The Drug Safety Communication published Friday said the agency cautions against the use of hydroxychloroquine or chloroquine for COVID-19 treatment outside of hospitals or clinical trials due to the risk of heart rhythm problems.

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The Food and Drug Administration is warning against the use of two drugs President Donald Trump has repeatedly touted as a possible "game changer" in the fight against the coronavirus.


The Drug Safety Communication published Friday said the agency cautions against the use of hydroxychloroquine or chloroquine for COVID-19 treatment outside of hospitals or clinical trials due to the risk of heart rhythm problems.


"Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19," the FDA warned. Both can cause abnormal heart rhythms and a dangerously rapid heart rate, the statement said.


The FDA explicitly warned consumers not buy the drugs from online pharmacies without a prescription from a health care professional. "Consumers should not take any form of chloroquine that has not been prescribed for them by a healthcare professional," the agency stated on its website.


The FDA communication may bring an end to confusing and unsubstantiated claims about the two drugs. They began with tiny anecdotal studies in China, were amplified by an eccentric French microbiologist who likes to tweak the establishment and made their way to the White House where the president repeatedly suggested the drugs might help, saying, "What have you got to lose?"


"This is an important and timely statement from the FDA," said Rajesh Gandhi, an infectious diseases physician at Massachusetts General Hospital and professor at Harvard Medical School.


"It reminds clinicians and the public that there are no proven or FDA approved treatments for COVID-19, and highlights the potential side effects of hydroxychloroquine and chloroquine, including serious and life-threatening heart rhythm problems."


Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria. Hydroxychloroquine is also FDA-approved to treat autoimmune conditions such as lupus and rheumatoid arthritis.


Doctors, including director of the National Institute of Allergy and Infectious Diseases Anthony Fauci, have cautioned for months that without well-run clinical trials it is impossible to know if either drug is effective – or safe – to treat COVID-19, the disease caused by the new coronavirus.


While multiple clinical trials testing the drugs' efficacy and safety in COVID-19 patients are underway, early results indicatethe answer is no.


A study posted on April 21 involving 368 patients with confirmed cases of COVID-19 treated at Veterans Health Administration medical centers found there were more deaths among those given hydroxychloroquine than those receiving standard care. In addition, the drug made no difference in the need for a breathing machine.


"These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs," the study authors said.


A Brazilian double-blind research study published last week found chloroquine to be so dangerous at high doses the trial was shut down after six days.


The study found one-quarter of the patients taking the anti-malaria medication developed potentially deadly changes in the electrical system regulating their heartbeats. While a small and imperfect study, it highlighted the compelling need for more rigorous data.


Both drugs have had had a rocky history in the months since the COVID-19 pandemic began to sweep the globe.


There were small, anecdotal, non-peer reviewed reports about the drugs in China as early in February. None wereup to the scientific gold standard of a double-blind, randomized, placebo-controlled trial that would definitively show they worked or not.


Interest in them took off when a controversial microbiologist in France posted a video on Feb. 25 promoting the use of hydroxychloroquine to treat COVID-19. Didier Raoult, has denied climate change is happening and wrote a book declaring Darwin's theory of evolution was wrong.


He then posted two small studies of the drugs on COVID-19 patients that were quickly criticized by scientists because they had no control group, making it impossible to know if people who got the drugs recovered any faster than those who didn't.


Television doctor Mehmet Oz initially supported the drug multiple times on Fox and Friends but this week began backing away from it.


Trump first spoke about hydroxychloroquine given together with the antibiotic azithromycin on March 19. He went on to tout them numerous times in various media and public events.


On April 13 he announced his administration had deployed roughly 28 million doses of hydroxychloroquine from the National Stockpile. "Just recently, a friend of mine told me he got better because of the use of that, that drug," he said in a briefing.


Trump has since toned down his support of the drugs. On Thursday he floated the idea of using "light inside the body" and studying the use of disinfectants "by injection." His comments triggered an urgent warning from the maker of Lysol that "under no circumstances" should its product be used as treatment.


The FDA's statement Friday is only the latest in the scientific community urging the need for more study of two drugs that are known to cause significant side effects.


"It may also be worth noting that there are over 40 side effects associated with hydroxychloroquine dosage. These include dry cough, hoarseness, fever, difficulty breathing and increased incidence of cardiac arrhythmia," said John Scott, chair of the department of pharmacology at the University of Washington School of Medicine.


The U.S. Centers for Disease Control and Prevention abruptly switched its guidance for use of hydroxychloroquine on April 7, dropping its reference to anecdotal dosages to say simply that there are no approved drugs for dealing with the disease.


The CDC's online advice for hydroxychloroquine was updated three days after Reuters reported the CDC was offering what the news agency called "highly unusual guidance" for the drug's use based on "unattributed anecdotes rather than peer-reviewed science."


On April 11 the Infectious Diseases Society of America guidelines panel recommended patients hospitalized with COVID-19 be given chloroquine or hydroxychloroquine in the context of a clinical trial.


On April 11 the Infectious Diseases Society of America guidelines panel recommended patients hospitalized with COVID-19 be given chloroquine or hydroxychloroquine in the context of a clinical trial.


The FDA statement will be helpful to doctors, said Daniel Kaul, a professor of infectious disease at the University of Michigan medical school.


"This kind of taking a step back is taking the politics out of it, letting clinical trials move forward so we can figure out if there is any effect, what the safety profile is, in what situation might the drugs be helpful or harmful," he said.


In a clinical trial, patients are very carefully taken through an informed consent process where they're given information about all the potential risks and benefits, known side effects and other issues.


That context is "a much more comfortable place for us as doctors," Kaul said. "It will be helpful in communicating with patients and their families, who are desperate for a treatment. We can say 'The FDA is concerned and says these drugs should only be given in clinical trials.'"