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
Santé Canada – Rappels et avis de sécurité pour le public
Autres ressources
- InfoVigilance sur les produits de santé
- Quoi de neuf – MedEffet Canada
- Bulletins de l’ISMP Canada
- Médicaments sécuritaires (en anglais seulement)
- Registre des médicaments et des produits de santé
- Signaler un effet secondaire
- Capsules Rx – Avis de Santé Canada (connection requise)
⇡ États-Unis
MedWatch Safety Alerts (human medical products):
⇡ France
⇡ Royaume-Uni
- Following a review of the available toxicological data and a calculation of daily exposure to boron from a typical dosing regimen, we have concluded that the balance between the benefits and risks of chloramphenicol eye drop…
- If an adverse drug reaction is suspected, ask patients if they are taking any herbal or homeopathic medicines and report any suspicions to the Yellow Card scheme. Remind patients to check that a herbal or homeopathic medicin…
- We have published guidance about the use of remote consultations for pregnancy prevention in women of childbearing potential and monitoring for signs of psychiatric reactions (especially depression) and other safety risks in…
- Revisions have been made to the information for healthcare professionals and information for UK vaccine recipients for the COVID-19 Vaccine Moderna and Pfizer/BioNTech COVID-19 vaccine following a thorough review of ext…
- A summary of letters and drug alerts recently sent to healthcare professionals.
- Cases of interstitial lung disease and pneumonitis have been reported in patients receiving CDK4/6 inhibitors indicated for some breast cancers. Ensure that patients taking these medicines are aware of the need to seek …
- Cases of severe cutaneous adverse reactions, including Stevens-Johnsons syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with immune-stimulatory anti-cancer drugs, including atezoli…
- A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 11 June 2021.
- A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
- We inform healthcare professionals of the recent campaign to promote awareness of the risk and new resources available to support safe use following previous advice to health and care professionals.
⇡ 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
