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Medicines Safety Update

Related information

2010-present

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.

2021 2020 2019 2018 2017 2016 2015 2014 2013 2012 2011 2010

2021

  • 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.

2020

  • 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.

2019

  • 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.

2018

2017

2016

2015

2014

2013

2012

  • 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

2011

  • 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

2010

  • 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