FDA Declines Authorization of Fluvoxamine (SSRI) for COVID-19 Treatment

Key Points:

• The U.S. Food and Drug Administration (FDA) has declined to approve the use of fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), as a treatment for COVID-19.

• Based on available evidence, the FDA deemed the drug ineffective in preventing severe COVID-19 or hospitalization among non-hospitalized patients.

• The FDA's decision leaves open the possibility of future authorization should additional research support fluvoxamine's effectiveness.

FDA's Decision:

On May 16, 2022, the FDA denied the authorization of fluvoxamine as a COVID-19 treatment. This decision was made after reviewing scientific evidence and concluding that the available data did not sufficiently support the drug's efficacy in reducing severe COVID-19 or hospitalization among non-hospitalized patients.

Research and Background:

The interest in fluvoxamine as a potential COVID-19 treatment arose from studies indicating its possible benefit in mitigating severe illness during the early stages of the virus. However, the FDA's review of available data did not yield sufficient evidence to support its effectiveness in this context.

One particular trial conducted in Brazil with approximately 1,500 participants and submitted to the FDA showed reduced hospitalization or emergency care lasting over six hours among those given fluvoxamine early on. However, the FDA raised questions regarding the strength of the observed benefit and the relevance of the six-hour threshold used to assess outcomes.

Current Status and Future Considerations:

The FDA's decision to decline authorization does not preclude the future approval of fluvoxamine for COVID-19 treatment. The FDA has indicated that further clinical trials may be necessary to more thoroughly evaluate the drug's potential effectiveness.

Implications for Individuals:

The FDA's decision highlights the importance of adhering to recommended COVID-19 prevention measures, including masking, social distancing, and vaccination, regardless of fluvoxamine use. The limited evidence supporting fluvoxamine's efficacy against COVID-19 should not be considered a substitute for established preventive and therapeutic strategies.

Individuals currently taking fluvoxamine for mental health conditions should continue their prescribed treatment as directed by their healthcare provider. However, they should not assume that fluvoxamine offers protection against COVID-19, as the evidence for such a benefit remains inconclusive.

Conclusion:

The FDA's decision to decline authorization of fluvoxamine for COVID-19 treatment reflects the need for more robust evidence to support its effectiveness. Ongoing research and clinical trials may provide additional insights into the potential role of fluvoxamine in COVID-19 management. Until then, adherence to established preventive measures and FDA-approved COVID-19 treatments remains critical in combating the impact of the virus.