What’s New

December 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 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.

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

Product information with an update to safety includes Abilify Maintena; Actrapid, Mixtard, Protaphane; Advate; Aeron; Andepra; Andriol Testocaps; Androderm; APOC-5FU; Apo-Dorzolamide; Apo-Dutasteride; Apo-Imiquimod; Apo-Isotretinoin; Apomine Intermittent; Apomine Solution for Infusion; Apo-Perindopril Arginine/Amlodipine; Apo-Zolmitriptan; Atenolol Sandoz; Aubagio; Avanza SolTab; Avanza Tablets; Azarga; Bacthecal; Brintellix; Chemists’ Own Ibuprofen Double Strength; Cymbalta; DBL Ciprofloxacin; DBL Docetaxel; DBL Fluorouracil; Diflucan; Dupixent; Entecavir Apo; Fiasp; Fluad Quad; Gilenya; Hysoderm; Idhifa; Inflectra; Irbesartan/HCT Sandoz; Jurnista; Keflor CD; Lemtrada; Levemir; Mersyndol; Mersyndol DayStrength; Mersynofen; Methotrexate Injection BP (Pfizer); Movicol Junior; Movicol Lemon-Lime; Movicol Ready To Take; Myleran; Neulasta; Neupogen; Nimenrix; Noten; NovoRapid and NovoMix; Ozole 150mg; Panamax Co; Piax; Plaquenil; Pomalyst; Primaxin; Prodeine; Prodeinextra; Prolia; Ristempa; Rozlytrek; Rydapt; Ryzodeg; SciTropin A; Stieva-A; Symbicort Rapihaler; Symbicort Turbuhaler; Tacrolimus Sandoz; Tadalafil Sandoz; Tagrisso; Temizole; Teveten Plus; Tezmota; Tykerb; Ultomiris; Vaclovir; Valette; Veltassa; Vfend; Vinorelbine Ebewe; Xenical; Zoely; Zoloft; and Zytiga.

Product information with an update to indications includes Docetaxel Accord; Dovato; Erlyand; and Rimycin.


Past Content Updates
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.

September 2020

A new abbreviated monograph for remdesivir has been included this month following the provisional approval of remdesivir 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. The use of remdesivir is restricted to healthcare facilities where patients can be closely monitored.

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