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FDA authorizes widespread use of unproven drugs to treat coronavirus, saying possible benefit outweighs risk
Posted by admin on 30th March 2020
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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 caused by the novel coronavirus in seriously ill patients.

There have been only a few, small anecdotal studies showing 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.

Health experts warn the drugs’ well-known side effects could become commonplace with wide 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 the 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, although doctors have been prescribed the drugs “off label” for weeks in response to the pandemic.