After President Donald Trump touted the hydroxychloroquine as a potential COVID-19 “game-changer” and the FDA issued an emergency use authorization, the drug regulator is now warning about serious side effects from treatment with the medicine.
In a new safety communication, FDA says it’s heard reports of “serious heart rhythm problems” in COVID-19 patients treated with the drug or a similar compound, chloroquine, often in combo with the antibiotic azithromycin. Hydroxychloroquine and chloroquine are decades-old medicines used to treat arthritis, lupus and malaria, but they have known heart risks, the agency says.
The FDA has been following growing use of the drugs through outpatient prescriptions, and the agency said it “strongly” recommends close medical supervision because of their known side effects. The FDA reminded doctors that its emergency use authorization—issued despite limited evidence of efficacy—only covers hospitalized patients, and only when clinical trials are not available. And azithromycin isn’t included under the emergency approval, FDA noted.
In its safety update, the agency said patients with other health issues “are likely to be at increased risk of these heart problems when receiving these medicines."
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The news comes on the heels of data showing hydroxychloroquine failed to help patients with COVID-19 in Veterans Administration hospitals. The drug—with or without azithromycin—showed "no evidence" of reducing the risk of death or of mechanical ventilation compared with supportive care, according to data posted Tuesday.
Amid the worsening COVID-19 pandemic last month, President Trump routinely praised the meds.
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A professor in France generated much of the enthusiasm with early, uncontrolled results. Later, Los Angeles Times writer Michael Hiltzik outlined flaws with that work. For instance, in one study, six patients dropped out in the first six days; those patients either died, were transferred to the ICU, couldn't tolerate the drug, or dropped for another reason. They weren't included in the final analysis, which skewed the statistics.
Meanwhile, clinical trials of the meds are ongoing as researchers continue to search for clues about how best to treat COVID-19. Researchers plan to enroll 200,000 patients to treat the meds in more than 100 studies, according to the Wall Street Journal.