’Life-threatening arrythmias’ cited by FDA

WASHINGTON — The FDA issued a warning about hydroxychloroquine’s “serious and potentially life-threatening heart rhythm problems” when used for the treatment or prevention of Covid-19.

“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, MD, said in a statement. “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.”

Previously, the FDA issued an emergency use authorization (EUA) for hydroxychloroquine to be used “in limited circumstances, such as for certain hospitalized patients with Covid-19” and said the drug could be prescribed when “a clinical trial is not available or feasible.”

But the outlook for the drug’s use as a treatment for Covid-19 is not clear. A study from Brazil suggests that high doses of the antimalaria drug chloroquine, which is chemically similar to hydroxychloroquine, caused arrythmia and death in patients. However, in the study, the drug was often combined with azithromycin and oseltamivir, so it could be the combo and not the drug alone that is causing these adverse outcomes. This and other reports, such as this study from the VA, possibly led to the FDA’s warning.

Hydroxychloroquine was enthusiastically endorsed by President Donald Trump during a press briefing on April 5, and the government stockpiled 29 million doses for compassionate use or use in trials.

Hydroxychloroquine and chloroquine are both approved for the treatment or prevention of malaria. Hydroxychloroquine is approved for use in lupus and rheumatoid arthritis. The FDA warned in its statement that neither drug has undergone clinical testing to assure is safety and efficacy against Covid-19.

Candace Hoffmann, Managing Editor, BreakingMED™

Cat ID: 190

Topic ID: 79,190,730,933,190,520,926,192,927,150,151,725,928,925,934