The FDA Just Issued a New Alert About This Popular Medication

The agency says it has not been approved for one specific use.

Whether you want to ease the pain of a building headache or need to settle a sudden upset stomach, your medicine cabinet is likely filled to the brim with different medications you can use. But while trial and error has likely helped you realize that certain medications have the ability to alleviate a number of symptoms, most are approved for very specific uses. In fact, the U.S. Food and Drug Administration (FDA) has just posted a new alert about one popular medication, warning consumers that it's not approved for one thing in particular. Read on to find out what the agency is now advising.

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The FDA is responsible for regulating medications for consumers.

man in his late fifties reaches for one of his prescription medication bottles as he sits at his dining room table
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When it comes to confirming the safety of the things you consume, the FDA leads the charge. The agency is responsible for regulating a broad scope of product categories, including both prescription and non-prescription drugs. In terms of its regulation requirements, the FDA is meant to approve medications to protect against the sale of misbranded or potentially harmful drugs, as well as supervise the recall of any medicines and warn the public about potential adverse events associated with them.

"Americans receive as many as 3 billion prescriptions for pharmaceuticals each year, and millions receive medical devices such as hip and knee implants. All medications and medical devices come with inherent risks, but it is the FDA's duty to address serious risks that can be avoided and managed," the agency explains.

Now the FDA has posted a new alert about the use of one popular medication.

The bottles of Fluvoxamine Maleate tablets on a table
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On May 16, the FDA announced that it would not be authorizing the medicine fluvoxamine as a treatment for COVID. According to the alert, a group of healthcare providers led by David R. Boulware, MD, a professor of medicine at the University of Minnesota, submitted a proposal in Dec. 2021, requesting that the agency approve this drug for the "outpatient treatment of adults 24 years and older with positive test results of SARS-CoV-2 viral testing to prevent progression to severe COVID- 19 and/or hospitalization."

The group included information from clinical trials investigating the use of fluvoxamine for COVID treatment in their proposal. But after a FDA scientific review staff assessed the available information, the agency revealed in a 27-page alert that is has chosen not to issue the requested emergency-use authorization (EUA).

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The agency says there is not enough data to authorize the medicine for use against COVID.

A woman taking an at-home COVID test on her couch
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Fluvoxamine is a generic selective serotonin reuptake inhibitor (SSRI) that is most commonly used to treat obsessive compulsive disorder (OCD), according to the Mayo Clinic. The FDA has approved the use of the medicine for OCD, as well as in the treatment of depression, anxiety, and other mood disorders. But in its new alert, the agency said that the data provided did not prove that this medicine is effective in treating infections caused by the coronavirus.

"Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatment of nonhospitalized patients with COVID-19 to prevent progression to severe disease and/or hospitalization," the FDA wrote. According to the agency, there were "uncertainties" about results from the main clinical trial cited, "design limitations" with the real-world data studies, and the treatment benefit of this medicine for severe COVID was "not persuasive."

Not everyone is happy with the FDA's decision.

Closeup of doctor's hand writing prescription
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Boulware, who led the push for the authorization of fluvoxamine in treating COVID, tweeted on May 16 that he was "disappointed" with the FDA's decision to decline his proposal. The agency has already given the green light to other COVID treatments, including Pfizer's Paxlovid pill and Merck's molnupiravir medication. But according to Boulware, there is still value in the FDA authorizing other popular medicines like fluvoxamine for the treatment of coronavirus infections.

"There are effective therapeutics that are available. But not everyone has access to them. Not everyone can tolerate them. Some people have contraindications," he told Reuters. "And if you go elsewhere in the world, low- and middle-income countries, they have access to no therapeutics."

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