed from “weak” to “moderate”
25 November 2024
ciclosporin 

Cequa

Sun Pharma ANZ Pty Ltd

4.8 – Adverse effects (undesirable effects)

  • Added: urinary tract infection 
17 December 2024
ciprofloxacin 

Ciprofloxacin-BL

Roflo

IPC-Ciprofloxacin 

IPCA Pharma (Australia) Pty Ltd

Boxed warning

  • Added information about fluoroquinolones, including ciprofloxacin, having been associated with disabling and potentially irreversible serious adverse reactions involving different body systems, which 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 and musculoskeletal systems, and psychiatric effects 

4.4 – Special warnings and precautions for use

  • Introductory paragraph about disabling and potentially persistent adverse reactions updated to include that patients of any age or without pre-existing risk factors have experienced these adverse reactions
10 December 2024
dalteparin sodium

Fragmin

Pfizer Australia Pty Ltd

4.4 – Special warnings and precautions for use and 4.5 – Interactions with other medicines and other forms of interactions

  • Added: concomitant use with drugs affecting haemostasis, such as thrombolytic agents, oral anticoagulants, NSAIDs, platelet inhibitors or dextran, is not recommended

4.8 – Adverse effects (undesirable effects) 

  • Added: hyperkalaemia
13 December 2024
esomeprazole + amoxicillin + clarithromycin 

Nexium Hp7

AstraZeneca Pty Ltd

4.4 – Special warnings and precautions for use

  • Acute tubulointerstitial nephritis warning updated to add that acute tubulointerstitial nephritis can progress to renal failure 

4.8 – Adverse effects (undesirable effects)

  • Added: tubulointerstitial nephritis (with possible progression to renal failure)
24 December 2024
ethinylestradiol/ levonorgestrel

Seasonique

Theramex Australia Pty Ltd

4.8 – Adverse effects (undesirable effects) 

  • Added: increased transaminases
12 December 2024
fluvastatin

Lescol XL

Novartis Pharmaceuticals Australia Pty Ltd

4.8 – Adverse effects (undesirable effects)

  • Added: depression 
10 December 2024
glatiramer acetate

Copaxone

Teva Pharma Australia Pty Ltd

4.4 – Special warnings and precautions for use 

  • Updated information about anaphylactic reactions 

4.8 – Adverse effects (undesirable effects) 

  • Anaphylactic reactions added to post marketing experience section
2 December 2024

imiglucerase

 

Cerezyme

Sanofi-Aventis Australia Pty Ltd

4.4 – Special warnings and precautions for use

  • Added: infusion-associated reactions 

4.8 – Adverse effects (undesirable effects) 

  • Added: transient hypertension
10 December 2024
levothyroxine sodium

Eltroxin 

Aspen Pharmacare Australia Pty Ltd

4.3 – Contraindications

  • Added: Use with anti-thyroid agents during pregnancy

4.4 – Special warnings and precautions for use

  • Warning broadened for switching from other levothyroxine-containing products
  • Added warning about biotin interference with thyroid function tests

4.5 – Interactions with other medicines and other forms of interactions

  • Added information about ability of biotin-containing products to interfere with thyroid function tests based on a biotin/streptavidin interaction
  • Added information about interactions with statins, tyrosine kinase inhibitors, St John’s wort, tamoxifen, methadone and 5-fluorouracil

4.6 – Fertility, pregnancy and lactation

  • Added: use of levothyroxine with anti-thyroid agents during pregnancy is contraindicated

4.8 – Adverse effects (undesirable effects)

  • Added: angioedema, rash, urticaria
3 December 2024 
methadone hydrochloride

Physeptone

Aspen Pharmacare Australia Pty Ltd

4.4 – Special warnings and precautions for use

  • Added: adrenal insufficiency
  • Added: decreased sex hormone and increased prolactin

4.8 – Adverse effects (undesirable effects) 

  • Added to endocrine section: decreased libido, impotence and amenorrhea with long-term use
  • Added to gastrointestinal section: loss of appetite 
  • Added to neurological section: weakness, fatigue, low blood pressure
11 December 2024
nirmatrelvir/ritonavir

Paxlovid

Pfizer Australia Pty Ltd

4.3 – Contraindications

  • Added: coadministration with enzalutamide

4.5 – Interactions with other medicines and other forms of interactions

  • Added: decrease in albendazole plasma concentration

Please note: These changes are not present in the PI document’s summary table of changes due to a superseding PI update approved on 13 December 2024

12 December 2024
palbociclib

Ibrance

Pfizer Australia Pty Ltd

4.8 – Adverse effects (undesirable effects) 

  • Added to post-marketing experience category under investigations: blood creatinine increased
9 December 2024
pembrolizumab

Keytruda

Merck Sharp & Dohme (Australia) Pty Limited

 4.4 – Special warnings and precautions for use

  • Pericarditis moved to immune-mediated adverse reactions with frequency of less than 1% 
9 December 2024
propofol

Diprivan

Aspen Pharmacare Australia Pty Ltd

4.8 – Adverse effects (undesirable effects) 

  • Added: hepatobiliary disorders (hepatitis and acute hepatic failure)
10 December 2024
rifaximin

Xifaxan

Norgine Pty Ltd

4.4 – Special warnings and precautions for use  

  • Added warning about severe cutaneous adverse reactions with the use of rifaximin in patients with cirrhosis 

4.8 – Adverse effects (undesirable effects) 

  • Post-marketing experience table updated to include severe cutaneous adverse reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis in patients with cirrhosis
27 November 2024
teriflunomide

Teri-EM

Emcure Pharmaceuticals Pty Ltd

4.4 – Special warnings and precautions for use

  • Added information about cases of herpes virus infections, including oral herpes, herpes zoster, herpetic meningoencephalitis and herpes dissemination, having been reported and which may occur at any time during treatment 

4.8 – Adverse effects (undesirable effects)

  • Added: herpes infection
2 December 2024
tirzepatide

Mounjaro

Eli Lilly Australia Pty Ltd

4.8 – Adverse effects (undesirable effects) 

  • Increased frequency of abdominal pain
9 December 2024
topiramate

Topamax 

Topamax Sprinkle 

Janssen-Cilag Pty Ltd

4.6 – Fertility, pregnancy and lactation

  • Added: observational studies data on neurodevelopment disorders in children exposed in utero to topiramate
19 December 2024
toremifene (as citrate)

Fareston

Orion Pharma (AUS) Pty Limited

4.3 – Contraindications

  • Added: hypersensitivity to active ingredient or any excipients

4.8 – Adverse effects (undesirable effects) 

  • Added adverse effects: hypertriglyceridemia, thrombocytopenia, anaemia, uterine bleeding, rash and leukopenia
  • Depression, itching and fatigue moved to common incidence category of adverse effects 
  • Added information about risk of increased endometrial changes
25 November 2024

triptorelin embonate

 

Diphereline

Ipsen Pty Ltd

4.3 – Contraindications

  • Added: non hormone-dependent tumours or following surgical castration

 

11 December 2024
Topics

Related content

Help us improve the Therapeutic Goods Administration site