FDA Issues Chloroquine/Hydroxychloroquine Safety Notice


The FDA released a drug safety communication cautioning against the use of hydroxychloroquine or chloroquine for COVID-19 outside of hospital and clinical trial settings.

The US Food and Drug Administration (FDA) released a drug safety communication cautioning against the use of hydroxychloroquine or chloroquine for coronavirus disease 2019 (COVID-19) outside of hospital and clinical trial settings. In particular, authors of the statement highlighted the risk for heart rhythm problems.

The safety communication addresses consumers, patients, infectious disease clinicians, and other health care workers in order to raise concerns of inappropriate use of these medications. The statement outlines a distinction between the widespread use of these medications and the scope of use allowed for by the FDA’s Emergency Use Authorizations for them.

“We 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. These medicines have a number of side effects, including serious heart rhythm problems that can be life-threatening,” statement authors wrote.

Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria, and for autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus, and rheumatoid arthritis. Emergency Use Authorization pertaining to COVID-19 was granted on March 28, 2020.

Concern arose after review of the FDA adverse event reporting system database, published medical literature, and data from the American Association of Poison Control Centers. Case reports detail serious heart-related adverse events and death in patients with COVID-19 who have taken hydroxychloroquine and chloroquine, alone or combined with azithromycin.

Adverse events reported include ventricular tachycardia, ventricular fibrillation, QT interval prolongation, and death. Azithromycin is also known to prolong the QT interval.

The statement authors advise that the medications should be used for COVID-19 when patients can be monitored in the hospital or through a clinical trial with appropriate screening. Outside of the hospital setting, the FDA is still reviewing safety for use in authorized patients.

Particular caution should be applied in patients who have health issues such as heart and kidney disease due to increased risk.

Patients are advised to continue taking the medications as prescribed for FDA-approved indications such as autoimmune conditions or malaria.

“The benefits of these medicines outweigh the risks at the recommended doses for these conditions,” statement authors wrote.

With respect to COVID-19, however, the authors emphasized that there are no proven treatments. Patients receiving hydroxychloroquine or chloroquine for COVID-19 who experience irregular heartbeat, fainting, or dizziness should seek medical attention.

Consumers are advised not to buy the medications from online pharmacies or another source without a prescription. No form of the products should be used if they have no ben prescribed.

Health care professionals are advised that monitoring including baseline echocardiograms, electrolyte monitoring, renal function monitoring, and hepatic tests are appropriate if patients with COVID-19 are given the medications.

Health care workers should be aware that the medications can cause QT prolongation, increase insulin levels, lead to hemolysis in patients with Glucose-6-Phosphate Dehydrogenase deficiency, and can interact with other medications even after 30 to 60 days discontinuation.

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