What’s New

May 2021

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 Gabapentin (Systemic) monograph has been updated to strengthen the precautions regarding the risks of abuse and dependence, which can lead to overdose and death, especially when used concurrently with opioids or other CNS depression-producing medications. It is recommended that the risk of abuse or dependence be assessed prior to initiating gabapentin treatment and patients be regularly monitored during treatment, especially in those with current or history of abuse or dependence of opioids and/or benzodiazepines.

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

Product information with an update to safety includes Acimax, Afinitor, Aimovig, Alkeran Injection, Alkeran Tablets, Amipride, Apo-Cyproterone 100mg, Apo-Cyproterone 50mg, Apo-Ibuprofen/Codeine, Apo-Irbesartan, Apo-Lansoprazole, Apo-Telmisartan HCTZ, Baxter Potassium Chloride in Glucose Intravenous Infusion, Benadryl Original Oral Liquid, Bisolvon Chesty, Bisolvon Dry, Blincyto, Brilinta, Brufen Plus, Burinex, Coveram, Coversyl, Coversyl Plus, Covid-19 Vaccine AstraZeneca, Cyramza, DBL Aminophylline, DBL Dexamethasone Sodium Phosphate, DBL Diazepam, DBL Heparin, DBL Morphine Sulfate, DBL Sulfamethoxazole and Trimethoprim Concentrate, Enbrel, Everolimus Sandoz, Heparin (Pfizer), Hyrimoz, Idaprex, Idaprex Combi, Imbruvica, Intuniv, Kanuma, Kyleena, Lenvima, Losec, Lucrin Depot and Lucrin Depot Paediatric, Mayzent, Mekinist, Mirena, Omepral, Pradaxa, Prexum, Prexum Combi, Reaptan, Revolade, Seasonique, Solu-Medrol, Tafinlar, Trust Ibuprofen Plus Codeine, Vemlidy, Votrient, Zopral and Zopral ODT.

Product information with an update to indications includes Faslodex, Lynparza Tablets, Vimpat Injection, Vimpat Tablets and Oral Solution, Xolair, and Xtandi.


Past Content Updates
April 2021

The Pregabalin (Systemic) monograph has been updated based on a recent MHRA Drug Safety Update regarding reports of severe respiratory depression associated with pregabalin, including cases without the concurrent use of opioid medications. Cases of respiratory depression have been temporally associated with the initiation of pregabalin or dose increases. Other cases have been reported in patients with risk factors or underlying medical history. It is recommended that adjustments in dose or dosing regimen be considered in patients at increased risk of respiratory depression, including patients with compromised respiratory function, neurological or respiratory disease, renal function impairment, patients taking concurrent CNS depression-producing medications, and patients over 65 years of age.

March 2021

The Influenza Virus Vaccine (Systemic) monograph has been updated with information for the Australian 2021 influenza season. The composition of the 2021 vaccine differs from last year’s southern hemisphere vaccine with the inclusion of two new strains for the A (H1N1)-like and A (H3N2)-like viruses. In addition to egg-based influenza virus vaccines, there will also be a cell-based influenza virus vaccine available this year which is propagated in Madin Darby Canine Kidney (MDCK) cells instead of hens’ eggs.

February 2021

The Hydroxychloroquine (Systemic) monograph has been updated based on the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) findings that confirmed a link between the use of chloroquine and hydroxychloroquine and the risk of psychiatric disorders and suicidal behaviour. Psychiatric disorders, sometimes serious, have occurred in patients with or without previous mental health problems. For hydroxychloroquine, the side effects may occur in the first month following the start of treatment. It is recommended that patients contact a doctor immediately if mental health problems (e.g., anxiety, feeling confused or depressed [including thoughts of self-harm or suicide], hallucinations, or irrational thoughts) occur.

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