FDA Grants Emergency Use Authorization for Chloroquine

On March 27, the FDA issued an Emergency Use Authorization for chloroquine phosphate and hydroxychloroquine sulfate for treatment of COVID-19.

These drugs have been the subject of fierce debate recently, with Donald Trump proclaiming that this can be “one of the biggest game changers int he history of medicine” and critics outcrying the lack of rigorous clinical trials providing evidence for this medication.

The evidence for chloroquine is still primarily anecdotal from case series experiences. Given the immediacy and debate, the FDA provided this emergency use authorization.

Chloroquine Updates

The French group that initially published a report stating that hydroxychloroquine and azithromycin together improve recovery from COVID-19 provided an update with their experience, available here.

Gautret et al. report that in 80 patients given this drug combination, 78 improved clinically with PCR levels of virus decreasing every day. Similarly, the number of patients with a positive viral culture dropped daily. In their experience, they had 1 death, 3 transfers to the ICU, and 12 patients requiring oxygen therapy.

PCR levels of Coronavirus Decreased with Hydroxychloroquine and Azithromycin
Gautret et al. 2020.
Number of Patients with Positive Coronavirus Culture
Gautret et al. 2020.

At present, the French group treated over 1,000 patients and only had one death with hydroxychloroquine and azithromycin.

Chen et al. posted the results of their clinical trial evaluating the efficacy and safety of hydroxychloroquine. In their experience, patients who received hydroxychloroquine had a 2 day faster recovery time from cough and fever. Additionally, a significantly greater proportion of patients had improved imaging findings with hydroxychloroquine (80%) compared to control (55%). All four patients who progressed to severe illness were in the control group.

Chen et al.
Source: https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v1.full.pdf

Emergency Use Authorization

The FDA granted emergency use authorization for chloroquine and hydroxychloroquine for treatment of patients hospitalized with COVID-19 for whom a clinical trial is not available. The reasons for their recommendation are as follows:

Source: https://www.fda.gov/media/136534/download
Source: https://www.fda.gov/media/136535/download
Source: https://www.fda.gov/media/136537/download

Conclusions

This is the first therapy granted emergency use authorization from the FDA. 30 million doses of hydroxychloroquine sulfate and 1 million doses of chloroquine phosphate are added to the Strategic National Stockpile, provided by Sandoz and Bayer Pharmaceuticals.

We still need more evidence to help determine what is the optimal dosage and for how long therapy should be administered.

This authorization helps clear a lot of the hysteria about these medications, given that there has been at least one death from someone taking chloroquine phosphate used to clean fish tanks. People should not use chloroquine phosphate intended for fish, as the FDA noted. These aquarium products have not even been evaluated to see if they are safe for fish, let alone humans.

There is a lot of bickering on social media and news outlets about the efficacy of chloroquine and efficacy. I think the typical peer review publication process which takes months, requires volunteer reviewers, and still lets plenty of fake results through the pipeline is inappropriate to address our current crisis. We need something better.

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