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April 24, 2020: FDA Cautions Against Use of Chloroquine or Hydroxychloroquine for COVID-19 Treatment outside of Hospital Setting or Clinical Trial

On April 24, 2020, the U.S. Food and Drug Administration (FDA) issued an announcement cautioning use of hydroxychlroquine or chloroquine outside of a hospital setting or clinical trial due to potential hazardous and fatal outcomes. The FDA had issued an Emergency Use Authorization (EUA) for temporary use of hydroxychlorquine and chloroquine in COVID-19 patients only when clinical trials were not available. These medicines have numerous side effects, including but not limited to serious heart rhythm problems that can be life-threatening.

Issues With Unsupervised Use of Chloroquine and Hydroxychlroquine

Officials at the FDA have reviewed data from the FDA Adverse Event Reporting System database, published medical literature, and the American Association of Poison Control Centers National Poison Data System concerning serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other QT prolonging medicines.  These adverse events included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases, death.  

The FDA continues to monitor and investigate these safety risks in patients with COVID-19 and will advise when more information is available.

Hydroxychloroquine and Chloroquine Information

These drugs are approved by the FDA for treatment of Malaria. Hydroxychloroquine is also approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis.

Per the FDA, hydroxychloroquine and chloroquine:

  • should be used for COVID-19 only when patients can be appropriately monitored in the hospital as required by the EUA or are enrolled in a clinical trial with appropriate screening and monitoring. FDA is reviewing the safety of their use when used outside of the setting of hospitalized patients for whom use was authorized.
  • have not been shown to be safe and effective for treating or preventing COVID-19.  
  • are being studied in clinical trials for COVID-19, and FDA authorized their temporary use during the COVID-19 pandemic under limited circumstances through the EUA, and not through regular FDA approval.  
  • being used under the EUA when supplied from the Strategic National Stockpile, the national repository of critical medical supplies to be used during public health emergencies.
  • can cause abnormal heart rhythms such as QT interval prolongation.
  • can cause dangerously rapid heart rate called ventricular tachycardia.
  • pose risks that may increase when these medicines are combined with other medicines known to prolong the QT interval, including the antibiotic azithromycin, which is also being used in some COVID-19 patients without FDA approval for this condition.  
  • should be used with caution in Patients who also have other health issues such as heart and kidney disease, who are likely to be at increased risk of these heart problems when receiving these medicines.

Further, the FDA issued the following cautions and warnings to consumers:

  • Do not buy chloroquine or hydroxychloroquine through online stores or pharmacies without a prescription from a healthcare provider.
  • Never take chroloquine or hydroxychloroquine if it has not been prescribed to you by a healthcare professional. Serious death and poisoning have been reported after mistaken use of some chloroquine products not intended for humans.
  • If these medications are in your home, keep them out of reach of children and in child-proof containers in order to prevent accidental poisoning.

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