The U.S. Food and Drug Administration on Friday issued a new warning against patients using the malaria drug hydroxychloroquine for COVID-19 treatment outside of a hospital setting or clinical trial, pointing to potentially fatal side effects.
FDA Commissioner Dr. Stephen Hahn said health care professionals are looking for every possible treatment option but that “known side effects” of the medication should be considered.
“We encourage health care professionals making individual patient decisions closely screen and monitor those patients to help mitigate these risks,” Dr. Hahn said. “The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available.”
The FDA has given emergency-use authorization for hydroxychloroquine and chloroquine, a similar product, to be used in hospital settings as treatment options for COVID-19 patients.
The department said that while clinical trials are underway, the medicines have not been proven safe or effective for treating COVID-19.
The FDA is investigating case reports and literature on “serious heart-related adverse events and death” in patients receiving the drugs, either alone or in combination with antibiotics.
The “adverse events” include abnormal heart rhythms, dangerously rapid heart rates, and death in some cases.
President Trump has touted hydroxychloroquine as a potential game-changer in the fight against the coronavirus. He suggested at one point that he might personally take the drug in consultation with his doctors, apparently as a preventative measure since the president has tested negative for the virus multiple times.
“Look, I’m not a doctor — study has to be done,” Mr. Trump said later on Friday. “If it helps, it’s great. If it doesn’t help, don’t do it. It does work with, as you know, malaria, lupus, et cetera and it’s a very powerful drug.”
“I would say this — if it works, I think everybody would be in favor of it,” he said.
Some people have reported positive experiences with the drug.
Democratic Michigan State Rep. Karen Whitsett credited Mr. Trump for helping fast-track the drug for limited usage.
Ms. Whitsett is now facing possible censure from Michigan Democrats after she met with Mr. Trump at the White House earlier this month with COVID-19 survivors.
Rep. Ben McAdams, Utah Democrat, said he was prescribed hydroxychloroquine during his recovery from the virus but that he wasn’t sure about the effects it might have had.
• David Sherfinski can be reached at dsherfinski@washingtontimes.com.
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