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
⇡ France
⇡ UK
- Decreased vitamin B12 levels, or vitamin B12 deficiency, is now considered to be a common side effect in patients on metformin treatment, especially in those receiving a higher dose or longer treatment duration and in those …
- We have issued a National Patient Safety Alert following serious reports of harm associated with insulin leakage during use of the Accu-Chek Insight Insulin pump with NovoRapid PumpCart prefilled insulin cartridges. Patients…
- Recent information relating to COVID-19 vaccines and medicines that has been published since the May 2022 issue of Drug Safety Update, up to 17 June 2022.
- A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices
- Serious and life-threatening hypercalcaemia has been reported with denosumab 60mg (Prolia) in children and adolescents in clinical trials for osteogenesis imperfecta and during off-label use. Denosumab 60mg (Prolia) is autho…
- Recent information relating to COVID-19 vaccines and medicines that has been published since the April 2022 issue of Drug Safety Update, up to 13 May 2022.
- A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. Includes a recent recall of Accupro (quinapril hydrochloride) and advice on Xagrid (anagrelide hydrochloride…
- A new study has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Patients should continue to use effective contraception during treatment and avoid use in pregnancy …
- Recent information relating to COVID-19 vaccines and medicines that has been published since the March 2022 issue of Drug Safety Update, up to 14 April 2022.
- A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. Includes a recent recall of Accuretic (quinapril hydrochloride and hydrochlorothiazide).
⇡ Australia
- Product Information safety updates – June 202210 June 2022 The TGA has identified new safety information for medicines. The TGA has worked closely with sponsors of the medicine to update the Product Information (PI) to ensure consumers and health professionals are informed.
- Product Information safety updates – April 202222 April 2022 The TGA has identified new safety information for medicines. The TGA has worked closely with sponsors of the medicine to update the Product Information (PI) to ensure consumers and health professionals are informed.
- Clozapine and gastrointestinal hypomotility with severe complications22 April 2022 The potentially fatal risk of gastrointestinal hypomotility in patients taking clozapine has been highlighted with a new boxed warning in the Product Information (PI) for this medicine.
- Donepezil and cardiac conduction disorders28 February 2022 Cardiac conduction disorders have been reported in patients receiving donepezil. The Product Information (PI) documents for this medicine are being updated to advise caution in patients with known QTc prolongation or a family history of this condition.
- Administer vinca alkaloids by intravenous infusion only24 February 2022 Unintended intrathecal injection of vinca alkaloids can result in fatal outcomes. To prevent this, the Product Information (PI) for vincristine, vinblastine and vinorelbine products has been changed to ensure these medicines are always given intravenously and by no other route.
- Ipilimumab and serous retinal detachment18 February 2022 Treatment with ipilimumab has been linked to the rare yet serious adverse event of serous retinal detachment. The amount of photoreceptor degeneration and loss of vision can be minimised by early diagnosis and treatment.
- SGLT2 inhibitors approved for T2DM only15 February 2022 Sodium glucose co-transporter 2 inhibitor products are approved for use in the management of type 2 diabetes mellitus – they are not approved for use in type 1 diabetes. Prescribers are reminded of the risk of diabetic ketoacidosis with the off-label use of these medicines.
- Clindamycin capsules and injections – acute kidney injury3 February 2022 A new warning about the nephrotoxic potential of clindamycin capsules and injections has been added to the Australian Product Information (PI). This is not a previously known adverse event associated with this medicine. Health professionals should consider monitoring renal function for certain patients.
- Antidepressant use and youth suicide20 January 2022 The TGA has continued its safety investigation of antidepressant use and the risk of suicide in young people. A recent NPS MedicineWise MedicineInsight analysis investigating antidepressant utilisation in young people attending general practice has been completed.
- 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 […]
⇡ New Zealand
- Accuretic found to contain nitrosamines
- Typographical error in Healgen Rapid COVID-19 Antigen Self-Test (RATs) patient instruction leaflet
- Reminder: Miracle Mineral Solution has dangerous and potentially life-threatening side effects
- Possible risk of vasculitis with vildagliptin products (Galvus, Galvumet)
- Buccaline tablets: review of the benefits and risks under section 36 of the Medicines Act 1981
- Update – Pregabalin and the possible risk of bullous dermatitis and exfoliating skin reactions
- Update – Dihydrocodeine: review of risks and benefits
- 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)
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