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- InfoVigilance sur les produits de santé
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- Médicaments sécuritaires (en anglais seulement)
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- Denosumab 60mg (Prolia): should not be used in patients under 18 years due to the risk of serious hypercalcaemiaSerious 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).
- Liver monitoring requirements for cladribine in the treatment of multiple sclerosis have been introduced following uncommon cases of serious liver injury. Advise patients to seek urgent medical attention if they develop any …
- Amiodarone (Cordarone X): reminder of risks of treatment and need for patient monitoring and supervisionAmiodarone has been associated with serious and potentially life-threatening side effects, particularly of the lung, liver, and thyroid gland. We remind healthcare professionals that patients should be supervised and reviewe…
- A large study has shown no safety issues of concern relating to the use of metformin during pregnancy. The licence for metformin now reflects that it can be considered for use during pregnancy and the periconceptional phase …
- Recent information relating to COVID-19 vaccines and medicines that has been published since the February 2022 issue of Drug Safety Update, up to 11 March 2022
- 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 […]
- 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.
- 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)
- Menstrual disorders and unexpected vaginal bleeding – Comirnaty (Pfizer COVID-19 vaccine)
- Consent to distribute medicines containing bufexamac was revoked on 9 November 2021