Coronavirus FDA Q&A for Consumers

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photo FDA

The FDA is working to address the coronavirus disease (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about possible treatments and Emergency Use Authorizations (EUAs):

Q. Can disinfectant sprays or wipes be used on my skin, injected, inhaled, or ingested, to prevent or treat COVID-19?

A: No. Always follow the instructions on household cleaners. Disinfectant sprays or wipes are intended for use on hard, non-porous surfaces. Disinfectant sprays or wipes are not intended for use on humans or animals. Do not use disinfectant sprays or wipes on your skin because they may cause skin and eye irritation.

Do not inject, inhale, or ingest disinfectant sprays or household cleaners. Doing so is dangerous and may cause serious harm or death. If ingested, call poison control or a medical professional immediately.

Q: Are there data showing that chloroquine phosphate or hydroxychloroquine sulfate might benefit patients with COVID-19?

A: Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19. They are being studied in clinical trials for COVID-19, and the FDA authorized their temporary use during the COVID-19 pandemic for treatment of the virus in hospitalized patients when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (EUA) issued March 28, 2020.

In the lab, these drugs have been shown to prevent the growth of the virus that causes COVID-19. There are a few reports of patients with COVID-19 who received these drugs and improved. Some are reports of groups of patients, all of whom received the drug. It is not known whether it was the drug that led to the improvement or whether there were other factors involved. We do not know if the treated patients’ condition would have improved without the drug. To know this, there would have to be a group of similar patients who did not receive the drug (control).

Under the EUA, health care providers and patients are provided with information about the risks of these drugs. However, more data from clinical trials are necessary for us to determine whether chloroquine phosphate or hydroxychloroquine sulfate are safe and effective in treating or preventing COVID-19. In a Drug Safety Communication, the FDA cautions against the use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to the risk of heart rhythm problems.

Q: What does it mean when the FDA issues an “Emergency Use Authorization” for drugs, diagnostic tests, and/or other critical medical products?

Emergency use authorizations (EUAs) are one of several tools the FDA is using to help make important medical products available quickly during the COVID-19 pandemic. Learn more about EUAs by watching this video.

To learn more about these and other coronavirus topics, visit: Frequently Asked Questions

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