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New restrictions on prescribing hydroxychloroquine for COVID-19

24 March 2020

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 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.

Information for consumers

If you are concerned that you may have symptoms of COVID-19, you should seek advice from a health professional to determine whether you need testing and how to manage your symptoms.

If you are currently taking hydroxychloroquine for a chronic condition and are worried about being able to access this medicine, please speak to your health professional.

The TGA is working with the pharmaceutical industry to help ensure supply of hydroxychloroquine is maintained for patients needing it to treat chronic conditions for which it is indicated.

Information for health professionals

There are no medicines that have been approved by the TGA for treatment of COVID-19, therefore prescribing of any medicine for the treatment of COVID-19 is considered off-label use. There is currently no clear data to inform clinical guidance on the use, dosing, or duration for COVID-19 treatment.

To help maintain the supply of hydroxychloroquine in Australia and discourage inappropriate prescribing, effective from 24 March 2020 the TGA is implementing changes to the Poisons Standard to place restrictions on the medical specialists who can initiate prescribing of the medication. Initiation of hydroxychloroquine is restricted to the following medical specialties as per the Medical Board list: dermatology; intensive care medicine; paediatrics and child health; physician; and emergency medicine.

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. General practitioners and doctors in training can prescribe these medicines for continued treatment of patients where treatment was previously initiated by one of the specialists.

Drugs and Poisons control legislation in the States and Territories will be updated as required to reflect this change to the Poisons Standard.

Safety of hydroxychloroquine and chloroquine

Hydroxychloroquine

Hydroxychloroquine is indicated for rheumatoid arthritis; mild systemic and discoid lupus erythematosus; the suppression and treatment of malaria. Hydroxychloroquine has a long half-life of >30 days.

Contraindications:

  • Children <6 years
  • Pre-existing maculopathy
  • Known hypersensitivity to hydroxychloroquine/chloroquine
  • Long-term therapy in children.

Adverse effects:

  • Cardiac toxicity including fatal cardiomyopathy
  • Severe hypoglycaemia (low blood sugar) with loss of consciousness
  • QT interval prolongation
  • Blurred vision, irreversible retinal damage
  • Skin reactions including rash/itch
  • GI disturbances including nausea/vomiting/abdominal cramps/diarrhoea
  • Muscle weakness
  • Headache
  • Alopecia
  • Blood dyscrasias, monitoring required for long-term treatment.

For further information please see the Product Information.

Chloroquine

Chloroquine is registered in the Australia Register of Therapeutic Goods but is not currently marketed. Chloroquine is indicated for the treatment of malaria.

Contraindications:

  • Retinal damage or impaired visual field
  • Allergy to chloroquine/hydroxychloroquine

Adverse effects:

  • Headache
  • Skin eruptions/itch
  • GI disturbance
  • May worsen psoriasis
  • Rare - psychotic episodes, anxiety, personality change, seizures, blood dyscrasias.

Further information

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.