TGA Product Information safety updates 31 August

TGA

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

acamprosate calcium

Campral

Alphapharm Pty Ltd

4.6 - Fertility, pregnancy and lactation

  • Updated information about lactation

4.8 - Adverse effects (undesirable effects)

  • Vesiculo-bullous eruptions

18 July 2023

buprenorphine

Norspan

Bupredermal

Mundipharma Pty Ltd

4.2 - Dose and method of administration

  • Support with rescue analgesics during titration

4.5 ­- Interactions with other medicines and other forms of interactions

  • Updated terminology for warning about interaction with ketoconazole and tablet and film formulations

4 July 2023

carvedilol

Dilatrend

Pharmaco Australia Ltd

4.4 - Special warnings and precautions for use

  • Anaphylactic reaction

11 July 2023

diltiazem

Cardizem

Cardizem CD

Vasocardol

Vasocardol CD

Sanofi-Aventis Australia Pty Ltd

4.9 - Overdose

  • Risk of non-cardiogenic pulmonary oedema due to diltiazem overdose

6 July 2023

eliglustat

Cerdelga

Sanofi-Aventis Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Cough

23 June 2023

erythromycin (as ethyl succinate)

E-Mycin

Alphapharm Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

  • Hydroxychloroquine and chloroquine
  • Corticosteroids
  • Fexofenadine

4.8 - Adverse effects (undesirable effects)

  • Safety warning regarding fungal overgrowth

13 July 2023

escitalopram oxalate

Lexapro

Lundbeck Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Hyperprolactinaemia associated with SSRIs/SNRIs

3 July 2023

fluorometholone

FML

AbbVie Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Eyelid ptosis and corneal calcification

24 July 2023

influenza virus haemagglutinin

Afluria Quad

Seqirus Pty Ltd

4.8 ­- Adverse effects (undesirable effects)

  • Syncope and presyncope

6 July 2023

liraglutide

Saxenda

Novo Nordisk Pharmaceuticals Pty Ltd

4.8 ­- Adverse effects (undesirable effects)

  • Rash

5 July 2023

lisdexamfetamine dimesilate

Vyvanse

Takeda Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Alopecia

17 July 2023

live varicella vaccine

Varivax

Merck Sharp & Dohme (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Syncope

7 July 2023

mavacamten

Camzyos

Bristol-Myers Squibb Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Risk of heart failure due to systolic dysfunction following major cardiac surgery

17 July 2023

moclobemide

Aurorix

Amira

Viatris Pty Ltd

4.4 - Special warnings and precautions for use

  • Warning about use with buprenorphine-containing products

4.5 - Interactions with other medicines and other forms of interactions

  • Updated information about concomitant use with opiates

10 July 2023

naproxen

Naprosyn

Naprosyn SR

Atnahs Pharma Australia Pty Ltd

4.3 - Contraindications

  • Third trimester pregnancy

4.6 - Fertility, pregnancy and lactation

  • Information about risk of NSAID use in pregnancy, risk of oligohydramnios and neonatal renal impairment

22 June 2023

onasemnogene abeparvovec

Zolgensma

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

5.1 - Pharmacodynamic properties

  • Risk of tumorigenicity

17 July 2023

oxycodone hydrochloride

Oxynorm

Mundipharma Pty Ltd

4.2 - Dose and method of administration

  • Guidance on initiation, monitoring and discontinuing treatment

4.4 - Special warnings and precautions for use

  • Guidance on opioid use disorder, initiating treatment, monitoring

4.8 - Adverse effects (undesirable effects)

  • Revision to frequency of opioid withdrawal syndrome, drug dependence and opioid tolerance
  • Additional guidance on drug dependence, opioid tolerance and opioid withdrawal syndrome
  • Augmentation in restless legs syndrome

4.9 - Overdosage

  • Toxic leukoencephalopathy

24 July 2023

penicillamine

D-Penamine

Alphapharm Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Vasculitis

14 July 2023

phenylephrine hydrochloride/prednisolone acetate

Prednefrin Forte

AbbVie Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Eyelid ptosis

21 July 2023

praziquantel

Biltricide

Bayer Australia Ltd

4.4 - Special warnings and precautions for use

  • Warning about interaction with efavirenz

4.5 - Interactions with other medicines and other forms of interactions

  • Efavirenz
  • Ritonavir

7 July 2023

ravulizumab rch

Ultomiris

Alexion Pharmaceuticals Australasia Pty Ltd

4.3 - Contraindications

4.4 - Special warnings and precautions for use

  • Updated information about administration while unvaccinated against Neisseria meningitidis

4.5 - Interactions with other medicines and other forms of interactions

  • Neonatal Fc receptor (FcRn) blockers

4.8 - Adverse effects (undesirable effects)

  • Updated common adverse reactions

19 July 2023

ropinirole hydrochloride

Appese

Repreve

Arrow Pharma Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Spontaneous penile erection
  • Hiccups

3 July 2023

ruxolitinib (as phosphate)

Jakavi

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Increased risk of major adverse cardiovascular events, thrombosis and secondary malignancies in patients with rheumatoid arthritis
  • Diverticulitis and gastrointestinal perforations with JAK inhibitors

4.8 - Adverse effects (undesirable effects)

  • Diverticulitis

3 July 2023

telmisartan/amlodipine

Twynsta

Pritor/Amlodipine

Boehringer Ingelheim Pty Ltd

4.9 - Overdose

  • Risk of non-cardiogenic pulmonary oedema due to amlodipine overdose

13 July 2023

triptorelin (as embonate)

Diphereline

Ipsen Pty Ltd

4.4 - Special warnings and precautions for use

  • Metabolic changes (e.g. glucose intolerance, fatty liver)

30 June 2023

zolpidem tartrate

Somidem

Alphapharm Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added double vision and vertigo
  • Updated frequency of ataxia and confusion

7 July 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 [email protected].

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 [email protected].

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For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance Branch at [email protected].

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