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27-04-2020 | Rheumatology | News | Article

Regulatory update

COVID-19: FDA warns against chloroquine, hydroxychloroquine use outside specific settings

Author:
Claire Barnard

medwireNews: The US FDA has issued a safety alert warning that chloroquine and hydroxychloroquine for COVID-19 should not be used outside of hospital settings or clinical trials due to an elevated risk for heart rhythm problems with the agents.

Chloroquine, an FDA-approved treatment for malaria, and hydroxychloroquine – approved for malaria, systemic lupus erythematosus, rheumatoid arthritis, and chronic discoid lupus erythematosus – are being studied in clinical trials for COVID-19 and have been temporarily authorized for use in hospitalized COVID-19 patients through an Emergency Use Authorization.

However, the FDA says that the drugs “have not been shown to be safe and effective for treating or preventing COVID-19,” and “we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine.”

The safety communication stresses that chloroquine and hydroxychloroquine can cause abnormal heart rhythms such as QT interval prolongation and ventricular tachycardia, and these risks may increase further when the drugs are combined with other agents known to prolong the QT interval, including azithromycin, which is also being used to treat some patients with COVID-19.

If healthcare professionals are considering using chloroquine or hydroxychloroquine for the treatment or prevention of COVID-19, the FDA recommends checking for suitable clinical trials on clinicaltrials.gov and assessing their patients’ risk for QT interval prolongation and mortality.

medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group

27 April 2020: The coronavirus pandemic is affecting all healthcare professionals across the globe. Medicine Matters’ focus, in this difficult time, is the dissemination of the latest data to support you in your research and clinical practice, based on the scientific literature. We will update the information we provide on the site, as the data are published. However, please refer to your own professional and governmental guidelines for the latest guidance in your own country.

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