On Friday, the US Food and Drug Administration (FDA) issued a safety alert concerning the use of hydroxychloroquine or chloroquine for the treatment of COVID-19.
FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease. They authorized their temporary use only in hospitalized patients with COVID-19 when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (EUA). These medicines have a number of side effects, including serious heart rhythm problems that can be life-threatening.
The federal agency says they have reviewed case reports in the FDA Adverse Event Reporting System database, the 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.
An investigation into these safety risks is ongoing.
Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria. Hydroxychloroquine is also FDA-approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis.
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.
“We understand that health care professionals are looking for every possible treatment option for their patients and we want to ensure we’re providing them with the appropriate information needed for them to make the best medical decisions,” said FDA Commissioner Stephen M. Hahn, M.D. “While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects of these medications that should be considered. We encourage health care professionals making individual patient decisions closely screen and monitor those patients to help mitigate these risks. The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available.”
In addition, FDA recommends that patients taking hydroxychloroquine or chloroquine for FDA-approved indications to treat malaria or autoimmune conditions should continue taking their medicine as prescribed. The benefits of these medicines outweigh the risks at the recommended doses for these conditions.
Do not stop taking your medicine without first talking to your health care professional and talk to them if you have any questions or concerns.
Officials recommend that consumers do not buy these medicines from online pharmacies without a prescription from your health care professional. Do not take any form of hydroxychloroquine or chloroquine that has not been prescribed for you by a health care provider. Serious poisoning and death have been reported after mistaken use of a chloroquine product not intended to be taken by humans.
If you have these medicines in your home, keep them in childproof containers out of the reach of children to prevent accidental poisoning.
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