Because the SARS-CoV-2 virus was new, there were no FDA approved drugs specific to this new virus. This resulted in some health care professionals using their clinical experience to treat COVID-19 symptoms using existing FDA approved drugs off-label.
According to the FDA’s website on understanding the use of off label drugs, “once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.” The FDA’s website also states that the reason for off-label usage of a drug can stem from no approved drug exists to treat the patient’s condition, to drugs that have been approved may not be working for the patient. The U.S. Department of Health and Human Services has stated that off label drug use is very common and that one in five drug prescriptions written are for off-label use.
Hydroxychloroquine and Chloroquine
Controversy over the off-label use of hydroxychloroquine and chloroquine for COVID-19 continues today. These anti-malaria drugs received emergency use authorization from the FDA in March of 2020, based on laboratory studies that showed these medications to be effective against coronaviruses. However, the FDA revoked the EUA for hydroxychloroquine in mid-June 2020, stating that the medication was ineffective against COVID-19 and potentially harmful.
The World Health Organization (WHO) halted their hydroxychloroquine drug trials after May 2020 study reported that hydroxychloroquine was not effective against COVID-19 and was associated with heart arrhythmias and higher death rates. The validity of this study was immediately questioned and when the study data could not be obtained for independent review, study was retracted.
In June 2020, scientists affiliated with the Henry Ford Hospital System published research on hydroxychloroquine that indicated that the drug was effective in reducing the COVID-19 death rate, improved outcomes with early treatment, with no heart-related side effects were reported. These findings, however, have been criticized by health officials including Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID).
Hydroxychloroquine administered in combination with zinc and azithromycin has also been reported to be an effective treatment for hospitalized COVID-19 patients.
A January 2021 published study in the American Journal of Medicine reported that when the medicine was administered early in the treatment stage, it was effective at halting disease progression, preventing hospitalization, and reducing mortality rates. This study also reported the effectiveness of using the hydroxychloroquine in combination with either azithromycin or doxycycline, two commonly prescribed antibiotics.
Ivermectin
FDA approved to treat parasites, the drug ivermectin has been found to inhibit SARS-CoV-2, the virus that causes COVID-19, in vitro. Australian gastroenterologist Dr. Thomas Borody, known for developing the first peptic ulcer cure, reported that ivermectin administered in conjunction with zinc and the antibiotic doxycycline could be a ‘potential life-saver.’ A January 2021 published study reported that the use of ivermectin was associated with lower rates of death, especially in patients who had severe pulmonary involvement. A journal study published in April 2021 concluded that:
“Meta-analyses based on 18 randomized controlled treatment trials of ivermectin in COVID-19 have found large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance. Furthermore, results from numerous controlled prophylaxis trials report significantly reduced risks of contracting COVID-19 with the regular use of ivermectin. Finally, the many examples of ivermectin distribution campaigns leading to rapid population-wide decreases in morbidity and mortality indicate that an oral agent effective in all phases of COVID-19 has been identified.”
The FDA has not approved the use of ivermectin for SARS-CoV-2. Further, in 2021 the CDC issued a health advisory regarding the use of ivermectin as a treatment option for COVID-19 and noted it was not approved or authorized as a COVID-19 treatment and warned against its use.
Multiple studies have found ivermectin to be effective in treating COVID-19 illness, preventing hospitalization, and reducing mortality.
Budesonide
The corticosteroid Budesonide, commonly used to treat asthma symptoms, has also been successfully used off-label to treat COVID-19 symptoms. A University of Oxford study showed budesonide significantly decreased urgent care visits and hospitalizations, and shorter recovery time and duration of symptoms when used within seven days of symptom onset.
Other FDA Approved Medications
Additional medications used off-label demonstrating effectiveness in the early treatment options for COVID-19 illness include fluvoxamine, a medication typically used to treat depression, and fenofibrate, a medication used to decrease cholesterol.
