What’s New

July 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 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 Marketing authorisation for ingenol mebutate gel in the European Union has already been withdrawn.

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

Product information with safety updates includes Acarizax, Adempas, Aimovig, Alprolix, Amisulpride Sandoz, Anzatax, Apo-Escitalopram, Apo-Fluvoxamine, Apo-Olanzapine, Apo-Prazosin, Apo-Telmisartan HCTZ, Apo-Topiramate, Apo-Zolpidem, Asmol CFC-Free Inhaler, Avil, Axit, Biktarvy, Brimica Genuair 340/12, Brufen Tablets, Captopril Sandoz, Comfarol Forte, Cosentyx, Cosopt, Cosopt Preservative Free, Curam Duo & Curam Duo Forte Tablets, Curam Duo Suspension, DBL Ergometrine, DBL Flucloxacillin Sodium, Denpax, Doxylin, Enstilar, Entyvio, Epiramax, Estalis Sequi, Estradot, Ferinject, Fluticasone + Salmeterol Cipla, Fluticasone Cipla Inhaler, Hepatitis B Immunoglobulin-VF, Loxalate, Merieux Inactivated Rabies Vaccine, Minax, Minims Tropicamide, Mirtazapine Sandoz, Mirtazapine Sandoz ODT, Ondansetron Alphapharm, Perjeta, Ponstan, ProQuad, Rh(D) Immunoglobulin-VF, Segluromet, Somidem, Stelax, Tamiflu, Tazopip, Telmisartan/HCT Sandoz, Teveten Plus, Tremfya, Varivax, Venofer, Vesanoid, Visipaque, Voxam, Xarelto, Zinforo, and Zoster Immunoglobulin-VF.

Product information with an update to indications includes Adcetris, Bavencio, Darzalex, DBL Pethidine, DuoResp Spiromax, Revestive, Stelara, Temgesic, and Venclexta.


Past Content Updates
June 2020

The Hydroxychloroquine (Systemic) monograph has been updated based on recent TGA and FDA safety communications regarding the use of hydroxychloroquine for COVID-19. At the time of publishing, the safety and efficacy of hydroxychloroquine for the treatment of COVID-19 have not been established. The use of hydroxychloroquine for the treatment of COVID-19, other than in a clinical trial setting or in a controlled environment to treat severely ill patients in hospital, is not recommended because of the limited evidence for efficacy and the risk of significant side/adverse effects. FDA is investigating reports of serious heart rhythm problems (including QT interval prolongation, ventricular fibrillation, ventricular tachycardia, and death) in patients with COVID-19 treated with hydroxychloroquine or chloroquine, either alone or in combination with azithromycin and other medications that prolong the QT interval.

May 2020

The Iron Supplements (Systemic) monograph has been updated based on a recent TGA Medicines Safety Update about the risk of symptomatic hypophosphataemia associated with ferric carboxymaltose. The risk of developing clinically significant hypophosphataemia following parenteral iron is increased in patients on long-term iron replacement, and in those with gastrointestinal disorders, lower baseline ferritin concentrations, malnutrition, or other causes of phosphate deficiency. Symptoms of hypophosphataemia may include asthenia, breathlessness, fatigue, headaches, muscular weakness and tachycardia, which may be misdiagnosed as failure to respond to treatment of iron deficiency anaemia; it is recommended that hypophosphataemia be considered as a potential cause for the continuation of these symptoms after using ferric carboxymaltose.

April 2020

The Clozapine (Systemic) monograph has been updated in light of a recent FDA drug safety communication. The FDA has strengthened an existing warning that constipation caused by clozapine can uncommonly progress to serious bowel problems, such as intestinal ischaemia, intestinal necrosis, necrotising colitis, and volvulus; fatal outcomes have been reported. The risk is increased at higher doses of clozapine or when used with other medications that cause constipation, such as anticholinergics and opioids.

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