FDA Warns Against Use of Chloroquine Outside of Clinical Trials


Agency says the drug is linked to cardiac dangers and shouldn’t generally be used against coronavirus

The Food and Drug Administration is warning patients and doctors that two malaria drugs touted by President Trump for use against the coronavirus are linked to cardiac dangers and should only be used in hospitalized patients or as part of clinical trials for the virus.

The two chemically similar drugs have been used for years against malaria and still may be used for that purpose.

However, the FDA said it was aware of “serious heart problems” associated with the use of the drugs, hydroxychloroquine and chloroquine, which are being evaluated in clinical studies as to whether they are useful against the coronavirus-caused disease, called Covid-19.

Specifically, the agency warned of heart-rhythm dangers, including the dangerous, too-fast heartbeat called ventricular tachycardia.

The president has regularly been urging the use of the drugs at his press briefings, at one point saying, “What do you have to lose?” and  adding, “I really think they should try it.”

In treating the coronavirus, the malarial drugs are often used in combination with the antibiotic azithromycin—a combination that could cause heart problems, a panel convened by the U.S. National Institutes of Health has warned.

Scientists including Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases have also cautioned that clinical trials are needed to determine the drugs’ effectiveness against the coronavirus.

In a recent non-peer-reviewed study, hydroxychloroquine didn’t help patients and was linked to increased deaths in research involving patients at Veterans Affairs medical centers.

The study was a so-called retrospective analysis, meaning that doctors conducting the research looked back at results in patient records. This method, while valuable, is not the sort of gold-standard research called a prospective, randomized controlled trial, in which comparable patients are randomly assigned to different treatments.

The randomization itself is a means of ensuring the patients in the treatment groups are as similar as possible.

There were a total of 368 patients in the VA analysis, of whom 97 got hydroxychloroquine, 113 got the drug plus an antibiotic and 158 didn’t get hydroxychloroquine at all. Deaths were higher in the first group, but not in the other two, researchers reported.

“We found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with Covid-19,” the researchers wrote. Their findings were posted on a medical web site prior to peer review by other doctors. They wrote that their findings highlight the need for other, prospective study “before widespread adoption of these drugs.”

Health authorities in France also recently reported serious heart problems among 54 patients taking hydroxychloroquine for coronavirus treatment. These events aren’t considered meeting the definitive gold standard for clinical studies, either.

Chinese doctors who have for months treated patients on the front lines of China’s fight against the coronavirus recently said they hadn’t seen clear evidence that drugs such as chloroquine were effective.

A trial in Brazil this month was partly suspended because patients getting high doses of chloroquine developed heart problems and appeared more likely to die.

Read full article here.

Thomas M. Burton – Wall Street Journal – April 24, 2020.

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