SUMMARY:

The FDA has revoked the Emergency Use Authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate. Based on the available data, these medications do not appear to be effective in the treatment of COVID-19 and also present harms, specifically related to cardiac arrhythmias.

• An EUA is different than a full FDA approval
  • EUA based on an FDA evaluation of evidence and risks vs potential or known benefits of “unproven” products during an emergency
• Chloroquine phosphate and hydroxychloroquine sulfate, donated to the Strategic National Stockpile, received an EUA to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible
• Based on benefits/harms analysis, these medications no longer meet the EUA requirements

KEY POINTS:

• Research has demonstrated the following regarding hydroxychloroquine and chloroquine (see ‘Related ObG Entries’ below)
  • Hydroxychloroquine showed no benefit on mortality or in speeding recovery (RCT)
  • Suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19
  • “The totality of scientific evidence currently available indicate a lack of benefit”
• FDA approved use of chloroquine and hydroxychloroquine
  • Still both FDA-approved to treat or prevent malaria
  • Hydroxychloroquine is also approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis

Note: “FDA approved products may be prescribed by physicians for off-label uses if they determine it is appropriate for treating their patients, including during COVID”

Possible Drug Interaction with Remdesivir

• The FDA also released a warning regarding a potential drug interaction between remdesivir and chloroquine and hydroxychloroquine
• Data derived from a non-clinical laboratory study demonstrated possible reduction in the antiviral activity of remdesivir activity when co-administered with these medications
• The FDA is not currently aware of reduced activity in the clinical setting and continues to evaluate data on this subject

Learn More – Primary Sources:

Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine

Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use

Related ObG Topics:

RCT Results: Does Hydroxychloroquine Work for COVID-19 Postexposure Prophylaxis?

Chief Investigators of the RECOVERY Trial Report on the Hydroxychloroquine RCT

Prospective Trial Results (France): Hydroxychloroquine and Azithromycin Provide No Clinical Benefit for COVID-19

Meta-analysis of Hydroxychloroquine for the Treatment of COVID-19