US FDA authorizes use of chloroquine/hydroxychloroquine for emergency treatment of COVID-19 in hospitalized patients

The US Food and Drug Administration (FDA) has authorized the emergency use of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19. The authorization is limited to the chloroquine phosphate and hydroxychloroquine sulfate products supplied from the US Strategic National Stockpile to public health authorities.(1)The FDA authorization letter notes that chloroquine phosphate and hydroxychloroquine sulfate are not FDA-approved for treatment of COVID-19. However, based upon limited in-vitro and anecdotal clinical data in case series, these drugs are currently recommended for treatment of hospitalized COVID-19 patients in several countries, and a number of national guidelines have incorporated recommendations regarding use of chloroquine phosphate or hydroxychloroquine sulfate in the setting of COVID-19.(1)The FDA encourages patient participation in randomized controlled clinical trials that may produce evidence concerning the effectiveness of chloroquine and hydroxychloroquine in treating COVID-19. The FDA’s emergency use authorization is designed to facilitate the availability of chloroquine and hydroxychloroquine during the COVID-19 pandemic when a clinical trial is not available, or participation is not feasible. The drugs are intended only for the treatment of adults and adolescents who weigh ≥ 50 kg and are hospitalized with COVID-19.(1) The FDA recommends that healthcare providers visit https://clinicaltrials.gov/ to determine whether enrollment of patients in a clinical trial is more appropriate than using chloroquine/hydroxychloroquine under the emergency use authorization.(2)The FDA outlined the main reasons for authorizing the emergency use of chloroquine and hydroxychloroquine for treatment of COVID-19. First, SARS-CoV-2 can cause a serious or life-threatening disease or condition and there are no adequate, approved and available treatment alternatives. Second, the FDA concluded, based on the scientific evidence available, that it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19, and the known and potential benefits of these drugs when used to treat COVID-19 outweigh their known and potential risks.(1)Fact sheet for healthcare providers The FDA has produced a fact sheet on hydroxychloroquine sulfate for healthcare providers. It should be used in conjunction with product information contained in the approved package insert for hydroxychloroquine sulfate (for other indications). The fact sheet notes that the optimal dosage and duration of treatment for COVID-19 is unknown. However, the suggested dose for emergency use to treat adults and adolescents who weigh ≥ 50 kg hospitalized with COVID-19 is hydroxychloroquine sulfate 800 mg on the first day of treatment, followed by 400 mg daily for four to seven days of total treatment based on clinical evaluation. (The suggested dose and duration may be updated as data from clinical trials become available.)(2)A baseline electrocardiogram should be obtained to assess for QT interval prolongation and other abnormalities. Baseline evaluation of renal and hepatic function is also recommended.(2)A fact sheet for patients, parents and caregivers is also available here.(3)Adverse event/med error reporting Healthcare systems and healthcare providers will be required to perform adverse event monitoring and report all adverse events and medication errors associated with the use of these drugs to FDA by completing a MedWatch FDA Form.Record keeping Healthcare systems will also be required to maintain records regarding the dispensed authorized chloroquine and hydroxychloroquine (i.e., lot numbers, quantity, receiving site, receipt date) and maintain patient information (e.g., patient name, age, disease manifestation, other drugs administered, outcomes).Author’s commentThe purpose of this article is to inform readers of new developments. It is not intended to promote or condone off-label prescribing of drugs such as hydroxychloroquine for treatment of COVID-19. In fact, recent articles I have posted on this website (“COVID-19: Reasons to discourage off-label drug treatments” and “Hydroxychloroquine for COVID-19 prevention or treatment lacks clinical evidence”) have stressed the lack of clinical evidence for hydroxychloroquine use to prevent or treat COVID-19, the need for clinical trials to examine its efficacy, the emergence of Canadian clinical trials to evaluate efficacy, and statements by various pharmacy and medical groups that discourage off-label prescribing of hydroxychloroquine because such prescribing is causing shortages for patients taking the drug for approved therapeutic uses (e.g., rheumatoid arthritis, SLE). In addition, some reports in the media have misinterpreted the FDA emergency use authorization to mean that hydroxychloroquine has been “approved” by the FDA for COVID-19 treatment, when this is not true. The FDA letter of authorization specifies that hydroxychloroquine sulfate and chloroquine phosphate are not FDA-approved for treatment of COVID-19, but supplies from the emergency stockpile can now be requested to treat hospitalized patients who cannot be placed in clinical trials.(1) US pharmacies are also experiencing a shortage of hydroxychloroquine and off-label prescribing is being discouraged by some state pharmacy boards in the United States.(4)ReferencesHinton DM; Chief Scientist, Food and Drug Administration. Request for emergency use authorization for use of chloroquine phosphate or hydroxychloroquine sulfate supplied from the Strategic National Stockpile for treatment of 2019 coronavirus disease (letter). https://www.fda.gov/media/136534/download (accessed March 31, 2020).US Food and Drug Administration. Fact sheet for health care providers. Emergency use authorization (EUA) of hydroxychloroquine sulfate supplied from the Strategic National Stockpile for treatment of COVID-19 in certain hospitalized patients. https://www.fda.gov/media/136537/download (accessed March 31, 2020).US Food and Drug Administration. Fact sheet for patients and parents/caregivers. Emergency use authorization (EUA) of hydroxychloroquine sulfate supplied from the Strategic National Stockpile for treatment of COVID-19 in certain hospitalized patients. https://www.fda.gov/media/136538/download (accessed March 31, 2020).Bebinger M. Why hoarding of hydroxychloroquine needs to stop. Kaiser Health News March 25, 2020. https://khn.org/news/why-hoarding-of-hydroxychloroquine-needs-to-stop/ (accessed March 31, 2020).

US FDA authorizes use of chloroquine/hydroxychloroquine for emergency treatment of COVID-19 in hospitalized patients

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