EMA: Chloroquine only to Be Used in Clinical Trials or Emergency Use Programmes

03 April 2020

GMP News

Chloroquine and hydroxychloroquine, two medicines currently authorised for malaria and certain autoimmune diseases, are being investigated worldwide for their potential to treat coronavirus disease (COVID-19). However, efficacy in treating COVID-19 is yet to be shown in studies.

Both chloroquine and hydroxychloroquine can have serious side effects, especially at high doses or when combined with other medicines. They must not be used without a prescription and without supervision by a doctor; prescriptions should not be given outside their authorised uses except in the setting of a clinical trial or nationally agreed protocols.

Considering the urgency and the pressure healthcare systems face to save lives during the COVID-19 pandemic, some countries, including the USA and France, have put strict protocols in place to allow the experimental use of these two medicines, for example, in patients with severe forms of COVID-19.

Chloroquine and hydroxychloroquine are vital medicines for patients with autoimmune conditions such as lupus. It is important that such patients are still able to obtain them and do not face shortages caused by stockpiling or use outside the authorised indications. In some countries, prescribing of the medicines has been restricted to reduce the risk of shortages.

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