FDA denies generic drug fluvoxamine emergency use authorization as COVID treatment
The Food and Drug Administration
(FDA) has rejected a request to grant emergency use authorization to a cheap generic drug
for the treatment of Wuhan coronavirus (COVID-19). This decision has sparked controversy and drawn criticism from many healthcare workers.
The drug in question is fluvoxamine, an FDA-approved selective serotonin reuptake inhibitor (SSRI)
that is usually used as a treatment for mental health conditions such as obsessive-compulsive disorder and major depressive disorder.
In December 2021, Dr. David Boulware, a leading infectious diseases specialist and professor of medicine at the University of Minnesota Medical School
, submitted an emergency use authorization application for fluvoxamine to be used as an outpatient treatment for COVID-19 positive patients and to prevent the progression of their cases to hospitalization.
The FDA rejected the request
just recently, claiming that the primary randomized controlled trial conducted in Brazil did not provide sufficient evidence to prove fluvoxamine's benefits in preventing hospitalization and death. (Related: JAB 'EM YOUNG: FDA approves Pfizer's booster vaccine for children aged 5 to 11 without consulting vaccine advisory panel
"The treatment benefit of fluvoxamine was not persuasive when focusing on clinically meaningful outcomes such as proportion of patients experiencing hospitalizations or hospitalizations and death," wrote the FDA.
The Brazil trial involved nearly 1,500 participants. It met its primary endpoint, but the FDA had concerns about the fact that the "results were primarily driven by a reduction in the emergency department visits lasting greater than six hours, and there are uncertainties about the assessment of this endpoint and whether the six-hour timepoint represents a clinically meaningful threshold."
Big Pharma doesn't stand to profit from fluvoxamine's approval
In response to the FDA's rejection, Boulware wrote a letter accusing the agency of using different criteria in analyzing fluvoxamine than when it analyzed drugs submitted for review by Big Pharma companies, including paxlovid and molnupiravir – anti-COVID-19 drugs by Big Pharma companies Pfizer and Merck, respectively. Both were granted emergency use authorizations by the FDA in December 2021.
"FDA should evaluate clinical trials using the same endpoint definitions for generic drugs as for Big Pharma. The deliberate creation of two-tiered system is inappropriate," wrote Boulware.
Boulware further wrote that he believes fluvoxamine has a modest efficacy
that is comparable to that of molnupiravir and paxlovid.
"There remains a need for greater two-way communication between the FDA and the research community. FDA's current guidance for trial endpoints for outpatient early treatment of COVID-19 pretends as if it is circa 2020," wrote Boulware.
"A medication is beneficial for many reasons, including shortening duration of illness or preventing progression to severe COVID-19. Progression to hospitalization/death is substantially lower in … those with prior infection. This is no longer a realistic trial primary endpoint."
When the Epoch Times
asked the FDA for comment regarding Boulware's letter, a spokesperson for the agency wrote in an email that it "was unable to reasonably conclude that fluvoxamine may be effective for the treatment of outpatient adults with COVID-19 to prevent severe disease progression and/or hospitalization."
In an interview with Stat News
, Boulware admitted that he believes paxlovid is more effective than fluvoxamine
. However, he believes fluvoxamine still has a place in COVID-19 treatment because high-risk patients are unable to take paxlovid because it could interact with other drugs they are taking to manage COVID-19's effects.
Boulware believes fluvoxamine, as a cheap and generic drug, could also be extremely useful for low- and middle-income countries where molnupiravir and paxlovid are not yet widely available.
"It's not my first choice as a physician but I should have the option," said Boulware.
Because fluvoxamine was a cheap and generic drug and Big Pharma did not stand to profit from bringing it to the FDA for emergency use authorization, its cause was championed by Boulware and a group of other independent physicians and researchers who saw it as a cheap way to prevent COVID-19 infections from becoming severe cases.
Their efforts offered a test for how easily doctors and researchers who are not sponsored by Big Pharma could get a drug through the FDA in times of dire need.
Despite the rejection, Boulware noted that more trials on fluvoxamine's efficacy are ongoing. If more evidence comes in supporting the drug's benefits, he and other researchers may resubmit their emergency use authorization application.
has more on alternative treatments suppressed by the government.
Watch this short video of Canadian-American Dr. Peter Attia as he talks about how CVS Pharmacy helped block fluvoxamine
as a treatment for COVID-19.
This video is from the Galactic Storm channel on Brighteon.com.
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