What’s New

January 2020

New Product Summaries
Content Updates to Monographs
As part of our rigorous editorial updating process, the AusDI editorial team monitors safety information issued by the Australian Therapeutic Goods Administration (TGA), the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA), the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA). FDA-approved indications and dosing information in adults and children are also reviewed by our editorial team and included in selected monographs.

The Bupropion (Systemic) monograph has been updated based on a recent MHRA Drug Safety Update regarding the risk of serotonin syndrome. Cases of serotonin syndrome have been associated with the use of bupropion, especially in overdose or when it is used concurrently with other medications with serotonergic activity (e.g., selective serotonin reuptake inhibitors [SSRIs] and serotonin and noradrenaline reuptake inhibitors [SNRIs]). If concurrent use of bupropion with other serotonergic medications is clinically necessary, the recommended dose of bupropion should not be exceeded, and patients should monitor for symptoms of serotonin syndrome. If serotonin syndrome is suspected, a reduction in dose or discontinuation of bupropion should be considered, depending on the severity of symptoms.

New Consumer Medicine Information (CMI)
New Product Information (PI)

Product information with an update to safety includes Accuretic, Afinitor, Agomelatine Sandoz, Amisulpride Sandoz, Androcur 100, Androcur 50, Anpec, Antenex, Apo-Clopidogrel, Apo-Clopidogrel/Aspirin, Apo-Dorzolamide/Timolol, Apohealth Pantoprazole Heartburn Relief, Apo-Ivabradine, Apo-Lansoprazole, Apo-Rabeprazole, Apo-Risedronate, Apo-Temozolomide, Apo-Venlafaxine XR, Arimidex, Asacol, Azep, Bosentan Apo, Bridion, Brufen Plus, Bupivacaine Injection (Pfizer), Bydureon, Cablivi, Cabometyx, Cardol 160mg, Cardol 80mg, Chemists’ Own Sinus + Allergy & Pain Relief, Cipramil, Contrave, Cordilox SR, Cyprostat 100mg, Cyprostat 50mg, DBL Cefotaxime, DBL Naloxone Hydrochloride, DBL Vincristine, Denpax, Dolased, Dormizol, Esipram, Imuran Tablets and Injection, Invanz, Isoptin Injection, Isoptin Tablets, Kanjinti, Luvox, Lyrica, Modafinil Sandoz, Movox, Mydol 15, Neupro, Nicorette Chewing Gum, Nicorette Invisipatch, Oncaspar Powder for Injection, Quinbisul, Repatha, Rexulti, Rixadone Tablet, Solian, Somatuline Autogel, Stilnox. Stilnox CR, Tecentriq, Temaze, Tensig, Teriflunomide Sandoz, Tysabri, Viatocinon, Vincristine (Pfizer), and Voriconazole Sandoz.

Product information with an update to indications includes Forxiga, Imbruvica, Imfinzi, Momex SR, Morphine MR Apotex, Stelara, Tramadol Sandoz Injection, and Tramadol Sandoz SR.


Past Content Updates
December 2020

The Insulin and Insulin Analogues (Systemic) monograph has been updated based on a recent MHRA Drug Safety Update regarding the risk of cutaneous amyloidosis at the injection site with all types of insulins. Injection of insulin can lead to cutaneous amyloidosis at the injection site, especially if the site is used regularly. Cutaneous amyloidosis interferes with insulin absorption and may affect glycaemic control if insulin is administered at the site. Patients should be advised to rotate injection sites within the same body region to reduce or prevent the risk of cutaneous amyloidosis and other skin reactions. Patients who are currently injecting insulin into an area with cutaneous amyloidosis should contact their doctor before changing injection sites because a sudden change may result in hypoglycaemia.

November 2020

The FDA has recently issued a Drug Safety Communication warning that taking higher than recommended doses of diphenhydramine can lead to serious heart problems, seizures, coma, or death. It is investigating reports of teenagers being admitted to emergency departments or dying after misuse of diphenhydramine encouraged by the “Benadryl Challenge” promoted on social media.

The Antihistamines (Systemic) monograph contains information about antihistamine overdose.

October 2020

The Thiazide Diuretics (Systemic) monograph has been updated to include the side effect choroidal effusion based on an update to the Dithiazide Product Information and the EMA’s Pharmacovigilance Risk Assessment Committee recommendations. There have been cases of choroidal effusion with visual field defect reported following the use of thiazide and thiazide-like diuretics, such as chlortalidone and hydrochlorothiazide. There has also been a recent TGA safety advisory for hydrochlorothiazide regarding the increased risk of non-melanoma skin cancer. Epidemiological studies have found an increased risk of non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma) associated with the use of hydrochlorothiazide, which is thought to be caused by the photosensitising activity of hydrochlorothiazide.

The full monograph for remdesivir is now available. Remdesivir has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in adults and adolescents (12 years of age and older and weighing at least 40 kg) with pneumonia, requiring supplemental oxygen.

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