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TGA: New restrictions on prescribing hydroxychloroquine for COVID-19

In recent days there has been considerable focus on the potential for hydroxychloroquine and the similar compound chloroquine (which is not marketed in Australia) to help in treating COVID-19. Hydroxychloroquine is used for treatment of malaria and certain autoimmune diseases. Recent reports of increased off-label prescribing of medicines containing hydroxychloroquine have raised concerns that this will create a potential shortage of this product in Australia. Clinical trials are underway around the world examining their potential to treat COVID-19. However, these medicines pose well-known serious risks to patients including cardiac toxicity (potentially leading to sudden heart attacks), irreversible eye damage and severe depletion of blood sugar (potentially leading to coma). Given the limited evidence for effect against COVID-19, as well as the risk of significant adverse effects, the Therapeutic Goods Administration (TGA) strongly discourages the use of hydroxychloroquine outside of its current indications at this time other than in a clinical trial setting or in a controlled environment in the treatment of severely ill patients in hospital. To limit use of hydroxychloroquine to currently approved indications, there have been new restrictions placed on who can initiate therapy using it. Only certain types of specialists will be able to prescribe hydroxychloroquine to new patients (see information for health professionals below). General practitioners and other medical practitioners (e.g. hospital Resident Medical Officers (RMOS) and doctors in training) can continue to prescribe repeats for hydroxychloroquine to patients in line with the registered indications for patients in whom the medication was prescribed prior to 24 March 2020. From 24 March 2020, general practitioners and doctors in training can only prescribe these medicines for continued treatment of patients where initial treatment has been authorised by one of the specialists.

VIDEO: In this video, we look at President Donald Trump’s misleading claim that there’s “very strong evidence” to support his hope that a malaria drug can treat COVID-19, the disease caused by the novel coronavirus. Trump has touted two malaria drugs — chloroquine and its derivative hydroxychloroquine — that also are approved for use to treat lupus and rheumatoid arthritis. But there is only limited evidence at this time to suggest the drugs are safe and effective against the new coronavirus. The Guardian reports: Faced with a global coronavirus pandemic that is increasingly centered upon the US, Donald Trump has touted several drugs that he claims can help tackle the outbreak.

Chloroquine: Trump's misleading claims spark hoarding and overdoses The US president last week used a press conference to promote the use of hydroxychloroquine, a common anti-malaria drug, to treat Covid-19, saying: “I sure as hell think we ought to give it a try.”

He followed this with a tweet that claimed the use of the drug in combination with azithromycin, an antibiotic, could be “one of the biggest game changers in the history of medicine”.

Trump was immediately contradicted by public health experts including his own top infectious diseases adviser, Dr Anthony Fauci, who warned that there was only “anecdotal evidence” that the drugs could be helpful.

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Confronted with this disparity Trump, who has repeatedly made false and misleading assertions throughout the coronavirus crisis and indeed his entire presidency, responded by telling reporters that “I’m a smart guy” and “I’ve been right a lot.”


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