TGA Product Information safety updates 24 July

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 (sections updated and summary of key information)Date of approval

alendronate sodium colecalciferol

Fosamax Plus

Organon Pharma Pty Ltd

4.4 - Special warnings and precautions for use

  • Updated warning about atypical stress fractures

26 May 2023

atezolizumab

Tecentriq

Roche Products Pty Ltd

4.4 - Special warnings and precautions for use

  • Autoimmune haemolytic anaemia (AIHA)

4.8 - Adverse effects (undesirable effects)

  • Scrotal dermatitis, autoimmune haemolytic anaemia (AIHA) and systemic inflammatory response syndrome (SIRS)

29 June 2023

azithromycin dihydrate

Zithromax

Zithromax IV

Pfizer Australia Pty Ltd

4.2 - Dose and method of administration

4.4 - Special warnings and precautions for use

5.2 - Pharmacokinetic properties

  • Updated use in renal impairment

4.6 - Fertility, pregnancy and lactation

  • Warning about use in pregnancy

19 June 2023

carbamazepine

Tegretol

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Updated warning about hypersensitivity

4.5 - Interactions with other medicines and other forms of interactions

  • Brivaracetam

4.6 - Fertility, pregnancy and lactation

  • Risk of neurodevelopmental disorders

6 June 2023

fentanyl

Durogesic

Janssen-Cilag Pty Ltd

4.9 - Overdose

  • Toxic leukoencephalopathy

6 June 2023

flucloxacillin (as sodium)

Flucil

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Use in renal impairment

4.8 - Adverse effects (undesirable effects)

  • Erthyma nodosum, micturation, malaise, bad taste, sore throat, sore tongue, pruritus vulvae, arthralgia, dizziness, depression, headache, haemolytic anaemia

23 June 2023

fluticasone furoate

Arnuity Ellipta

GlaxoSmithKline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria
  • Dysphonia

15 June 2023

fluticasone furoate/ umeclidinium (as bromide)/ vilanterol (as trifenatate)

Trelegy Ellipta

GlaxoSmithKline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Hyperglycaemia
  • Anxiety
  • Tremor
  • Intraocular pressure increased
  • Palpitations
  • Muscle spasms

14 June 2023

guanfacine (as hydrochloride)

Intuniv

Takeda Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Hallucination

26 June 2023

lanreotide acetate

Somatuline Autogel

Ipsen Pty Ltd

4.4 - Special warnings and precautions for use

  • Pancreatic function warning

4.8 - Adverse effects (undesirable effects)

  • Pancreatic exocrine insufficiency

1 June 2023

mesalazine

Asacol

Chiesi Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Discolouration of urine after contact with sodium hypochlorite

4.8 - Adverse effects (undesirable effects)

  • Severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)

27 June 2023

methylphenidate hydrochloride

Concerta

Janssen-Cilag Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Epistaxis
  • Gynecomastia

15 June 2023

naltrexone hydrochloride plus bupropion hydrochloride

Contrave 8/90

iNova Pharmaceticals (Australia) Pty Ltd

4.4 - Special warnings and precautions for use

  • Brugada syndrome

29 June 2023

naproxen sodium

Anaprox

Atnahs Pharma Australia Pty Ltd

4.3 - Contraindications

  • Third trimester pregnancy

4.6 - Fertility, pregnancy and lactation

  • Updated information about use in pregnancy and risk of oligohydramnios and neonatal renal impairment with NSAID use

2 June 2023

nexviazyme

Nexviazyme

Sanofi-Aventis Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Hypoxia, tongue oedema and erythema

22 June 2023

olanzapine

Zyprexa

Eli Lilly Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Somnambulism (sleepwalking) and sleep-related eating disorder

21 June 2023

olanzapine pamoate monohydrate

Zyprexa Relprevv

Eli Lilly Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Somnambulism (sleepwalking) and sleep-related eating disorder

21 June 2023

omeprazole (as magnesium)

Acimax

Losec

Omepral

Pharmaco Australia Ltd

4.4 - Special warnings and precautions for use

  • Renal impairment warning

4.8 - Adverse effects (undesirable effects)

  • Updated tubulointerstitial nephritis

22 June 2023

oxycodone hydrochloride plus naloxone hydrochloride dihydrate

Targin

Mundipharma Pty Ltd

4.2 - Dose and method of administration

4.4 - Special warnings and precautions for use

  • Guidance on initiation, monitoring and discontinuing treatment
  • Effects on sphincter of Oddi and intrabiliary pressure

4.8 - Adverse effects (undesirable effects)

  • Sphincter of Oddi dysfunction
  • Updated frequency: drug withdrawal syndrome, drug dependence, sleep apnoea syndrome
  • Drug dependence

4.9 - Overdose

  • Toxic leukoencephalopathy observed

27 June 2023

paliperidone palmitate

Invega Hafyera

Invega Trinza

Invega Sustenna

Janssen-Cilag Pty Ltd

4.2 - Dose and method of administration

  • Updated Instructions for Use

8 June 2023

paracetamol and ibuprofen sodium dihydrate

Maxigesic IV

AFT Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

4.8 - Adverse effects (undesirable effects)

  • Drug reaction with eosinophilia and systemic symptoms (DRESS)

26 June 2023

remdesivir

Veklury

Gilead Sciences Pty Ltd

4.4 - Special warnings and precautions for use

  • Administration site extravasation

29 June 2023

trimethoprim/ sulfamethoxazole

Septrin Forte

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

  • Acute Respiratory Distress Syndrome (ARDS)

31 May 2023

umeclidinium (as bromide)/ vilanterol (as trifenatate)

Anoro Ellipta

GlaxoSmithKline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Headache

31 May 2023

umeclidinium bromide

Incruse Ellipta

GlaxoSmithKline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Dysphonia
  • Oropharyngeal pain

16 June 2023

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

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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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