Product Information safety updates - September and October 2022

Medicines Safety Update

Published

1 November 2022

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:

reports of adverse events
Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs)
reviews of literature
sharing of information with other regulatory agencies
sharing of information with Australian state and territory health authorities.

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 Medicines Safety Update 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
abacavir sulfate, lamuvidine, zidovudine	Trizivir ViiV Healthcare Pty Ltd	4.4 – Special warnings and precautions for use Updated warning and haematological precautions relating to zidovudine in patients with moderate renal impairment	1 August 2022
acetazolamide	Diamox Arrow Pharma Pty Ltd	4.3 – Contraindications Severe glaucoma 4.4 – Special warnings and precautions for use ‘Nervous’ section and other updates 4.5 – Interactions with other medicines and other forms of interactions Update to primidone 4.6 – Fertility, pregnancy and lactation Embryotoxic warning in Use in Pregnancy 4.8 – Adverse effects (undesirable effects)	27 June 2022
Ad26.COV2.S	COVID-19 Vaccine Janssen Janssen-Cilag Pty Ltd	4.4 – Special warnings and precautions for use Further information on management of individuals with suspected thrombosis with thrombocytopenia syndrome	17 August 2022
American house dust mite extract and European house dust mite extract	Acarizax Seqirus Pty Ltd	4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects) Eosinophilic oesophagitis	21 July 2022
amlodipine besilate and telmisartan	Twynsta and Pritor/ Amlodipine Boehringer Ingelheim Pty Ltd	4.4 – Special warnings and precautions for use Strengthened warning on dual blockade of the renin-angiotension-aldosterone system 4.8 – Adverse effects (undesirable effects) Hyponatraemia for telmisartan as monotherapy, and other adverse effects for telmisartan and amlodipine as monotherapy 4.9 – Overdose Telmisartan not dialysable and not removed from blood by haemofiltration 6.4 – Special Precautions for Storage	8 July 2022
amoxicillin and clavulanic acid	Augmentin Duo 400 Augmentin Duo Augmentin Duo Forte Aspen Pharmacare Australia Pty Ltd	4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects) Kounis syndrome	18 July 2022
apomorphine hydrochloride hemihydrate	Apomine Pfizer Australia Pty Ltd	4.2 – Dose and method of administration 4.3 – Contraindications Children under 18 4.4 – Special warnings and precautions for use Risk factors for QT interval prolongation Use in debilitated patients 4.5 – Interactions with other medicines and other forms of interactions Neuroleptic medicinal products 4.7 – Effects on ability to drive and use machines 4.8 – Adverse effects (undesirable effects)	4 July 2022
azacitidine	Vidaza Aspen Pharmacare Australia Pty Ltd	4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects) Differentiation syndrome (also known as retinoic acid syndrome)	19 July 2022
betamethasone valerate	Celestone M Organon Pharma Pty Ltd	4.6 – Fertility, pregnancy and lactation Pregnancy category changed from A to B3	21 July 2022
bimatoprost	Lumigan/ Lumigan PF Allergan Australia Pty Ltd	4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects) Prostaglandin analogue periorbitopathy (PAP)	1 August 2022
bimatoprost and timolol maleate	Ganfort / Ganfort PF Allergan Australia Pty Ltd	4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects) Prostaglandin analogue periorbitopathy (PAP)	2 August 2022
capecitabine	Capecitabine Sandoz Sandoz Pty Ltd	4.4 – Special warnings and precautions for use Expanded warning on dihydropyrimidine dehydrogenase (DPD) deficiency and 5-fluorouracil toxicity	5 July 2022
capecitabine	Xelabine Viatris Pty Ltd	4.4 – Special warnings and precautions for use Expanded warning on dihydropyrimidine dehydrogenase (DPD) deficiency and 5-fluorouracil toxicity	15 July 2022
capecitabine	Capecitabine-DRLA Dr Reddy's Laboratories Australia Pty Ltd	4.4 – Special warnings and precautions for use Strengthened warning on dihydropyrimidine dehydrogenase (DPD) deficiency	5 August 2022
carboplatin	DBL Carboplatin Pfizer Australia Pty Ltd	4.4 – Special warnings and precautions for use Strengthened toxicity warning Expanded warnings for bone marrow function, renal impairment, auditory monitoring 4.5 – Interactions with other medicines and other forms of interactions 4.6 – Fertility, pregnancy and lactation 4.8 – Adverse effects (undesirable effects) Expanded blood and lymphatic system disorders adverse reactions Expanded GI disorders adverse reactions	29 August 2022
ChAdOx1-S	Vaxzevria AstraZeneca Pty Ltd	4.8 – Adverse effects (undesirable effects) Tinnitus	25 July 2022
ciclosporin	Ikervis Seqiruis Pty Ltd	4.4 – Special warnings and precautions for use Recommendation for regular eye tests	17 August 2022
ciprofloxacin	Ciprofloxacin Sandoz Sandoz Pty Ltd	4.8 – Adverse effects (undesirable effects) Drug reaction with eosinophilia and systemic symptoms (DRESS)	25 July 2022
ciprofloxacin	Ciprofloxacin GH Generic Health Pty Ltd Noumed ciprofloxacin Avallon Pharmaceuticals Pty Ltd Ciprol / Apo-ciprofloxacin Apotex Pty Ltd C-Flox Alphapharm Pty Ltd	4.8 – Adverse effects (undesirable effects) Drug reaction with eosinophilia and systemic symptoms (DRESS)	4 August 2022
cladribine	Mavenclad Merck Healthcare Pty Ltd	4.6 – Fertility, pregnancy and lactation Advice for patients not to lactate for one week after the last dose 4.8 – Adverse effects (undesirable effects) Liver injury	14 July 2022
clomifene citrate	Clomid Sanofi-Aventis Australia Pty Ltd	4.4 – Special warnings and precautions for use Partial or complete loss of vision and cases of irreversible visual disturbances, including after discontinuation 4.8 – Adverse effects (undesirable effects) Adverse effects relating to vision	4 August 2022
clopidogrel hydrogen sulfate	Iscover Clopidogrel Winthrop Plavix Sanofi-Aventis Australia Pty Ltd	4.4 – Special warnings and precautions for use Triple antiplatelet therapy (clopidogrel plus aspirin plus dipyridamole) for stroke secondary prevention in patients with acute non-cardioembolic ischemic stroke or transient ischaemic attack is not recommended due to the increased risk of haemorrhage	19 July 2022
dapagliflozin	Forxiga AstraZeneca Pty Ltd	4.5 – Interactions with other medicines and other forms of interactions Lithium	30 August 2022
dasatinib	Sprycel Bristol-Myers Squibb Australia Pty Ltd	4.4 – Special warnings and precautions for use Chylothorax in patients with pleural effusion 4.8 – Adverse effects (undesirable effects) Pleural effusion and chylothorax	15 July 2022
dimethyl fumarate	Tecfidera Biogen Australia Pty Ltd	4.8 – Adverse effects (undesirable effects) Serious opportunistic infections	26 July 2022
dinutuximab beta	Qarziba Link Medical Products Pty Ltd T/A Link Pharmaceuticals	4.8 – Adverse effects (undesirable effects) Oropharyngeal pain, injection site pain, bone pain and neck pain Updated the incidence data	31 August 2022
dobutamine hydrochloride	DBL Dobutamine Pfizer Australia Pty Ltd	4.3 – Contraindications Mechanical obstruction affecting left ventricular filling or outflow dose 4.4 – Special warnings and precautions for use Increases in pulmonary shunting Decreases blood pressure with therapy Added other information 4.5 – Interactions with other medicines and other forms of interactions Beta-adrenergic receptor agonists, glyceryl trinitrate and entacapone 4.6 – Fertility, pregnancy and lactation 4.7 – Effects on ability to drive and use machines 4.8 – Adverse effects (undesirable effects)	14 July 2022
elasomeran	Spikevax COVID-19 vaccine Moderna Australia Pty Ltd	4.4 – Special warnings and precautions for use Capillary leak syndrome (CLS) 4.8 – Adverse effects (undesirable effects) Acute and delayed urticaria	29 August 2022
enzalutamide	Xtandi Astellas Pharma Australia Pty Ltd	4.8 – Adverse effects (undesirable effects) Dysgeusia	4 August 2022
eptinezumab	Vyepti Lundbeck Australia Pty Ltd	4.8 – Adverse effects (undesirable effects) Infusion related reactions	27 June 2022
ethosuximide	Zarontin Clinect Pty Ltd	4.8 – Adverse effects (undesirable effects) Thrombocytopenia	23 August 2022
fluconazole	Diflucan Pfizer Australia Pty Ltd	4.4 – Special warnings and precautions for use Drug reaction with eosinophilia and systemic symptoms (DRESS) and candidiasis 4.5 – Interactions with other medicines and other forms of interactions DDIs with HMG COA reductase inhibitors, ivacaftor and lurasidone 4.8 – Adverse effects (undesirable effects) DRESS	1 August 2022
fluorouracil	DBL Fluorouracil injection Pfizer Australia Pty Ltd	4.4 – Special warnings and precautions for use Strengthened warning on dihydropyrimidine dehydrogenase (DPD) deficiency	4 August 2022
Fluticasone furoate with umeclidinium and vilanterol	Trelegy Ellipta GlaxoSmithKline Australia Pty Ltd	4.8 – Adverse effects (undesirable effects) Urinary retention and dysuria	16 August 2022
gemeprost	Cervagem Sanofi-Aventis Australia Pty Ltd	4.3 – Contraindications Updated warning not to use in women who have known hypersensitivity to any other ingredients Risk of haemorrhage due to procedures for placenta previa and ectopic pregnancy Fever due to pelvic infection 4.4 – Special warnings and precautions for use Reports of cervical laceration 4.8 – Adverse effects (undesirable effects) Unknown anaphylactic reaction incidence Added information on hypersensitivity-like reactions	2 August 2022
hydrochlorothiazide and enalapril	Renitec Plus Organon Pharma Pty Ltd	4.4 – Special warnings and precautions for use Acute respiratory distress syndrome (ARDS) and hydrochlorothiazide 4.8 – Adverse effects (undesirable effects) Respiratory distress, pneumonitis, pulmonary oedema and acute respiratory distress	23 August 2022
hydrochlorothiazide and olmesartan	Olmetec Plus Organon Pharma Pty Ltd	4.4 – Special warnings and precautions for use Acute respiratory distress syndrome (ARDS) and hydrochlorothiazide 4.8 – Adverse effects (undesirable effects) Autoimmune hepatitis relating to olmesartan Acute respiratory distress relating to hydrochlorothiazide	23 August 2022
hydrochlorothiazide irbesartan	Karvezide Sanofi-aventis Australia Pty Ltd	4.4 – Special warnings and precautions for use Reports of severe cases of acute respiratory toxicity 4.8 – Adverse effects (undesirable effects) Significant increase in blood creatine phosphokinase as a common adverse reaction	22 August 2022
hydrochlorothiazide, olmesartan and amlodipine	Sevikar HCT Organon Pharma Pty Ltd	4.4 – Special warnings and precautions for use Acute respiratory distress syndrome (ARDS) and hydrochlorothiazide 4.8 – Adverse effects (undesirable effects) Autoimmune hepatitis relating to olmesartan Acute respiratory distress relating to hydrochlorothiazide	23 August 2022
hydroxycarbamide (hydroxyurea)	Hydrea Link Medical Products Pty Ltd T/A Link Pharmaceuticals	4.6 – Fertility, pregnancy and lactation Female patients of reproductive potential should be counselled to use effective contraception including for at least 6 months after therapy	26 August 2022
hydroxychloroquine sulfate	Plaquenil Sanofi-Aventis Australia Pty Ltd	4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects) Severe cutaneous adverse reactions (SCARs) 4.4 – Special warnings and precautions for use 4.5 – Interactions with other medicines and other forms of interactions 4.8 – Adverse effects (undesirable effects) Hepatic disorders	21 July 2022
imatinib	Glivec Novartis Pharmaceuticals Australia Pty Ltd	4.8 – Adverse effects (undesirable effects) Panniculitis (including erythema nodosum)	27 July 2022
ipratropium bromide monohydrate	Atrovent Boehringer Ingelheim Pty Ltd	4.4 – Special warnings and precautions for use Alcohol content	17 August 2022
irbesartan	Karvea Sanofi-aventis Australia Pty Ltd	4.8 – Adverse effects (undesirable effects) Significant increase in blood creatine phosphokinase	19 August 2022
lamivudine/ zidovudine	Combivir ViiV Healthcare Pty Ltd	4.4 – Special warnings and precautions for use Haematological monitoring in patients with moderate renal impairment	22 July 2022
levothyroxine	Eltroxin Aspen Pharma Pty Ltd	4.4 – Special warnings and precautions for use Risk of circulatory collapse in preterm neonates	14 July 2022
linezolid	Zyvox Pfizer Australia Pty Ltd	4.4 – Special warnings and precautions for use Updated warning to include risk factors of moderate to severe hepatic impairment and severe renal insufficiency associated with thrombocytopenia, and blood monitoring for patients who receive concomitant medications that may decrease haemoglobin levels or platelet count or function	22 June 2022
liraglutide	Victoza Saxenda Novo Nordisk Pharmaceuticals Pty Ltd	4.2 – Dose and method of administration 4.8 – Adverse effects (undesirable effects) Cutaneous amyloidosis	24 August 2022
meropenem	Meropenem Juno Juno Pharmaceuticals Pty Ltd	4.8 – Adverse effects (undesirable effects) Renal impairment	19 August 2022
methadone hydrochloride	Biodone Forte Biomed Australia Pty Ltd	4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects) 4.9 – Overdose Hypoglycaemia	15 August 2022
mifepristone	Mifepristone Linepharma MS Health Pty Ltd	4.3 – Contraindications Use in pregnancy not confirmed by ultrasound or biological test, such as urine or serum HCG 4.4 – Special warnings and precautions for use Further information on management of suspected acute adrenal failure 4.8 – Adverse effects (undesirable effects) Arrhythmia	10 August 2022
mifepristone and misoprostol (composite pack)	MS-2 Step MS Health Pty Ltd	4.3 – Contraindications Use in pregnancy not confirmed by ultrasound or biological test, such as urine or serum HCG Asthma uncontrolled by therapy 4.4 – Special warnings and precautions for use Further information on management of suspected acute adrenal failure Risk of angioedema and anaphylaxis related to misoprolol administration Removal of intrauterine devices prior to administration of mifepristone Increased risk of fetus developing Moebius syndrome, amniotic band syndrome and/or central nervous system abnormalities 4.6 – Fertility, pregnancy and lactation Increased risk of birth defects/malformations for ongoing pregnancies 4.8 – Adverse effects (undesirable effects) Arrhythmia and fetal malformations	23 August 2022
naltrexone/ bupropion	Contrave 8/90 iNova Pharmaceuticals (Australia) Pty Ltd	4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects) Panic attack	31 August 2022
olmesartan medoxomil	Olmetec/ Olmesartan-MYL Organon Pharma Pty Ltd	4.8 – Adverse effects (undesirable effects) Autoimmune hepatitis	15 August 2022
olmesartan medoxomil and amlodipine besilate	Sevikar/ Olmesartan/Amlodipine-MYL Organon Pharma Pty Ltd	4.8 – Adverse effects (undesirable effects) Autoimmune hepatitis	15 August 2022
pantoprazole (as sodium sesquihydrate)	Somac Takeda Pharmaceuticals Australia Pty Ltd	4.4 – Special warnings and precautions for use Severe cutaneous adverse reactions (SCARs) 4.8 – Adverse effects (undesirable effects) Acute generalised exanthematous pustulosis	10 August 2022
pegvaliase	Palynziq BioMarin Pharmaceutical Australia Pty Ltd	4.8 – Adverse effects (undesirable effects) Dizziness Dyspnoea as a symptom of hypersensitivity reaction	9 August 2022
pembrolizumab	Keytruda Merck Sharp & Dohme (Australia) Pty Ltd	5.1 – Pharmacodynamic properties Updated information on early deaths followed by overall survival benefit seen in clinical trials	19 August 2022
quinapril	Accupril Pfizer Australia Pty Ltd	4.4 – Special warnings and precautions for use Consider discontinuing if clinically significant psoriasis or psoriasis aggravation occurs 4.8 – Adverse effects (undesirable effects) Psoriasis	24 August 2022
quinapril hydrochloride/ hydrochlorothiazide	Accuretic Pfizer Australia Pty Ltd	4.4 – Special warnings and precautions for use Acute respiratory distress syndrome (ARDS) with hydrochlorothiazide Psoriasis or aggravation of psoriasis in people taking ACE inhibitors 4.8 – Adverse effects (undesirable effects) Psoriasis	22 July 2022
raltegravir	Isentress Merck Sharp & Dohme (Australia) Pty Ltd	4.4 – Special warnings and precautions for use 4.5 – Interactions with other medicines and other forms of interactions Iron salts resulting in reduced plasma levels of raltegravir on co-administration	18 July 2022
ramucirumab	Cyramza Eli Lilly Australia Pty Ltd	4.4 – Special warnings and precautions for use Added information on heart failure	23 August 2022
ranibizumab (rbe)	Lucentis Novartis Pharmaceuticals Australia Pty Ltd	4.6 – Fertility, pregnancy and lactation Lactation recommendation revised	4 July 2022
ravuizumab	Ultomiris Alexion Pharmaceuticals Australasia Pty Ltd	4.8 – Adverse effects (undesirable effects) Urticaria	12 July 2022
rosuvastatin calcium	Crestor A Menarini Australia Pty Ltd	4.5 – Interactions with other medicines and other forms of interactions Protease inhibitors, regorafenib, darolutamide, fostamatinib, capmatinib, febuxostat and teriflunomide 4.8 – Adverse effects (undesirable effects) Added information on drug reaction with eosinophilia and systemic symptoms (DRESS)	29 August 2022
secukinumab	Cosentyx Novartis Pharmaceuticals Australia Pty Ltd	4.8 – Adverse effects (undesirable effects) Hypersensitivity vasculitis	19 August 2022
selexipag	Uptravi Janssen-Cilag Pty Ltd	4.2 – Dose and method of administration Recommendation that, at the beginning of treatment and at each up-titration step, take the first dose in the evening 4.8 – Adverse effects (undesirable effects Results from the TRITON clinical study	26 August 2022
sodium valproate	Epilim Sanofi-Aventis Australia Pty Ltd	4.3 – Contraindications Carnitine deficiency 4.4 – Special warnings and precautions for use Warning in paediatric population for treatment of manic episodes, mitochondrial disorders, urea cycle disorders, hyperammonemia and hypocarnitinemia 4.5 – Interactions with other medicines and other forms of interactions Methotrexate and pivalate-conjugated medicines 4.6 – Fertility, pregnancy and lactation 4.8 – Adverse effects (undesirable effects) 4.9 – Overdose 5.2 – Pharmacokinetic properties	30 August 2022
spironolactone	Aldactone Pfizer Australia Pty Ltd	4.5 – Interactions with other medicines and other forms of interactions Increased prostate specific antigen (PSA) levels during abiraterone treatment in prostate cancer patients	27 July 2022
sulfamethoxazole trimethoprim	DBL Sulfamethoxazole 400 Mg and Trimethoprim 80 Mg Pfizer Australia Pty Ltd	4.4 – Special warnings and precautions for use 4.8 – Adverse effects (undesirable effects) Haemophagocytic lymphohistiocytosis (HLH)	23 August 2022
telmisartan and hydrochlorothiazide	Micardis Plus Boehringer Ingelheim Pty Ltd	4.2 – Dose and method of administration Caution with hepatic impairment 4.4 – Special warnings and precautions for use Strengthened warnings on dual blockade of the renin-angiotension-aldosterone system, sodium and/ or volume-depleted patients, and electrolyte imbalance 4.5 – Interactions with other medicines and other forms of interactions 4.8 – Adverse effects (undesirable effects) Hyponatraemia for telmisartan as monotherapy Acute myopia for hydrochlorothiazide as monotherapy 4.9 – Overdose Telmisartan not dialysable and not removed from blood by haemofiltration 6.4 – Special Precautions for Storage	8 July 2022
tocilizumab	Actemra Roche Products Pty Ltd	4.8 – Adverse effects (undesirable effects) Pancreatitis	30 August 2022
trastuzumab emtansine	Kadcyla Aspen Pharmacare Australia Pty Ltd	4.4 – Special warnings and precautions for use Updated warning as cases of severe and prolonged thrombocytopenia reported	18 July 2022
tretinoin	Vesanoid Pharmaco Australia Pty Ltd	4.8 – Adverse effects (undesirable effects) Pericarditis and myocarditis	13 July 2022
trihexyphenidyl (benzhexol) hydrochloride	Artane Arrow Pharma Pty Ltd	– Special warnings and precautions for use Increased warning with myasthenia gravis Psychiatric adverse effects 4.5 – Interactions with other medicines and other forms of interactions Increased information on drug-drug interactions with other anticholinergic agents and prokinetic drugs Concurrent use with patients already receiving tricyclic antidepressants or monoamine oxidase inhibitors 4.8 – Adverse effects (undesirable effects) Additional adverse events under various sub-headings	15 July 2022
vildagliptin	Galvus Novartis Pharmaceuticals Australia Pty Ltd	4.8 – Adverse effects (undesirable effects) Cutaneous vasculitis	27 July 2022
vildagliptin/ metformin hydrochloride	Galvumet Novartis Pharmaceuticals Australia Pty Ltd	4.8 – Adverse effects (undesirable effects) Cutaneous vasculitis	21 July 2022
zopiclone	Pharmacor Zopiclone Pharmacor Pty Ltd	4.1 – Therapeutic indications 4.2 – Dose and method of administration Treatment period updated from ‘2 to 4 weeks’ to ‘7 – 14 days’ 4.4 – Special warnings and precautions for use 4.6 – Fertility, pregnancy and lactation 4.8 – Adverse effects (undesirable effects) Delirium 6.5 – Nature and contents of container	30 August 2022

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.

Reports may be submitted:

online at www.tga.gov.au
by fax to 02 6232 8392
by email to ADR.Reports@tga.gov.au

For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.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.

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 and Special Access Branch at ADR.Reports@tga.gov.au.

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Product Information safety updates - September and October 2022

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

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