FDA Warns Hydroxychloroquine, Chloroquine Should Only Be Used By Doctors As Drugs Could Have Life-Threatening Side Effects

On Friday, the Food and Drug Administration (FDA) issued a drug safety warning for the use of hydroxychloroquine or chloroquine on COVID-19 patients outside of a hospital setting.

"Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19," the FDA said in a press release. "They are being studied in clinical trials for COVID-19, and we authorized their temporary use during the COVID-19 pandemic for treatment of the virus in hospitalized patients when clinical trials are not available."

According to the press release, when the drug is used without the proper screening and supervision from health care professionals, it can cause "serious and potentially life-threatening heart rhythm problems."

"We understand that health care professionals are looking for every possible treatment option for their patients and we want to ensure we're providing them with the appropriate information needed for them to make the best medical decisions," FDA Commissioner Stephen M. Hahn said. "While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects of these medications that should be considered. We encourage health care professionals making individual patient decisions to closely screen and monitor those patients to help mitigate these risks. The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available."

Hydroxychloroquine Sulfate Medication Illustration
In this photo illustration a pack of Hydroxychloroquine Sulfate medication is displayed on March 26, 2020 in London, United Kingdom. On Friday, April 24, the FDA issued a drug safety warning for the use of hydroxychloroquine in Covid-19 patients. John Phillips/Getty

Both hydroxychloroquine and chloroquine have been around for decades, normally used as a treatment for malaria, and other autoimmune diseases such as lupus and rheumatoid arthritis. The medications were at one time suggested by President Donald Trump as potential treatments for COVID-19 patients before the FDA approved it for the ongoing clinical trials and in emergency use. Emergency use, according to the FDA website, is allowing the use of approved and unapproved medicine to "diagnose, treat, or prevent serious or life-threatening diseases or conditions," when there are no "adequate, approved and available alternatives."

The drug safety warning by the FDA comes shortly after a team of scientists in Brazil pulled the plug on their research of the drug due to its "potential safety hazards." The study was conducted in the city of Manus and planned to test chloroquine on 440 COVID-19 patients, but the research was stopped after only 81 participants had been treated.

According to the study, one group of patients was given 600 milligrams of chloroquine twice a day for 10 days, while a second group was given 450 milligrams twice a day on the first day then once a day for four more days.

The study notes that 16 out of 41 patients in the high-dosage group died, a 39 percent fatality rate, while the low-dosage group experienced a 15 percent fatality rate, with six of the 40 patients dying.

In addition to the FDA and the Brazilian study urging caution when using these drugs to treat OVID-19 patients, the Centers for Disease Control and Prevention (CDC) and a panel of experts from the National Institutes of Health also pulled back on their support for the drugs.

As of April 24, the new coronavirus, which causes the respiratory disease COVID-19, continues to spread across the globe, infecting over 2.7 million individuals and causing at least 193,042 deaths.