FDA Revokes Emergency Use Authorizations for Chloroquine, Hydroxychloroquine

The FDA has announced the end of the emergency use authorizations (EUAs) for oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ), saying the potential benefits do not outweigh its known risks.¹

The original EUA was issued on March 28, 2020, in response to the coronavirus disease 2019 (COVID-19) pandemic. According to a letter from the FDA announcing the decision, the drugs no longer meet the criteria for emergency use. In order to approve an EUA, evidence must show that the drug is effective in diagnosing, treating, or preventing the disease, and that the benefits outweigh the known and potential risks.¹

“We now believe that the suggested dosing regimens for CQ and HCQ as detailed in the Fact Sheets are unlikely to produce an antiviral effect,” the FDA letter stated.¹

Despite earlier positive observations of decreased viral shedding among patients with COVID-19 who received CQ or HCQ, the letter noted that these findings have not been consistently replicated and recent data found no difference between HCQ and standard of care treatments.¹

The letter also emphasized that current treatment guidelines do not recommend the use of either drug in hospitalized patients with COVID-19 outside of clinical trials. National Institutes of Health guidelines now recommend against use of the drugs outside of clinical trial environments.¹

“Recent data from a large randomized controlled trial showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation of HCQ treatment in hospitalized patients with COVID-19,” the letter stated.¹

CQ and HCQ can both have significant adverse effects, including cardiovascular complications that can lead to heart damage and worsened cardiomyopathy. In patients who already take medications to treat preexisting cardiovascular conditions, experts have warned that HCQ, in particular, can interact with these treatments.²

The FDA did note that although HCQ distributed from the Strategic National Stockpile is no longer authorized, FDA-approved uses of HCQ can be distributed in interstate commerce. However, the CQ products covered by the EUA are not FDA-approved for any indication and cannot be legally introduced into interstate commerce.¹

REFERENCE

• FDA Letter Revoking EUA for Chloroquine, Hydroxychloroquine. June 15, 2020; https://www.fda.gov/media/138945/download. Accessed June 15, 2020.
• Hippensteele, Alana. Dangerous Cardiovascular Complications of COVID-19. Pharmacy Times; June 5, 2020. https://www.pharmacytimes.com/news/dangerous-cardiovascular-complications-of-covid-19. Accessed June 15, 2020.