Hydroxychloroquine or Chloroquine for COVID-19 – FDA Cautions for Risk of Heart Rhythm Problem

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Hydroxychloroquine and chloroquine both are FDA-approved drugs to treat or prevent malaria. Apart of anti-malarial drug hydroxychloroquine has been approved to treat autoimmune conditions also such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis.

FDA AER system database, Many case reports, published medical literatures and American Association of Poison Control centers have noticed 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. Some of the adverse events included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases, death.

Hydroxychloroquine and chloroquine:

1. It 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.

2. These drugs have not been shown to be safe and effective for treating or preventing COVID-19.

3. These 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.

4. These drugs 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.

5. These drugs can cause abnormal heart rhythms such as QT interval prolongation

6. These drugs can cause dangerously rapid heart rate called ventricular tachycardia.

7. These drugs 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.

8. These drugs 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.

For General Public

1. Patients who are taking these drugs for malaria treatment should continue their treatment and should not stop without consulting doctors. The benefit outweigh the risks at recommended dose for the approved conditions.

2. Please note that there are no proven vaccine or treatment for COVID19 till today.

3. If you are receiving hydroxychloroquine or chloroquine for COVID-19 and experience irregular heartbeats, dizziness, or fainting, seek medical attention.

For Healthcare Professionals

1. When using hydroxychloroquine or chloroquine under the EUA or in clinical trials to treat or prevent COVID-19, FDA recommends initial evaluation and monitoring .

2. Monitoring may include baseline ECG, electrolytes, renal function and hepatic tests.

3. Be alert as hydroxychloroquine or chloroquine can:

4. cause QT prolongation

5. increase the risk of QT prolongation in patients with renal insufficiency or failure

6. increase insulin levels and insulin action causing increased risk of severe hypoglycemia

7. cause hemolysis in patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency

8. interact with other medicines that cause QT prolongation even after discontinuing the medicines due to their long half-lives of approximately 30-60 days

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