Hydroxychloroquine Production Surges for COVID-19

March 31, 2020

The rheumatology community has expressed concerns about the use of hydroxychloroquine sulfate for COVID-19 because the drug is used to treat lupus patients and is already in short supply. The FDA has taken steps to redistribute the drug to hospitals for COVID-19 patients despite the lack of extensive clinical trials testing.

On Saturday, the U.S. Food and Drug Administration issued an Emergency Use Authorization to allow hydroxychloroquine sulfate and chloroquine phosphate products to be donated to the Strategic National Stockpile (SNS) for the purpose of distributing the drug to hospitals treating COVID-19 patients.

The decision was made despite the recommendations from healthcare experts who questioned the validity of the science behind the recommendation. The rheumatology community has expressed concerns about the use of hydroxychloroquine sulfate for COVID-19 because the drug is used by patients with systemic lupus erythematosus to control flares and is already in short supply.

The American College of Rheumatology (ACR) has issued talking points for physicians who treat lupus patients with hydroxychloroquine. Many patients, they report, have been unable to fill prescriptions, but companies that produce hydroxychloroquine are ramping up production.

Amneal Pharmaceuticals told Barron's that they will produce 20 million pills by mid April. Mylan said it could provide 50 million pills. Teva Pharmaceuticals Industries was planning to ship six million pills by the close of March and the Novartis subsidiary, Sandoz, shipped 30 million tablets to the U.S. Department of Health and Human Services for COVID-19 clinical trials. Sandoz also donated 130 million tablets globally to combat the pandemic.

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Prior to the COVID-19 outbreak, an average of 8.5 million hydroxychloroquine tablets were produced weekly, Barrons reported.

In rheumatology, hydroxychloroquine (Plaquenil), is a disease-modifying anti-rheumatic drug (DMARD) that decreases muscle and joint pain, and reduces skin rashes, pericarditis, pleuritis and other symptoms associated with systemic lupus. According to Johns Hopkins Medicine, the treatment is associated with extending the life expectancies of these patients. While other antimalarials can be in lupus (chloroquine (Aralen) and quinacrine (Atabrine)), hydroxychloroquine is the preferred treatment because it is associated with fewer adverse events. Quinacrine, though, is only available from a compounding pharmacist.

The ACR recommends that physicians work closely with their patients to determine how best to proceed with treatment in the absence of hydroxychloroquine. "Many rheumatology patients are able to reduce their dose of hydroxychloroquine, or even go off the drug completely, for some time without suffering a flare," according to a statement issued by the ACR.