Health product safety alerts

Health product safety alerts

Safety alerts and advisories from Canada and other countries all in one place.



United States

FDA – Drug Safety Podcast

MedWatch Safety Alerts (human medical products):




  • Clonidine – importance of dosing compliance and safe storage29 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 haemolysis24 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 phosphorous27 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 events27 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 hepatotoxicity10 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 events26 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 hepatotoxicity11 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/dissection12 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 2018Infliximab and mycosis fungoides, infliximab and lupus-like syndrome, and medicine shortages mandatory reporting
  • Medicines Safety Update, Volume 9, Number 3, August-September 2018New warning labels for neuromuscular blocking agents; local anaesthetic systemic toxicity; off-label use of atropine

New Zealand

  • Myocarditis – a potential adverse reaction to Comirnaty (Pfizer COVID-19 vaccine)
  • Pregabalin and the possible risk of bullous dermatitis and exfoliating skin reactions
  • Fluad Quad – a newly funded influenza vaccine for people aged 65 years and older
  • COVID-19 vaccines and rare cases of blood clots with bleeding: no current risk with Comirnarty (Pfizer/ BioNTech) vaccine
  • UPDATE: Possible risk of psoriasis exacerbation with bupropion
  • UPDATE: Concern reported with the use of NovoRapid®Penfill® (insulin aspart; 3 mL cartridge) by type 1 diabetes patients
  • UPDATE – Yes! Cassette Pregnancy Test Kit (also known as Smiths BioMed Rapid Pregnancy Test Kit) – Reports of false positives presenting as faint lines and inconclusive results
  • Antiseptic Soothing Cream: review of the benefits and risks requested under section 36 of the Medicines Act 1981
  • UPDATE: Potential interaction between fluoxetine and levothyroxine
  • UPDATE: Important updates to clozapine data sheets and monitoring during covid-19 pandemic