The Washington Post
FDA authorizes widespread use of unproven drugs to treat coronavirus, saying possible benefit outweighs risk
Millions of doses of the anti-malarial drugs hydroxychloroquine and chloroquine will be distributed to hospitals across the country to try to slow the disease in seriously ill patients.
The Food and Drug Administration has given emergency approval to a Trump administration plan to distribute millions of doses of anti-malarial drugs to hospitals across the country, saying it is worth the risk of trying unproven treatments to slow the progression of the disease in seriously ill coronavirus patients.
There have only been a few, very small anecdotal studies that show a possible benefit of the drugs, hydroxychloroquine and chloroquine, to relieve the acute respiratory symptoms of Covid-19 and clear the virus from infected patients.
And health experts warn the drugs’ well-known side effects could become more commonplace with much wider use. In particular, they say, patients with existing heart problems or taking certain drugs, such as anti-depressants that affect heart rhythm, are at risk of a fatal episode. Experts recommend screening before the drugs are prescribed to prevent drug-related deaths.
“The concern really is if we’re talking millions of patients, then this issue of drug-induced sudden cardiac death is absolutely going to rear its ugly head,’’ said Michael Ackerman, a pediatric cardiologist and professor at the Mayo Clinic College of Medicine and Science, who last week co-authored a key paper about the risks in response to the surge in drugs’ use.
Long-term use of the drugs also is associated with a chance of developing a form of vision loss called retinopathy, but the use of the drugs to fight virus in an infected patient is only for a few days.
The FDA’s emergency authorization does not cover longer-term use of the drugs to prevent the coronavirus infection, a practice that has become more commonplace as doctors have prescribed the drugs “off label” in response to the pandemic.
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