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Hydroxychloroquine Emergency Use Authorization (EUA) for the treatment of COVID-19 Revoked

June 15, 2020

Hydroxychloroquine (HCQ) is a medication that has been used for many years in the treatment of malaria, rheumatoid arthritis, systemic lupus erythematosus and porphyria cutanea tarda. On March 28, 2020, the FDA issued and Emergency Use Authorization of oral formulations of hydroxychloroquine to be distributed from the Strategic National Stockpile as a potential treatment for COVID-19 in certain hospitalized patients.

Frequently Asked Questions

Can patients started on HCQ finish their treatment or do they need to stop using it now?

If a patient was started on HCQ as part of the EUA, they may finish out their therapy if desired and if found necessary by the patient’s attending physician.

Can doctors still prescribe HCQ to treat COVID-19?

Yes, doctors can still prescribe HCQ off-label for patients with COVID-19; however, the FDA has not observed benefits with therapy and there are risks of serious adverse drug events with use.

The news release release can be found on the FDA press announcement website Exit Disclaimer: You Are Leaving .

The letter to Dr. Gary Disbrow and clinical trial data Exit Disclaimer: You Are Leaving  can be found on the FDA website.

Report adverse events involving this or other medicines to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).

Instructions for reporting can be found online at the NPTC Pharmacovigilance website.