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Medicines Safety Update
Medicines Safety Update (MSU) provides health professionals with practical information and advice on drug safety and information about emerging safety issues. The articles also provide information on adverse event reporting and how health professionals can contribute to safety monitoring in Australia. MSU replaced the Australian Adverse Drug Reactions Bulletin in 2010.
Beginning in 2019, MSU articles are published as soon as relevant topics arise (rather than in a bimonthly scheduled publication, as was previously the case).
Health professionals and interested persons can subscribe and receive email notification when new articles are published.
- Product Information safety updates - June 2022
10 June 2022 The TGA has identified new safety information for medicines. The TGA has worked closely with sponsors of the medicine to update the Product Information (PI) to ensure consumers and health professionals are informed.
- Product Information safety updates - April 2022
22 April 2022 The TGA has identified new safety information for medicines. The TGA has worked closely with sponsors of the medicine to update the Product Information (PI) to ensure consumers and health professionals are informed.
- Clozapine and gastrointestinal hypomotility with severe complications
22 April 2022 The potentially fatal risk of gastrointestinal hypomotility in patients taking clozapine has been highlighted with a new boxed warning in the Product Information (PI) for this medicine.
- Donepezil and cardiac conduction disorders
28 February 2022 Cardiac conduction disorders have been reported in patients receiving donepezil. The Product Information (PI) documents for this medicine are being updated to advise caution in patients with known QTc prolongation or a family history of this condition.
- Administer vinca alkaloids by intravenous infusion only
24 February 2022 Unintended intrathecal injection of vinca alkaloids can result in fatal outcomes. To prevent this, the Product Information (PI) for vincristine, vinblastine and vinorelbine products has been changed to ensure these medicines are always given intravenously and by no other route.
- Ipilimumab and serous retinal detachment
18 February 2022 Treatment with ipilimumab has been linked to the rare yet serious adverse event of serous retinal detachment. The amount of photoreceptor degeneration and loss of vision can be minimised by early diagnosis and treatment.
- SGLT2 inhibitors approved for T2DM only
15 February 2022 Sodium glucose co-transporter 2 inhibitor products are approved for use in the management of type 2 diabetes mellitus - they are not approved for use in type 1 diabetes. Prescribers are reminded of the risk of diabetic ketoacidosis with the off-label use of these medicines.
- Clindamycin capsules and injections - acute kidney injury
3 February 2022 A new warning about the nephrotoxic potential of clindamycin capsules and injections has been added to the Australian Product Information (PI). This is not a previously known adverse event associated with this medicine. Health professionals should consider monitoring renal function for certain patients.
- Antidepressant use and youth suicide
20 January 2022 The TGA has continued its safety investigation of antidepressant use and the risk of suicide in young people. A recent NPS MedicineWise MedicineInsight analysis investigating antidepressant utilisation in young people attending general practice has been completed.
- Tenofovir alafenamide and renal adverse effects
6 January 2022 The Product Information (PI) for tenofovir alafenamide is being updated to include a warning about renal adverse effects. Health professionals should be aware of predisposing risk factors for these adverse effects and monitor patients appropriately.
- Ceftriaxone and risk of hepatitis and encephalopathy
15 December 2021 Health professionals are advised that the Product Information (PI) for ceftriaxone has been updated to include a warning about encephalopathy, particularly in older patients with underlying renal impairment or central nervous system disorders. Hepatitis has also been listed as a potential adverse event of ceftriaxone, along with encephalopathy.
- Octreotide and atrioventricular block
25 October 2021 The TGA is aware that, in Europe, atrioventricular blocks have been reported in patients receiving high doses of continuous intravenous infusion of octreotide and in patients receiving bolus octreotide intravenously.
- Pentosan polysulfate sodium and pigmentary maculopathy
11 October 2021 Health professionals are advised that the Product Information for pentosan polysulfate sodium has been updated with a warning about potential pigmentary maculopathy, especially after long-term use.
- Propylthiouracil and carbimazole – use in pregnancy
15 September 2021 Health professionals are advised that the pregnancy category for both propylthiouracil and carbimazole is being changed from category C to category D.
- Erenumab and hypertension
9 September 2021 Health professionals are advised that the Product Information (PI) for erenumab has been updated with a warning statement about a potential causal relationship between the drug and hypertension.
- Minocycline and agranulocytosis
30 August 2021 Health professionals are advised that the Product Information (PI) for minocycline is in the process of being updated to include information about agranulocytosis, a rare but potentially life-threatening adverse event.
- Parenteral iron products and foetal bradycardia/Kounis syndrome
26 July 2021 There are four parenteral iron products marketed in Australia. They are ferric carboxymaltose, iron polymaltose, ferric derisomaltose and iron sucrose.
- Nifedipine and pulmonary oedema when used in pregnancy
26 July 2021 The Product Information for nifedipine has been updated to provide new information about the risk of acute pulmonary oedema when used as a tocolytic agent (inhibiting myometrial smooth muscle contractions) for the treatment of preterm labor in pregnancy.
- Ocrelizumab and late onset neutropenia
26 July 2021 The Product Information for ocrelizumab has been updated to include a warning and further information about late onset neutropenia.
- Methylphenidate - use in pregnancy
22 July 2021 Health professionals are advised that the Product Information (PI) documents for methylphenidate products have been updated with new information about use in pregnancy.
- Bupropion and serotonin syndrome
2 July 2021 Health professionals are advised that the Product Information (PI) documents for bupropion-containing products have been updated to include a warning about the risk of serotonin syndrome when this drug is co-administered with other drugs known to be associated with serotonin syndrome, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs).
- Updated contraception advice for tamoxifen
23 June 2021 The recommended duration of contraception after finishing tamoxifen treatment has been extended from two months to nine months. This means women should continue their contraception and not become pregnant for at least nine months after tamoxifen therapy has ended.
- Sertraline and microscopic colitis
23 June 2021 Health professionals are advised that the Product Information (PI) documents for sertraline have been updated to include microscopic colitis as a potential adverse effect of unknown frequency based on post-marketing experience.
- Update - Dienogest and risk of venous thromboembolism
23 June 2021 Health professionals are advised that the Product information (PI) documents for combined oral contraceptives containing dienogest have been updated to include more detailed information on the risk of venous thromboembolism.
- Clonidine - importance of dosing compliance and safe storage
29 April 2021 Health professionals are reminded that serious adverse events can occur in children who are accidentally overdosed with clonidine either when receiving treatment for behavioural disorders, or obtaining access to a family member's medication.
- Water for injection and haemolysis
24 June 2020 Health professionals are reminded that water for injection can cause haemolysis resulting in patient harm, including death, if large quantities are inadvertently administered intravenously without being rendered isotonic.
- Ferric carboxymaltose and low blood phosphorous
27 February 2020 Health professionals are reminded that symptomatic hypophosphataemia is a known risk associated with use of ferric carboxymaltose and it is recommended that you routinely evaluate patient risk factors before commencing this medicine and follow up at-risk patients.
- Update - Fluoroquinolone antibiotics and adverse events
27 February 2020 Following the April 2019 MSU article regarding fluoroquinolone antibiotics and risk of aortic aneurysm/dissection, the Product Information (PI) for fluoroquinolone antibiotics have been updated to include more information about various potential adverse events.
- Update - Tocilizumab and hepatotoxicity
10 December 2019 Following the July 2019 MSU article regarding tocilizumab and hepatotoxicity, the Product Information (PI) for tocilizumab has been updated to include more information about this potential safety issue.
- Direct acting oral anticoagulants and risk of recurrent thrombotic events
26 August 2019 Health professionals are advised that the Product Information documents for direct acting oral anticoagulants registered in Australia are being updated to include new information about increased risk of recurrent thrombotic events in patients diagnosed with antiphospholipid syndrome.
- Tocilizumab and hepatotoxicity
11 July 2019 Health professionals are advised that serious drug-induced liver injury, including acute liver failure, hepatitis and jaundice, have been observed with the administration of tocilizumab. The frequency of serious hepatotoxicity is considered rare, but in some cases treatment has required liver transplant.
- Fluoroquinolone antibiotics and risk of aortic aneurysm/dissection
12 April 2019 The TGA is investigating a rare but serious adverse event of aortic aneurysm/dissection associated with fluoroquinolone antibiotics.
- Medicines Safety Update, Volume 9, Number 4, December 2018
Infliximab and mycosis fungoides, infliximab and lupus-like syndrome, and medicine shortages mandatory reporting
- Medicines Safety Update, Volume 9, Number 3, August-September 2018
New warning labels for neuromuscular blocking agents; local anaesthetic systemic toxicity; off-label use of atropine
- Medicines Safety Update, Volume 9, Number 2, June 2018
Misadventures in oral methotrexate dosing; Medicines associated with a risk of neuropsychiatric adverse events and Clozapine and gastrointestinal effects
- Medicines Safety Update, Volume 9, Number 1, February-March 2018
First-generation oral sedating antihistamines - use in children; Suvorexant (Belsomra) - next day effects; Desvenlafaxine (Pristiq) recommended dose; Miconazole and potential interaction with warfarin
- Medicines Safety Update, Volume 8, Number 5, October-November 2017
Ibrutinib - ventricular tachyarrhythmia, hepatitis B reactivation and infection; Improving Product Information; Codeine-containing products - use in children and ultra-rapid metabolisers
- Medicines Safety Update, Volume 8 Number 4, August-September 2017
Lithium level monitoring and toxicity; New precautions for hyoscine butylbromide ampoules; Off-label prescribing
- Medicines Safety Update, Volume 8, Number 3, June 2017
Intravenous solution bags, allergens, MedSearch app
- Medicines Safety Update, Volume 8, Number 2, April-May 2017
Viekira PAK and Viekira PAK-RBV - interaction with ethinyloestradiol; Ingenol mebutate - severe allergic reaction, herpes zoster and eye injury; Testosterone and arterial thromboembolism/venous thromboembolism
- Medicines Safety Update, Volume 8, Number 1, February 2017
Certain medicines and progressive multifocal leukoencephalopathy; Aripiprazole and impulse control disorders and Vemurafenib and risk of radiation injury
- Medicines Safety Update Volume 7 Number 5, October-December 2016
Combined hormonal contraceptives; antidepressants; adrenaline autoinjectors and advisory committees come to an end
- Medicines Safety Update, Volume 7, Number 4, August 2016
Bcr-Abl tyrosine kinase inhibitors and hepatitis B virus reactivation; Denosumab and QT prolongation; Isotretinoin and psychiatric adverse events and Medicine shortages information
- Medicines Safety Update Volume 7 Number 3, June 2016
Bromhexine-containing cough and cold medicines - risk of allergy and skin reactions; Lercanidipine and cloudy peritoneal effluent in patients on peritoneal dialysis; Medicine shortages information and Marcain Spinal 0.5% Heavy and reports of failed or incomplete spinal anaesthesia
- Medicines Safety Update, Volume 7, Number 2, April 2016
Updating medicine ingredient names; Xgeva and osteonecrosis of the jaw; erlotinib - change in indication; ibrutinib and hepatotoxicity
- Medicines Safety Update, Volume 7, Number 1, February 2016
Mycophenolate mofetil - contraindications relating to pregnancy and breastfeeding; Varenicline - risks of psychiatric symptoms and potential interaction with alcohol and Baclofen active pharmaceutical ingredient potential contamination
- Medicines Safety Update, Volume 6, Number 6, December 2015
TGA investigates proton pump inhibitors and increased cardiovascular risk; Potential interaction - allopurinol and 6-mercaptopurine/azathioprine; Intrauterine contraceptive devices and uterine perforation; Peginterferon alfa-2a and facial palsy
- Medicines Safety Update, Volume 6, Number 5, October 2015
Ustekinumab; sodium glucose co-transporter 2 inhibitors and diabetic ketoacidosis; and registering to report adverse events online
- Medicines Safety Update, Volume 6, Number 4, August 2015
Risperidone and risk of cerebrovascular adverse events; Infliximab and non-melanoma skin cancers; Tramadol oral drops
- Medicines Safety Update Volume 6 Number 3, June 2015
Methotrexate and hepatitis B reactivation; Ivabradine and cardiovascular events in patients with angina; Ethinylestradiol/etonogestrel vaginal ring and Thromboembolic risk
- Medicines Safety Update, Volume 6, Number 2, April 2015
2015 seasonal influenza vaccines; Agomelatine (Valdoxan) - monitoring of liver function; Non-steroidal anti-inflammatory drugs and diclofenac reviews
- Medicines Safety Update, Volume 6, Number 1, February 2015
Combined oral contraceptives and hormone replacement therapy - inflammatory bowel disease; Metoclopramide and neurological adverse events; Publication changes for Medicines Safety Update
- Medicines Safety Update, Volume 5, Number 6, December 2014
Epoetin alfa (Eprex) and increased risk of pure red cell aplasia with subcutaneous administration; Pregabalin and suicidality; Online reporting form for consumers; Topiramate and visual field defects
- Medicines Safety Update, Volume 5, Number 5, October 2014
Bupropion and serious cardiovascular adverse events; Methylphenidate and priapism; Propranolol - prescribing to patients who may be at risk of self-harm; Valproate - fetal exposure and cognitive impairment; Medicine shortages information resource
- Medicines Safety Update, Volume 5, Number 4, August 2014
Measles, mumps, rubella, varicella vaccine; Fentanyl patches and accidental exposure in children; Zolpidem and next day impairment; Diclofenac and arteriothrombotic events
- Medicines Safety Update, Volume 5, Number 3, June 2014
Bexsero meningococcal B vaccine - enhanced monitoring; Strontium ranelate and cardiovascular and venous thromboembolic risks; Complex regional pain syndrome and vaccines; Azathioprine and cytomegalovirus reactivation
- Medicines Safety Update, Volume 5, Number 2, April 2014
Olmesartan and sprue-like enteropathy; Codeine use in children after tonsillectomy and/or adenoidectomy; Methoxyflurane and occupational exposure
- Medicines Safety Update, Volume 5, Number 1, February 2014
Quetiapine and QT prolongation; bioCSL Fluvax - not for children under 5 years; How you can play a vital role in medicine regulation
- Medicines Safety Update, Volume 4, Number 6, December 2013
Pioglitazone risk–benefit review; 5-alpha reductase inhibitors and risk of high-grade prostate cancer; Duloxetine and serotonin syndrome; Minocycline and intracranial hypertension; What to report
- Medicines Safety Update, Volume 4, Number 5, October 2013
Atomoxetine and suicidality in children and adolescents; Rotavirus vaccination and the risk of intussusception; Drug-induced liver injury; What to report
- Medicines Safety Update, Volume 4, Number 4, August 2013
Vancomycin and nephrotoxicity, Dapagliflozin - new chemical entity, Dexmedetomidine hydrochloride and cardiovascular events, Bevacizumab and necrotising fasciitis, What to report
- Medicines Safety Update, Volume 4, Number 3, June 2013
Anticholinergics and cognitive impairment, System for Australian Recall Actions, Changes to cough and cold medicines for use in children, Update - Progressive multifocal leukoencephalopathy (PML), Mitigating risks of dabigatran: right patient, right dose and careful clinical monitoring, New dabigatran contraindication
- Medicines Safety Update, Volume 4, Number 2, April 2013
Montelukast - neuropsychiatric risks; Use of 2013 seasonal influenza vaccines in children; Denosumab and severe hypocalcaemia; Thank you for reporting
- Medicines Safety Update, Volume 4, Number 1, February 2013
Progressive multifocal leukoencephalopathy – a rare but serious disease; Thyroxine (Eutroxsig and Oroxine) and fractures; Oral bowel cleansing products – serious electrolyte disturbances
- Medicines Safety Update, Volume 3, Number 6, December 2012
Ondansetron and QTc interval prolongation - dosing change; Domperidone (Motilium) - serious ventricular arrhythmias and sudden cardiac death; Cardiovascular safety risk with fingolimod (Gilenya) - updates to the Product Information; Disposal of unwanted medicines; Changes to over-the-counter cough and cold medicines for children
- Medicines Safety Update, Volume 3, Number 5, October 2012
Post-market vigilance and introduction of the Database of Adverse Event Notifications; Lenalidomide (Revlimid) and second primary malignancy; Kogenate: home use Factor VIII and filtration
- Medicines Safety Update, Volume 3, Number 4, August 2012
Accidental paracetamol poisoning, Strontium ranelate and venous thromboembolism and serious skin reactions, Better information on medicine labels – have your say.
- Medicines Safety Update, Volume 3, Number 3, June 2012
Candesartan, fetal malformations and use in pregnancy; Zolpidem: continued reporting of abnormal sleep-related events and amnesia; Renal function assessment in prescribing Anaphylaxis with chlorhexidine-impregnated central venous catheters
- Medicines Safety Update, Volume 3, Number 2, April 2012
Change in the pregnancy category for topiramate; Use of 2012 seasonal influenza vaccines in children; Dasatinib (Sprycel) and pulmonary arterial hypertension; Pulmonary oedema associated with topical phenylephrine
- Medicines Safety Update, Volume 3, Number 1, February 2012
Pneumovax 23 - updated revaccination recommendations; Caveat emptor 'buyer beware' - the risks of purchasing unregistered medicines online; Citalopram and QT prolongation - important changes to the dosing recommendations; Atomoxetine (Strattera) - risk of increased blood pressure and/or heart rate; What to report
- Medicines Safety Update Vol 2, No 6, December 2011
Proton pump inhibitors and acute interstitial nephritis; Dabigatran (Pradaxa) and the risk of bleeding; Risk of myopathy and rhabdomyolysis with simvastatin - new dosage recommendations and contraindications
- Medicines Safety Update Vol 2, No 5, October 2011
Oral contraceptives containing drospirenone (Yaz and Yasmin) and venous thromboembolism; Pioglitazone and risk of bladder cancer; Modafinil (Modavigil) – safety update; Subscribe to TGA email alerts; What to report
- Medicines Safety Update Vol 2, No 4, August 2011
Cramps, quinine and thrombocytopenia; Venlafaxine and stress cardiomyopathy; In utero antipsychotic exposure and neonatal extrapyramidal and withdrawal adverse effects; Prescribing medicines in pregnancy – new TGA database
- Medicines Safety Update Vol 2, No 3, June 2011
Risk of hypomagnesaemia with proton pump inhibitors; Use of 2011 seasonal influenza vaccines in children; Investigation of Prevenar and deaths in children in Japan: what does it mean for Australia?; Finding information about adverse reaction reporting on the new TGA website; Medicine recalls in Australia; What to report
- Medicines Safety Update Vol 2, No 2, April 2011
Drug-induced hyponatraemia; Rotavirus vaccination and risk of intussusception: investigation of a possible safety signal; Coversyl and Coumadin: new packaging to reduce potential for dispensing errors; Suspected adverse reactions to vaccines: a reminder to report; What to report
- Medicines Safety Update Vol 2, No 1, February 2011
Clozapine and severe constipation; Drug interaction between tamoxifen and antidepressants; Methysergide and retroperitoneal fibrosis; Thank you for your reports; Suspected adverse reactions to vaccines: a reminder to report; What to report
- Medicines Safety Update No.6; 2010
Lamotrigine and serious skin reactions; Serotonin syndrome: a reminder; Drug-induced acute akathisia; Unintended pregnancy due to interaction between etonogestrel implant (Implanon) and carbamazepine; What to report
- Medicines Safety Update No.5; 2010
Cholinesterase inhibitors and syncope; Statins, macrolides and rhabdomyolysis; Uterine perforation with levonorgestrel-releasing intrauterine system; Rivaroxaban - an overview of adverse event reports; What to report
- Medicines Safety Update No.4; 2010
Varenicline (Champix): an update; Australian experience with non-adjuvant H1N1 vaccine (Panvax and Panvax Junior); New structural arrangements; What to report
- Medicines Safety Update No.3; 2010
AUST R and AUST L numbers – why are they important?; Sibutramine; Drug-induced pancreatitis and exenatide (Byetta); What to report
- Medicines Safety Update No.2; 2010
ACSOM membership announced; Safety of fish oil and omega-3 fatty acids; What to report
- Medicines Safety Update No.1; 2010
Introducing Medicines Safety Update; A new era of medicines safety monitoring and communication of benefit–risk information at the TGA; Enhanced postmarket risk management – Risk Management Plans; ACSOM – a new expert advisory medicines safety committee; Improved access to prescribing and consumer information; Hot news – experience with swine flu vaccine; The Blue Card system is not changing; What to report
Australian Adverse Drug Reactions Bulletin
1995 - 2009
The Australian Adverse Drug Reactions Bulletin was produced six times a year by the Adverse Drug Reactions Advisory Committee (ADRAC), which was replaced by the Advisory Committee on the Safety of Medicines (ACSOM) in January 2010.
The Bulletin was first published in 1982. Issues from 1995 to 2009 are available electronically.
The Bulletin was replaced by the Medicines Safety Update.
Find archived copies 1995 to 2009.
Search the Article index from 1982 to 2009