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Product Information safety updates - September 2023

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.

Table: Details of safety-related PI updates

Active ingredients

Brand name

Sponsor

PI updates

Date of approval

arsenic trioxide

Phenasen

Phebra Pty Ltd

4.3 – Contraindications

  • Added pregnancy and possibility of pregnancy

4.6 – Fertility, pregnancy and lactation

  • Updated information about pregnancy and contraception in male and female patients
  • Added information about period of abstinence for breastfeeding

23 August 2023

citalopram hydrobromide

Cipramil

Lundbeck Australia Pty Ltd

4.4 – Special warnings and precautions for use

  • Added subsection ‘Sexual dysfunction’
  • Addition of warning relating to persistent sexual dysfunction 

23 August 2023

darolutamide

Nubeqa

Bayer Australia Ltd

4.4 – Special warnings and precautions for use

  • Added information about hepatotoxicity

4.8 – Adverse effects (undesirable effects)

  • Updated Laboratory Test Abnormalities – liver function tests

23 August 2023

denosumab

Prolia

Amgen Australia Pty Ltd

4.4 – Special warnings and precautions for use

4.8 – Adverse effects (undesirable effects)

  • Updated information about risk of severe hypocalcaemia

30 August 2023

durvalumab

Imfinzi

Aspen Pharmacare Australia Pty Ltd
    1. – Dose and method of administration
  • Added ‘Myelitis transverse’ to the table ‘Treatment modifications and management recommendations for IMFINZI or IMFINZI in combination with tremelimumab’. With the development of myelitis transverse at any grade, IMFINZI should be permanently discontinued
  • Added immune–mediated arthritis and uveitis to ‘Other immune–mediated adverse reactions’ in the table ‘Treatment modifications and management recommendations for IMFINZI or IMFINZI in combination with tremelimumab’

4.4 – Special warnings and precautions for use

  • Added myelitis transverse and immune–mediated arthritis
    1. – Adverse effects (undesirable effects)
  • Added psoriasis and immune–mediated arthritis
  • Added subheading ‘Eye disorders’ to include uveitis
  • Added subsection ‘Post–marketing experience’ to include autoimmune haemolytic anaemia, myelitis transverse and systemic inflammatory response syndrome

1 August 2023

escitalopram oxalate

Lexapro

Lundbeck Australia Pty Ltd

4.4 – Special warnings and precautions for use

  • Added subsection ‘Sexual dysfunction’. Addition of warning relating to persistent sexual dysfunction

23 August 2023

estradiol hemihydrate

Estraderm MX

Juno Pharmaceuticals Pty Ltd

4.5 – Interactions with other medicines and other forms of interactions

  • Updated information about interaction between HRT and lamotrigine

30 August 2023

estriol

Ovestin cream

Ovestin tablets

Ovestin ovula

Aspen Pharmacare Australia Pty Ltd

4.4 – Special warnings and precautions for use

  • Added hereditary and acquired angioedema
  • Added hepatitis C warning to include ALT elevation observed with HCV combination regimen ombitasvir/paritaprevir/ritonavir and glecaprevir/pibrentasvir in women using ethinylestradiol–containing medicinal products. Caution is warranted for co–administration with the combination drug regimen

4.5 Interactions with other medicines and other forms of interactions

  • Added subsection ‘other interactions’ to include the warning of ALT elevation observed with HCV combination regimen ombitasvir/paritaprevir/ritonavir and glecaprevir/pibrentasvir in women using ethinylestradiol–containing medicinal products. Caution is warranted for co–administration with the combination drug regimen

4.8 – Adverse effects (undesirable effects)

  • Added angioedema

3 August 2023

fentanyl

Sublimaze

Piramal Critical Care Pty Ltd

4.4 – Special warnings and precautions for use

  • Added information about opioid use disorder

4.5 – Interactions with other medicines and other forms of interactions

  • Gabapentin and pregabalin

4.9 – Overdosage

  • Toxic leukoencephalopathy observed with fentanyl overdose

18 August 2023

fluorouracil

DBL Fluorouracil

Pfizer Australia Pty Ltd

4.8 – Adverse effects (undesirable effects)

  • Hepatocellular injury

5 July 2023

hydroxychloroquine sulfate

Plaquenil

Sanofi–Aventis Australia Pty Ltd

4.4 – Special warnings and precautions for use

  • Added Hepatitis B reactivation, hepatotoxicity and drug induced phospholipidosis

4.6 – Fertility, pregnancy and lactation

  • Added information about congenital malformations

4.8 – Adverse effects (undesirable effects)

  • Renal phospholipids
  • Hepatitis B reactivation

9 August 2023

lamotrigine

Lamictal

Aspen Pharmacare Australia Pty Ltd

4.4 – Special warnings and precautions for use

  • Added subsection ‘Cardiac Rhythm and Conduction Abnormalities’. Avoid the use of Lamictal in people who have cardiac conduction disorders, ventricular arrhythmias, or cardiac disease or abnormality. Concomitant use of other sodium channel blockers may increase the risk of proarrhythmia

5.3 Preclinical safety data

  • Added subsection ‘Effect of Lamictal on Cardiac Rhythm and Conduction’

17 August 2023

methotrexate

DBL Methotrexate

Pfizer Australia Pty Ltd

4.8 – Adverse effects (undesirable effects)

  • Added pulmonary oedema, brain oedema, oedema, and oedema peripheral

7 August 2023

methoxyflurane

Penthrox

Medica Developments International Limited

 

4.4 – Special warnings and precautions for use

  • Respiratory depression
  • Updated warning about occupational exposure

4.8 – Adverse effects (undesirable effects)

  • Respiratory depression

4.9 – Overdosage

  • Updated warning

2 August 2023

pembrolizumab

Keytruda

Merch Sharpe & Dohme (Australia) Pty Ltd

4.8 – Adverse effects (undesirable effects)

  • Added systemic inflammatory response syndrome

25 August 2023

pirfenidone

Esbriet

Roche Products Pty Ltd

4.4 – Special warnings and precautions for use

  • Added subsection ‘Severe Cutaneous Adverse Reactions’ (SCAR). If signs of SCAR occur interrupt Esbriet treatment until the aetiology of the reaction has been determined. If a SCAR is confirmed, permanently discontinue Esbriet

4.8 – Adverse effects (undesirable effects)

  • Added skin and subcutaneous tissue disorders: Stevens–Johnson syndrome (SJS); toxic epidermal necrolysis (TEN); and drug reaction with eosinophilia and systemic symptoms (DRESS)

31 August 2023

plerixafor

Mozobil

Sanofi–Aventis Pty Ltd

4.6 Fertility, pregnancy and lactation

  • Updated information about use in pregnancy and contraception use during treatment

1 August 2023

pneumococcal purified capsular polysaccharides

Pneumovax 23

Merch Sharpe & Dohme (Australia) Pty Ltd

4.8 – Adverse effects (undesirable effects)

  • Added systemic extensive swelling of the vaccinated limb with short onset time from vaccine administration.

28 August 2023

tamsulosin hydrochloride

Flomaxtra

Astellas Pharma Australia Pty Ltd

4.8 – Adverse effects (undesirable effects)

  • Chest discomfort

26 July 2023

tioguanine

Lanvis

Aspen Pharmacare Australia Pty Ltd

4.4 – Special warnings and precautions for use

  • Susceptibility to viral, fungal, and bacterial infections

14 August 2023

What to report? You don't need to be certain, just suspicious!

The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.

We particularly request reports of:

  • all suspected reactions to new medicines (look for the Black Triangle ▼ in PI and CMI documents – this symbol identifies medicines that are new or being used differently)
  • all suspected medicines interactions
  • suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.

To report a suspected side effect or for more information about reporting, go to our ‘Report problem or side effect’ webpage or contact the TGA's Pharmacovigilance Branch ADR.Reports@health.gov.au.

Disclaimer

Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.

© Commonwealth of Australia 2023

This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to tga.copyright@tga.gov.au.

For the latest safety information from the TGA, subscribe to the TGA Safety Information email list via the TGA website.

For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance Branch at ADR.Reports@tga.gov.au.

 

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