US regulators on Monday revoked emergency authorization for malaria drugs promoted by President Donald Trump for treating COVID-19 amid growing evidence they don’t work and could cause deadly side effects.
The Food and Drug Administration said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus. Citing reports of heart complications, the FDA said the drugs' unproven benefits "do not outweigh the known and potential risks."
The decades-old drugs, also prescribed for lupus and rheumatoid arthritis, can cause heart rhythm problems, severely low blood pressure, and muscle or nerve damage.
The move means that shipments of the drugs obtained by the federal government will no longer be distributed to state and local health authorities for use against the coronavirus. The drugs are still available for alternate uses, so U.S. doctors could still prescribe them for COVID-19 — a practice known as off-label prescribing.
Dr. Steven Nissen, a Cleveland Clinic researcher who has been a frequent FDA adviser, agreed with the decision and said he would not have granted emergency access in the first place.
"There has never been any high-quality evidence suggesting that hydroxychloroquine is effective" for treating or preventing coronavirus infection, he said, but there is evidence of serious side effects.
On Thursday, a National Institutes of Health panel of experts revised its recommendations to specifically recommend against the drug's use except informal studies, and "that, I'm sure, had to influence on the FDA," Nissen said.
The FDA granted emergency use of the drugs for coronavirus patients in late March at the same time the U.S. government accepted 30 million doses of hydroxychloroquine and chloroquine that had been donated by two foreign drug manufacturers. Millions of those doses were shipped to U.S. hospitals to treat patients who weren't enrolled in clinical trials.
But the FDA previously warned doctors that it had seen reports of dangerous side effects and heart problems reported to poison control centers and other health systems.
As CBN News reported last month, President Donald Trump was being attacked after saying he has been taking Hydroxychloroquine and a zinc supplement daily for a week and a half as a protective treatment for coronavirus after consulting with his doctor.
"I'm taking it, Hydroxychloroquine. Right now, yeah. A couple of weeks ago I started taking it, because I think it's good, I've heard a lot of good stories," he explained.
Dr. Sean Conley, the president's doctor, issued a memorandum to the media saying he and the president discussed the treatment and decided the potential benefits outweighed any risks.
But on Fox News' Tucker Carlson program, Dr. Marc Siegel, a professor at NYU medical school, said Hydroxychloroquine is a proven anti-viral drug.
"This drug Hydroxychloroquine, which we've used in millions of people against malaria prophylaxis, so that you don't get malaria, it's used in Lupus, and other rheumatilogical problems. A top rheumatologist told me that in the lab it shows anti-viral activity against COVID-19," Seigel said.
"Henry Ford Hospital in Detroit has given it to 3,000 health care workers...to see if it prevents them from getting COVID-19, so when Dr. Sean Conley, the president's physician who I have met with and think is quite reasonable, weighs the options back and forth and decides to prescribe it for the president, it is a doctor-patient decision and it should not be challenged," he continued.
As CBN News has reported, several former COVID-19 patients, including pastors, a lawmaker, and several celebrities have said the drug proved effective in their treatment.
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