Avis de sécurité sur les produits de santé

Avis de sécurité sur les produits de santé

Avis de sécurité sur les produits de santé au Canada et d’autres pays.

Pays

* Les informations sont disponibles en anglais seulement.

Canada

Autres ressources

États-Unis


FDA – Drug Safety Podcast

MedWatch Safety Alerts (human medical products):

France

Royaume-Uni


Australie


  • Parenteral iron products and foetal bradycardia/Kounis syndrome26 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 pregnancy26 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 neutropenia26 July 2021 The Product Information for ocrelizumab has been updated to include a warning and further information about late onset neutropenia.
  • Methylphenidate – use in pregnancy22 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 syndrome2 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 […]
  • Updated contraception advice for tamoxifen23 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 colitis23 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 thromboembolism23 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 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.

Nouvelle-Zélande

  • Myocarditis and pericarditis – rare adverse reactions to Comirnaty (Pfizer COVID-19 vaccine)
  • 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 – 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

Malaisie