The US has granted initial approval to distribute a controversial drug to fight the outbreak of COVID-19.
The FDA, also known as the Food and Drug Administration, has approved Chloroquine Phosphate or Hydroxychloroquine Sulfate to be distributed from the country’s national stockpile.
FDA chief scientist Denise Hinton wrote in her approval, it’s “reasonable to believe” the drug might be effective in fighting coronavirus.
The department noted the drug will only be available to people who weigh 50kg or more and have COVID-19.
According to the Centers for Disease Control and Prevention, the US currently has more than 160,000 confirmed cases of the virus and more than 3,000 deaths.
Despite concerns from the medical community, US President Donald Trump has touted the use of the medication as “one of the biggest game changers in the history of medicine” and should “be put in use immediately”.
Chloroquine has been used to treat malaria since the 1930s. Hydroxychloroquine came along a decade later and has fewer side effects. The latter is sold in generic form and under the brand name Plaquenil for use against several diseases.
However, the drugs can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage. Plaquenil’s label warns of possible damage to the retina, especially when used at higher doses, for longer times and with certain other medicines such as the breast cancer drug tamoxifen.
Doctors have also raised concerns about pushing the drug into hospitals.
Michael Ackerman, a pediatric cardiologist and professor at the Mayo Clinic College of Medicine and Science told The Washington Post, if the drug is used to treat millions “then this issue of drug-induced sudden cardiac death is absolutely going to rear its ugly head”.
Some French doctors and politicians are also pushing to expand hydroxychloroquine’s use. The mayor of the French city of Nice, Christian Estrosi, said on television Monday, local time, that he was on his sixth day of treatment and has “the sense I’ve been cured.”
Scientists, however, warn about raising false hopes and say major studies are needed to prove the drugs are safe and effective against coronavirus, and to show that people would not have recovered just as well on their own. One such study starts Tuesday (local time) in New York.
Former Food and Drug Administration commissioner Dr Scott Gottlieb told CBS at the moment “there is no drug” that even looks like “it’s proven so overwhelming in early-stage clinical trials that we can say it’s highly promising”.
Some people are even trying to take matters into their own hands, with disastrous consequences. A Phoenix-area man died and his wife remains in critical condition after taking chloroquine phosphate, an additive used to clean fish tanks. The cleaning agent has the same active ingredient as the medicine chloroquine but is formulated differently.
Dr Daniel Brooks of Banner Health Care’s poison centre in Phoenix urged people not to self-medicate.
“The last thing that we want right now is to inundate our emergency departments with patients who believe they found a vague and risky solution,” he said.
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