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Product Information safety updates - February 2024

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

Date of approval

allopurinol

Zyloprim 

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

  • Added advice for treatment during acute gout attacks.

4.5 - Interactions with other medicines and other forms of interactions

  • Updated warning about 6-mercaptopurine and azathioprine. 
  • Updated warning about coumarin anticoagulants.

4.8 - Adverse effects (undesirable effects)  

  • Stevens‐Johnson syndrome and toxic epidermal necrolysis (SJS/TEN)

22 January 2024

apomorphine hydrochloride hemihydrate

Movapo 

 Pharmaceuticals Australia Pty Ltd

4.3 - Contraindications  

4.5 - Interactions with other medicines and other forms of interactions  

  • contraindication for 5HT3 antagonists including antiemetics (for example ondansetron, granisetron, palonosetron)

5 January 2024

azacitidine

Vidaza 

Celgene Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • cutaneous vasculitis 

11 January 2024

belzutifan

Welireg 

Merck Sharp & Dohme (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects) 

  • increased weight

24 January 2024

bosentan monohydrate

Tracleer 

Janssen-Cilag Pty Ltd

4.6 - Fertility, pregnancy, and lactation

  • Update to Use in lactation section.

24 January 2024

carbidopa monohydrate/levodopa

Kinson 

Alphapharm Pty Ltd

4.4 - Special warnings and precautions for use

  • dopamine dysregulation syndrome (DDS), ulcer diseases and haematemesis  

4.5 - Interactions with other medicines and other forms of interactions

  • anticholinergics, benzodiazepine, sympathomimetic medication

4.8 - Adverse effects (undesirable effects)

  • UTI, dopamine dysregulation syndrome (DDS), breast pain

31 January 2024

cariprazine hydrochloride

Reagila 

Gedeon Richter Australia Pty Ltd

4.8 - Adverse effects (undesirable effects) 

  •  Stevens-Johnson syndrome 

11 January 2024

cefaclor monohydrate

Ceclor

Viatris Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘neurotoxicity’. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Withdrawal of medicine should be considered if there are signs of neurotoxicity. 

4.8 - Adverse effects (undesirable effects)

  • Added subheading ‘Nervous system disorders’ under ‘Post-marketing experience’. Added seizures, encephalopathy and/or myoclonus.

18 January 2024

cefalexin monohydrate 

 

 

 

 

Keflex

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘neurotoxicity’. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Withdrawal of medicine should be considered if there are signs of neurotoxicity. 

4.8 - Adverse effects (undesirable effects)

  • Subheading ‘Nervous System Disorders’. Added encephalopathy, myoclonus (frequency not known). 

8 January 2024

cefazolin sodium

Cefazolin-Aft

Aft Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘neurotoxicity’. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Withdrawal of medicine should be considered if there are signs of neurotoxicity. 

4.8 - Adverse effects (undesirable effects)

  • Added subheading ‘Nervous system disorders’ under ‘Post-marketing experience’. Added seizures, encephalopathy, myoclonus. 

15 January 2024

cefotaxime

DBL Cefotaxime sodium 

Pfizer Australia Pty Ltd

4.8 - Adverse effects (Undesirable effects) 

  • kounis syndrome

23 January 2024

ceftazidime pentahydrate

Ceftazidime Viatris

Alphapharm Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘neurotoxicity’. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Withdrawal of medicine should be considered if there are signs of neurotoxicity. 

17 January 2024

ceftazidime pentahydrate

Ceftazidime-Aft

Aft Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘neurotoxicity’. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Withdrawal of medicine should be considered if there are signs of neurotoxicity. 
    1. - Special warnings and precautions for use

22 January 2024

ceftazidime pentahydrate 

Ceftazidime Kabi

Fresenius Kabi Australia Pty Limited

  • Added subheading ‘neurotoxicity’. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Withdrawal of medicine should be considered if there are signs of neurotoxicity. 

29 January 2024

ceftolozane sulfate / tazobactam sodium 

Zerbaxa 

Merck Sharp & Dohme (Australia) Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘neurotoxicity’. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Withdrawal of medicine should be considered if there are signs of neurotoxicity. 

4.8 - Adverse effects (undesirable effects)

  • Added post marketing reports of neurotoxicity (including seizure, encephalopathy, myoclonus). 

31 January 2024

ceftriaxone sodium

Ceftriaxone-Aft 

Aft Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘neurotoxicity’. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Withdrawal of medicine should be considered if there are signs of neurotoxicity. 

4.8 - Adverse effects (undesirable effects)

  • Subheading ‘Post Marketing Experience’. Added nervous system disorders: encephalopathy, myoclonus – frequency not known.

11 January 2024

ceftriaxone sodium

Ceftriaxone Viatris

Alphapharm Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘neurotoxicity’. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Withdrawal of medicine should be considered if there are signs of neurotoxicity. 

4.8 - Adverse effects (undesirable effects)

  • Subheading ‘Post Marketing Experience’. Added nervous system disorders: encephalopathy, myoclonus – frequency not known.

12 January 2024

cefuroxime axetil

Zinnat Tablet 

Zinnat Suspension

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘neurotoxicity’. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Withdrawal of medicine should be considered if there are signs of neurotoxicity. 

4.8 - Adverse effects (undesirable effects)

  • Subheading ‘CNS’. Added encephalopathy, myoclonus – frequency not known.

9 January 2024

cefuroxime sodium

Cefuroxime Sxp

Southern Xp Ip Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘neurotoxicity’. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Withdrawal of medicine should be considered if there are signs of neurotoxicity. 

4.8 - Adverse effects (undesirable effects)

  • Subheading ‘Nervous System Disorders’. Added encephalopathy, myoclonus (frequency not known).

17 January 2024

cephazolin sodium

Cephazolin Viatris

Alphapharm Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘neurotoxicity’. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Withdrawal of medicine should be considered if there are signs of neurotoxicity. 

4.8 - Adverse effects (undesirable effects)

  • Added subheading ‘Nervous system disorders’ under ‘Post-marketing experience’. Added seizures, encephalopathy, myoclonus – frequency not known.  

19 January 2024

clomifene citrate

Clomid 

Sanofi-Aventis Australia Pty Ltd

4.3 - Contraindications 

  • Added history of significant, medically confirmed, vision disorders related to the use of Clomid (prior or ongoing treatment).

25 January 2024

conjugated estrogens / bazedoxifene acetate

Duavive 0.45/20 

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use  

  • acquired angioedema added to existing warnings for hereditary angioedema 

4.8 - Adverse effects (undesirable effects)  

  • hereditary and acquired angioedema

16 January 2024

diazoxide

DBL Diazoxide 

Pfizer Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • pericardial effusion

9 January 2024

epoprostenol sodium

Veletri 

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use

  • Added warning about ascites.

5 January 2024

esketamine hydrochloride

Spravato 

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use  

  • Added warning about respiratory depression.

4.8 - Adverse effects (undesirable effects)

  • respiratory depression as post-marker adverse event

16 January 2024

Factor VIII inhibitor bypassing fraction

Feiba-NF 

Takeda Pharmaceuticals

4.3 – Contraindications

  • Added myocardial infarction.

4.4 - Special warnings and precautions for use

  • no direct monitoring of active ingredient available

4.5 - Interactions with other medicines and other forms of interactions

  • Added sequential use of rFVIIa.

4.6 - Fertility, pregnancy and lactation

  • Expanded precaution about use in lactation.

4.8 - Adverse effects (undesirable effects)

  • Fibrin D-dimer increased

24 January 2024

flutamide

Flutamin 

Alphapharm Pty Ltd

4.8 - Adverse effects (undesirable effects) 

  • hypertension 
  • QT interval prolongation 

22 January 2024

glibenclamide/ metformin hydrochloride

Glucovance 

Alphapharm Pty Ltd

4.4 - Special warnings and precautions for use 

  • Added risk vitamin B12 deficiency.

4.8 - Adverse effects (undesirable effects) 

  • Updated information about vitamin B12 deficiency.

15 January 2024

hydroxychloroquine sulfate

Plaquenil 

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • aggravation of myasthenia gravis

11 January 2024

mercaptopurine monohydrate 

Allmercap

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

4.4 - Special warnings and precautions for use

  • Added subheading ‘Hypoglycaemia’. Cases of symptomatic hypoglycaemia have been reported. Majority of cases were in children under the age of six or with low body mass index. 

15 January 2024

mercaptopurine monohydrate 

Mercaptopurine-Link

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

4.4 - Special warnings and precautions for use

  • Subheading ‘Paediatric use’. Cases of symptomatic hypoglycaemia have been reported. Majority of cases were in children under the age of six or with low body mass index.

4.8 - Adverse effects (undesirable effects)

  • Added hypoglycaemia in the paediatric population – frequency unknown. 

15 January 2024

meropenem

Merrem 

Pfizer Australia Pty Ltd

4.8 - Adverse effects (undesirable effects) 

  • kounis syndrome

23 January 2024

methotrexate

Chexate  

Orion Pharma (AUS) Pty Limited

4.4 - Special warnings and precautions for use

  • warning about photosensitivity

4.8 - Adverse effects (undesirable effects)

  • oedema
  • peripheral oedema
  • pulmonary oedema
  • brain oedema

2 January 2024

methylphenidate hydrochloride

Ritalin and Ritalin LA 

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • acute angle closure glaucoma
  • increased intraocular pressure and glaucoma

4.8 - Adverse effects (undesirable effects)

  • Added multiple adverse events from spontaneous reports and literature.
  • epistaxis

30 January 2024

methylprednisolone acetate

Depo-Medrol

Depo-Nisolone            

Pfizer Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • flushing
  • Updated information about post-injection pain flare.

15 January 2024

osimertinib mesilate

Tagrisso 

AstraZeneca Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • skin hyperpigmentation

29 January 2024

perflutren

Definity 

Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific

4.4 - Special warnings and precautions for use  

4.8 - Adverse effects (undesirable effects)  

  • acute pain episodes and vaso-occlusive crisis in patients with sickle cell disease

23 January 2024

phenobarbital sodium

Phenobarbitone injection 

Aspen Pharmacare Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • gingival enlargement

4 January 2024

ponesimod

Ponvory 

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use

  • Updated warnings for progressive multifocal leukoencephalopathy (PML) with immune reconstitution inflammatory syndrome (IRIS).

4 January 2024

rituximab

Truxima

Celltrion Healthcare Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘enteroviral meningoencephalitis’. Cases of enteroviral meningoencephalitis, including fatal cases, have been reported. Physicians should consider enteroviral meningoencephalitis in differential diagnosis of patients reporting symptoms such as fever, headache, stiff neck, ataxia, psychiatric symptoms, seizure, altered consciousness or coma. 

4.8 - Adverse effects (undesirable effects)

  • Added enteroviral meningoencephalitis. 

8 December 2023

sacituzumab govitecan

Trodelvy

Gilead Sciences Pty Ltd

4.4 - Special warnings and precautions for use

  • Subheading ‘Hypersensitivity’. Added severe signs and symptoms include cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reaction. 

22 December 2023

sulfamethoxazole/ trimethoprim

tablets

Bactrim DS 

Echo Therapeutics Pty Ltd

4.4 - Special warnings and precautions for use 

  • Added warning about haemophagocytic lymphohistiocytosis (HLH).

4.8 - Adverse effects (undesirable effects) 

  • urolithiasis

12 January 2024

sulfamethoxazole/ trimethoprim 

Infusion for injection 

Bactrim 400/80 

Echo Therapeutics Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • urolithiasis

12 January 2024

tazobactam sodium piperacillin sodium

Tazocin EF 

Pfizer Australia Pty Ltd

4.8 - Adverse effects (undesirable effects) 

  • kounis syndrome

11 January 2024

teduglutide

Revestive 

Takeda Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added recommendation for additional monitoring (upper GI endoscopy).

31 January 2024

zolpidem tartrate

Stilnox and Stilnox CR 

Sanofi-Aventis Australia Pty Ltd

4.4 Special warnings and precautions for use 

  • Warning about chemical submission.

3 January 2024

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