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The Food and Drug Administration (FDA) is reporting shortages of chloroquine and hydroxychloroquine due to the increased demand for the drugs to treat hospitalized patients with coronavirus disease 2019 (COVID-19).
While neither of these agents is approved to treat the virus, recent studies have shown that the drugs could potentially reduce the duration of symptoms and viral shedding in COVID-19 patients. Chloroquine phosphate is FDA-approved for the treatment of malaria and extraintestinal amebiasis. Hydroxychloroquine sulfate is indicated for the treatment of rheumatoid arthritis, lupus erythematosus, and malaria.
Recently, the American College of Rheumatology, the American Academy of Dermatology, the Arthritis Foundation, and the Lupus Foundation of America issued a joint statement urging the government to ensure that patients with lupus and rheumatoid arthritis being treated with hydroxychloroquine have access to the medication. The statement was prompted by reports of patients across the country being unable to fill their prescriptions due to depleted supply.
Currently, several companies are reporting shortages and have provided some information on the steps being taken to resolve them to the FDA. The Agency is working closely with these companies to ensure that increased production will be done safely and quickly.
In addition, the US Department of Health and Human Services (HHS) recently accepted a donation of 30 million doses of hydroxychloroquine sulfate from Sandoz and 1 million doses of chloroquine phosphate from Bayer Pharmaceuticals. In response, the FDA issued an Emergency Use Authorization allowing for products donated to the Strategic National Stockpile to be distributed and prescribed by clinicians to hospitalized adolescent and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.
Beyond chloroquine and hydroxychloroquine, several treatments are being investigated for COVID-19, and to expedite development, the FDA has created a special emergency program called the Coronavirus Treatment Acceleration Program. “The program […] is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus,” according to the Agency.
More information related to drug shortages can be found here.
