Is hydroxychloroquine approved by the Food and Drug Administration?
Yes, but for malaria, lupus and rheumatoid arthritis, not for Covid-19. For decades, doctors have been legally allowed to prescribe it for any condition they think it might help, a practice called off-label use. However, because of hoarding and high demand for hydroxychloroquine, some states like New York have ordered pharmacists to fill prescriptions only for F.D.A.-approved uses of the drug or for people participating in clinical trials.
In late March, the F.D.A. granted emergency approval to allow hospitals to use hydroxychloroquine from the national stockpile to treat patients who would not otherwise qualify for a clinical trial. Under the approval, patients and their families will receive information about the drug, and hospitals have to track information about the patients who received the drug, including their health condition and serious side effects. But that F.D.A.’s authorization for emergency use is not equivalent to meeting federal requirements, including scientific evidence through trials, that would deem hydroxychloroquine a proven treatment against the virus.
Is hydroxychloroquine being given to coronavirus patients now?
Yes. Many hospitals are giving it to patients because there is no proven treatment, and they hope it will help. Clinical trials with control groups have begun across the world. A nationwide trial began on April 2 in the United States; it is to enroll 510 patients at 44 medical centers.
Researchers say those studies are essential to find out whether the drug works against the coronavirus. If it does not, time and money can be redirected to other potential treatments.
Is there any danger in taking hydroxychloroquine?
Like every drug, it can have side effects. It is not safe for people who have abnormalities in their heart rhythms, eye problems involving the retina, or liver or kidney disease. Other possible side effects include nausea, diarrhea, mood changes and skin rashes.
The leaders of three professional societies in cardiology warned on April 8 in the journal Circulation that hydroxychloroquine and azithromycin can each cause dangerous disruptions in heart rhythm, and they wrote, “There are very limited data evaluating the safety of combination therapy.”