What’s New

October 2020

NewProduct 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 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.

Remdesivir (Systemic)

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

Product information with an update to safety includes Apo-Candesartan HCTZ, Apo-Diazepam, Apo-Levetiracetam Tablets, Apo-Moxonidine, Apo-Omeprazole Tablets, Apo-Perindopril Arginine, Apo-Quinapril, Apo-Tibolone, Arazil, Aripiprazole Sandoz, Artige, Asacol, Avapro, Avapro HCT, Baraclude, Belkyra, Biktarvy, Caduet, Clopidogrel Winthrop, Clopidogrel Winthrop Plus Aspirin, Colgout, CoPlavix, Creon Micro, Daivobet Gel, Daivobet Ointment, Daktarin Oral Gel, Daunorubicin, Dithiazide, Domion, DuoCover, Duodopa, Durogesic, Enbrel, Epclusa, Erlyand, Erythrocin IV, Glypressin Solution for Injection, Glyxambi, Hizentra, Imuran Tablets and Injection, Insig, Invega, Invega Sustenna, Invega Trinza, Iscover, Jetrea RTU, Karvea, Karvezide, Ketalar, Kyprolis, Lanoxin, Lengout, Lercadip, Lercan, Lercanidipine Sandoz, Lipitor, Mesasal, Mezavant, Morphine Juno, Myozyme, Navelbine Injection, Navelbine Oral, Pantoprazole Sandoz Injection, Pantoprazole Sandoz Tablets, Plavix, Postinor-1, Prevenar 13, Prevymis, Prezcobix, Priligy, Rebif, Resotrans, Rifadin, Risperdal, Risperdal Consta, Ritalin Tablets and Ritalin LA Capsules, Sandostatin, Sandostatin LAR, Sigmaxin, Sovaldi, Stocrin, Suboxone Film, Subutex, Talam, Temgesic, Tenormin, Teriflunomide Sandoz, Timoptol-XE, Trajenta, Trajentamet, Ultiva, Valdoxan, Veletri, Vosevi, Vpriv, Zanidip, and Zepatier.

Product information with an update to indications includes Bupredermal, Kapanol, MS Contin and MS Contin Suspension, MS Mono, Norspan, Targin, Tramal, and Zaldiar.

 

Past Content Updates
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.

August 2020

The Zolpidem (Systemic) monograph has been updated based on an FDA Drug Safety Communication and recent updates to Australian Product Information documents regarding complex sleep-related behaviours. Complex sleep-related behaviours, including sleep walking, sleep driving, and engaging in other activities while not fully awake, have been reported with the use of zolpidem. It may result in serious injury or death. Complex sleep-related behaviours may occur following a single dose of zolpidem and at the recommended dose, with or without concurrent use of alcohol and other CNS depressants. The risk appears to increase with concurrent use of alcohol and other CNS depressants, or with the use of higher than recommended doses. It is recommended that zolpidem be discontinued immediately if complex sleep-related behaviours occur. Use of zolpidem is contraindicated in patients who have previously experienced complex sleep-related behaviours associated with zolpidem.

July 2020

The Ingenol mebutate (Topical) monograph has been updated based on an EMA review of ingenol mebutate gel. Following assessment of data from several studies, the EMA has concluded that ingenol mebutate gel may increase the risk of skin cancer and that the risks outweigh the benefits of treatment. Marketing authorisation for ingenol mebutate gel in the European Union has already been withdrawn.

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