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.
Trove at the National Library of Australia has copies of archived TGA material and statements.
Visit Trove to read TGA medicine safety updates from 2010 - 2017 - external site
- 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.
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:
- Read the Australian Adverse Drug Reactions Bulletin archive
- Search the Article index from 1982 to 2009