The 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.
Authorization was given for 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. We 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. We are continuing to investigate these safety risks in patients with COVID-19 and will communicate publicly when more information is available.
Only Take Prescribed Chloroquine
The FDA’s Center for Veterinary Medicine has recently become aware that some consumers may mistake chloroquine phosphate used to treat disease in aquarium fish for FDA-approved drugs (used to treat malaria and certain other conditions in humans) that are being studied as a COVID-19 treatment for humans. Unfortunately, we have learned that one person in the United States has died after he and his wife reportedly took chloroquine used to treat their fish in an attempt to prevent COVID-19; his wife also became very ill.
The primary concern during the COVID-19 pandemic is the imminent threat to the health of consumers who may take animal drugs thinking they are interchangeable with approved human drugs.
Chloroquine products sold for aquarium use have not been evaluated by the FDA to determine whether they are safe, effective, properly manufactured, and adequately labeled for use in fish–let alone humans. Products marketed for veterinary use, “for research only,” or otherwise not for human consumption have not been evaluated for safety in humans.
Several Drug Trials in Progress
Drug trials continue world wide for the treatment of COVID-19. As of now (3/30/20), there are no approved medications for the specific treatment of COVID-19.
Hydroxychloroquine and Chloroquine are medications used in the treatment of Malaria and certain inflammatory conditions. Chloroquine has been used for malaria treatment and chemoprophylaxis, and hydroxychloroquine is used for treatment of rheumatoid arthritis, systemic lupus erythematosus and porphyria cutanea tarda.
Based on very limited in-vitro and anecdotal data, chloroquine or hydroxychloroquine are currently recommended for treatment of hospitalized COVID-19 patients in several countries. Both chloroquine and hydroxychloroquine have known safety profiles with the main concerns being cardiotoxicity (prolonged QT syndrome) with prolonged use in patients with liver or kidney dysfunction and immunosuppression but have been reportedly well-tolerated in COVID-19 patients.
Due to higher activity against SARS-CoV-2 and its wider availability in the United States compared with chloroquine, hydroxychloroquine has been compassionately administered to hospitalized COVID-19 patients on an uncontrolled basis in multiple countries, including in the United States.
One small study reported that hydroxychloroquine alone or in combination with azithromycin reduced detection of SARS-CoV-2 RNA in upper respiratory tract specimens compared with a non-randomized control group but did not assess clinical benefit [ Gautret P, Lagier J, Parola P, Hoang V, Meddeb L, Mailhe M, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19].
No data is available from Randomized Clinical Trials (RCTs) to provide guidelines on the use, dosing, or duration of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection(COVID19).
- Do not take any form of chloroquine unless it has been prescribed by a licensed healthcare provider and is obtained through a legitimate source.
- For more information Contact Us
Practice social distancing by sharing this information electronically.