FDA Reverses Course

This past Monday, June 15, 2020, The Food and Drug Administration revoked an emergency approval for the use of the malaria drug hydroxychloroquine as a Covid-19 treatment stating that it is “unlikely to be effective in treating Covid-19,” warning against “serious side effects.” The withdrawal is because specific and conclusive research has shown that the drug (alone) is not effective in preventing or treating Covid-19.

In a letter to Gary Disbrow, the acting director of the Biomedical Advanced Research and Development Authority, a top FDA official said the withdrawal of the hydroxychloroquine approval was based on recent science that showed the drug to be ineffective. FDA chief scientist, Denise Hinton, explained that the “request to revoke was based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat [Covid-19] and that the drug’s potential benefits for such use do not outweigh its known and potential risks.” 

All of this comes after the FDA repeatedly expressed concerns and issued a marked warning in late April about the broad use of hydroxychloroquine outside the setting of a hospital or clinical trial.

Later in the day on Monday, the FDA also warned against using hydroxychloroquine in conjunction with Remdesivir, the Gilead Sciences drug that has shown some efficacy as a Covid-19 treatment. Co-administration of the drugs, the agency said in a statement, “is not recommended as it may result in reduced antiviral activity of Remdesivir.”

None of this, however, seems to negate its effectiveness in making zinc more absorbable by the cells. Zinc HAS been shown to help Covid-19 patients recover more quickly. So does this make hydroxychloroquine still useful as part of a larger regimen? The FDA doesn’t seem to think so.

As with every other global pandemic of the past, we are forced to sit back and wait and see how this thing plays out. Pandemics don’t seem to play fair or by the rules, and Covid-19 isn’t any different in that respect. At this point, we think it’s pretty safe to say that there aren’t going to be any miracle drugs or vaccines anytime soon.

Miracle drugs aside, we know the proper precautions to take. We know who the vulnerable and high-risk are, and how to care for them to the best of our knowledge. And we know that we will one day see the other side of this.

This, too, shall pass. 

It’s just going to take a lot longer than we want it to.  Until then, do what you can to keep yourself and those in your world safe. You know the drill.

Sources:

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and
https://www.medicalcountermeasures.gov/
https://www.drugs.com/hydroxychloroquine.html
https://www.fda.gov/media/138945/download

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