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{"id":5876,"date":"2022-05-17T10:57:39","date_gmt":"2022-05-17T10:57:39","guid":{"rendered":"https:\/\/scienceandnerds.com\/2022\/05\/17\/fda-fluvoxamine-doesnt-treat-covid-19-and-heres-27-pages-why\/"},"modified":"2022-05-17T10:57:39","modified_gmt":"2022-05-17T10:57:39","slug":"fda-fluvoxamine-doesnt-treat-covid-19-and-heres-27-pages-why","status":"publish","type":"post","link":"https:\/\/scienceandnerds.com\/2022\/05\/17\/fda-fluvoxamine-doesnt-treat-covid-19-and-heres-27-pages-why\/","title":{"rendered":"FDA: fluvoxamine doesn\u2019t treat COVID-19 \u2014 and here\u2019s 27 pages why"},"content":{"rendered":"

Source: https:\/\/www.theverge.com\/2022\/5\/16\/23076314\/fda-fluvoxamine-rejection-covid-eua<\/a>
\n
<\/br><\/code><\/p>\n

\n

When the US Food and Drug Administration rejected an antidepressant as a treatment for COVID-19 on Monday, it also released a 27-page memorandum<\/a> explaining exactly why it wasn\u2019t convinced the drug was effective. It\u2019s an unusual move for the agency, which typically rejects drugs quietly without quite so much publicly available paperwork. <\/p>\n

The antidepressant fluvoxamine is a cheap, generic drug that\u2019s been used for decades. Research shows that the drug can also block inflammation in the body. So, some researchers hoped that it could help prevent severe symptoms in patients with COVID-19, some of whom have to cope with inflammation due to overactive immune systems.<\/p>\n

Some small and preliminary studies showed<\/a> that<\/a> it might be able to reduce the risk of patients with COVID-19 getting seriously sick. But that research wasn\u2019t enough to convince the FDA. The agency said in its memorandum that the studies submitted in support of the drug didn\u2019t do enough to show that it could offer \u201cclinically meaningful outcomes\u201d \u2014 reduction in hospitalizations and deaths. The main study, called the Together trial, found that the drug reduced the likelihood a patient would be in the emergency room for longer than six hours. The FDA wasn\u2019t confident that metric was important. <\/p>\n

It\u2019s uncommon to get this type of window into the FDA\u2019s decision-making process when it rejects a drug. Most of the time, the decision goes to the pharmaceutical company who made the drug, and it\u2019s kept confidential. Research shows<\/a> that those companies often don\u2019t announce rejections, and if they do, they don\u2019t say publicly the reason why. People do want to know, though: a survey of adults in the United States published in February found that nearly 90 percent said that they\u2019d want information about why a drug wasn\u2019t approved to be made public. <\/p>\n

Notably, the use of fluvoxamine as a COVID-19 treatment wasn\u2019t sent to the FDA by a pharmaceutical company \u2014 a group of doctors asked the agency to authorize it. Because it\u2019s an old and generic drug, no pharmaceutical company would profit from taking it through the expensive regulatory process. <\/p>\n

One of those doctors, the University of Minnesota infectious disease physician David Boulware, criticized the FDA\u2019s rejection, telling STAT <\/em>it was \u201cinconsistent.\u201d He noted that the coronavirus antiviral paxlovid<\/a> is more effective but that it\u2019s not widely available to people in low- and middle-income countries. \u201cIt\u2019s not my first choice as a physician but I should have the option,\u201d Boulware said.<\/p>\n<\/div>\n


<\/br><\/code><\/p>\n

Source: https:\/\/www.theverge.com\/2022\/5\/16\/23076314\/fda-fluvoxamine-rejection-covid-eua<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Source: When the US Food and Drug Administration rejected an antidepressant as a treatment for COVID-19 on Monday, it also released a 27-page memorandum explaining exactly why it wasn\u2019t convinced the drug was effective. It\u2019s an unusual move for the agency, which typically rejects drugs quietly without quite so much publicly available paperwork. 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