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Monday, March 30, 2020
FDA Authorizes Experimental Treatments For COVID-19
he Food and Drug Administration has approved a Trump Administration plan to use unapproved and untested drugs to fight the Coronavirus pandemic. The FDA said that the possible benefits outweigh the risks of the experimental treatments.
In particular, the drugs, hydroxychloroquine and chloroquine, have been the source of optimism after a few, small, anecdotal reports hinted that they were effective in treating the COVID-19 virus. The drugs are approved treatments for malaria.
Use of the drugs is not without risks. Although both have FDA approval, they also come with known side-effects. GoodRX.com notes that hydroxychloroquine typically has fewer side-effects, but both drugs can cause irreversible vision changes, abnormal heart rhythm, muscle weakness, nerve pain, low blood glucose, and worsening of psoriasis. The side-effects are more pronounced with long-term use and at higher dosages.
The problem could be compounded by the fact that many of the critical COVID-19 patients have underlying health issues. These could include heart problems that would be compounded by the drugs’ side-effects.
Michael Ackerman, a pediatric cardiologist and professor at the Mayo Clinic College of Medicine and Science, told the Washington Post, “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.”
Despite the risks, in its authorization letter, Denise Hinton, chief scientist at the FDA, granted permission to use the drugs against COVID-19 with some restrictions because “there is no adequate, approved, and available alternative.” The authorization is valid until the FDA determines that the emergency circumstances no longer exist.
It is too early to tell whether the drugs, which have been hyped by President Trump, will be as effective against the Coronavirus as early results suggest, but the move by the FDA is nevertheless a good one. Coronavirus patients whose lives are hanging in the balance with only weeks to live deserve the chance to try.