The Food and Drug Administration has issued an emergency use authorization (EUA) for two anti-malarial drugs on coronavirus patients which President Donald Trump has touted as potential game-changers. Experts have warned the drugs have only anecdotal evidence in treating COVID-19 and the drugs are not yet approved by the FDA as a treatment.
The EUA allows hydroxychloroquine sulfate and chloroquine phosphate that have been donated to the Strategic National Stockpile "to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible," according to the Department of Health and Human Services. That would mean patients who are at least 110 pounds, according to the FDA fact sheets.
Patients would also be advised to tell their doctor about any other health issues they may have such as allergies, kidney or liver disease, diabetes or pregnancy.
The drugs would be made available to patients if a clinical trial is not available to them, according to the FDA fact sheets. The patient would have the choice whether to take the drugs. The fact sheets also warn that taking the drugs as directed may not prevent more severe illness or death.
HHS issued a press release Sunday saying it has accepted 30 million doses of hydroxychloroquine sulfate from Sandoz and 1 million doses of chloroquine phosphate from Bayer to go to the Strategic National Stockpile. HHS says the drugs are available for the possible use in treating patients hospitalized with COVID-19 or for use in clinical trials.
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The EUA requires that fact sheets, including known risks and drug interactions, be made available to healthcare providers and patients, HHS said.
Both drugs can treat malaria, but hydroxychloroquine sulfate can also treat lupus and rheumatoid arthritis. The FDA tells patients in the fact sheets that neither is an approved drug for treating COVID-19, which is why they are undergoing clinical trials.
Drug trials typically require hundreds or thousands of patients and, even when accelerated, take weeks or months to complete.
Some medical professionals are expressing trepidation about rolling out these drugs without more clinical testing. In a White House coronavirus task force briefing on March 20, Dr. Anthony Fauci, the nation's top infectious disease expert, was clear in stating that any reports of hydroxychloroquine preventing COVID-19 were purely anecdotal and that more testing was needed.
“It was not done in a controlled clinical trial, so you really can't make any definitive statement about it," Fauci said.
Dr. Michelle Gong, a critical care chief at New York’s Montefiore Medical Center, told the Journal of the American Medical Association that it is imperative for doctors to do careful studies of drugs such as chloroquine to make sure they actually work, rather than just administering them to patients because they have nothing else to offer. Without that proof, “it is very easy for us to do more harm,” she said.
So far there is very little data to go on, mostly anecdotal reports from some other countries. But test tube studies in laboratories suggest the drugs may interfere with the coronavirus being able to enter cells. U.S. cardiologists have been warned by colleagues in China to be alert for side effects in heart patients.
In Arizona, an older couple experienced disastrous results when they took an additive used to clean fish tanks -- a non-medical version of chloroquine phosphate. The husband died and his wife ended up in critical condition. The wife said they took the chemical after hearing the president talk about it. She is now advising others to talk to their doctor first.
Katherine Seley-Radtke, a medical chemist for the University of Maryland, Baltimore County, writes in The Conversation that nobody should be self-medicating with these drugs until they have been approved by the FDA. She notes that issues can arise such as from interactions with other drugs, underlying health conditions and other side effects.
For most people, the coronavirus causes mild or moderate symptoms, such as fever and cough that clear up in several weeks. For some, it can cause more severe illness, including pneumonia and death.