Health product safety alerts
Safety alerts and advisories from Canada and other countries all in one place.
Countries
⇡ Canada
Health Canada – Recalls and safety alerts for healthcare professionals
Health Canada – Recalls and safety alerts for the public
⇡ United States
MedWatch Safety Alerts (human medical products):
⇡ France
⇡ UK
- Addition of a polyethylene glycol (PEG)-based laxative to a liquid that has been thickened with a starch-based thickener may counteract the thickening action, placing patients with dysphagia at a greater risk of aspiration.
- A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 21 April 2021.
- A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
- Periodically perform skin examinations in patients on bendamustine-containing regimens and consider PML in the differential diagnosis for patients on bendamustine with new or worsening neurological, cognitive, or behavioural…
- A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 18 March 2021.
- A summary of letters and drug alerts recently sent to healthcare professionals.
- The indication of ulipristal acetate 5mg for uterine fibroids has been further restricted due to the risk of serious liver injury and liver failure, with some cases requiring liver transplantation. Although the temporary sus…
- Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory …
- When children receiving replacement therapy for adrenal insufficiency are being switched from hydrocortisone tablets to Alkindi granules, parents or carers should be informed of the need to be extra vigilant for symptoms of …
- Information on the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium and a new report on optimising data on medicines used during pregnancy.
⇡ Australia
- 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
- 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 – Rocuronium bromide solution for injection 10mg/mL, Hameln, and reports of lack of efficacy
- 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
- UPDATE: Concern reported with the use of NovoRapid®Penfill® (insulin aspart; 3 mL cartridge) by type 1 diabetes patients
