Health product safety alerts
Safety alerts and advisories from Canada and other countries all in one place.
Countries
⇡ Canada
Health Canada – Find recalls, advisories and safety alerts
⇡ United States
MedWatch Safety Alerts (human medical products):
⇡ France
⇡ UK
- Maintenance doses of brolucizumab (after the first 3 doses) should not be given at intervals of less than 8 weeks apart.
- Albumin-bound paclitaxel formulations for infusion (nab-paclitaxel; brand names Abraxane, Pazenir) differ from conventional paclitaxel medicines in their authorised indications, pharmacokinetics, recommended dosages, and pre…
- Recent information relating to COVID-19 vaccines and medicines that has been published since the December 2021 issue of Drug Safety Update, up to 13 January 2022.
- A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
- We remind healthcare professionals that elderly patients are at an increased risk of adverse neurological and cardiac effects when being treated with haloperidol for delirium. The lowest possible dose of haloperidol should b…
- Fatal cases of tumour lysis syndrome (TLS) have been reported, some occurring in patients with chronic lymphocytic leukaemia receiving the lowest venetoclax dose used in the dose-titration schedule. For all patients, it is i…
- The authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus. The removal of the type 1 diabetes indication is not due to any new safety concerns and the other indications of dapaglifl…
- Recent information relating to COVID-19 vaccines and medicines that has been published since the November 2021 issue of Drug Safety Update, up to 3 December 2021.
- A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
- A standardised pre-vaccination checklist has been introduced to ensure the yellow fever vaccine is indicated for the intended travel destination and to enable vaccinators to identify existing contraindications or precautions…
⇡ Australia
- Ceftriaxone and risk of hepatitis and encephalopathy15 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 […]
- Tenofovir alafenamide and renal adverse effects6 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.
- Octreotide and atrioventricular block25 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 maculopathy11 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.
- Erenumab and hypertension9 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.
- Propylthiouracil and carbimazole – use in pregnancy15 September 2021 Health professionals are advised that the pregnancy category for both propylthiouracil and carbimazole is being changed from category C to category D.
- Minocycline and agranulocytosis30 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 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.
⇡ New Zealand
- Medsafe is issuing a warning not to use Goree Beauty Cream with Lycopene, Goree Day and Night Beauty Cream Oil Free, and Golden Pearl Beauty Cream– statement under section 98 of the Medicines Act 1981
- Reminder: Comirnaty vaccination (Pfizer COVID-19 vaccine) can cause myocarditis and pericarditis
- COVID-19 vaccination in pregnancy: no safety concerns with Comirnaty (Pfizer COVID-19 vaccine)
- Menstrual disorders and unexpected vaginal bleeding – Comirnaty (Pfizer COVID-19 vaccine)
- Consent to distribute medicines containing bufexamac was revoked on 9 November 2021
- Risks of importing or prescribing ivermectin for prevention or treatment of COVID-19
- Dihydrocodeine: review of risks and benefits
- 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
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