The Food and Drug Administration (FDA) withdrew emergency use authorizations for two coronavirus treatments on Monday. President Donald Trump promoted this drug despite concerns about their safety and effectiveness.
What We Know:
- The agency revoked the authorizations for hydroxychloroquine and chloroquine after a request from Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority.
- After reviewing new information from large clinical trials, the agency now believes that the suggested dosing regimens “are unlikely to produce an antiviral effect,” FDA chief scientist Denise Hinton said in a letter announcing the decision.
- Critics have accused the agency of caving to political pressure when it authorized use of hydroxychloroquine and chloroquine in hospitalized Covid-19 patients in late March despite thin evidence. More recent randomized controlled trials have found the drugs do not benefit coronavirus patients, and some even report it can cause heart problems.
- According to Politico, the study in question linked hydroxychloroquine to a higher risk of heart problems, but it was withdrawn after the quality of the data used was challenged. Specific reports entail doctors stating the pills, especially when paired with antibiotic azithromycin, can cause heart problems like arrhythmia.
- In April, roughly a month after the FDA authorized emergency use of the drugs, the agency warned against using hydroxychloroquine outside of hospitals and clinical trials because of potentially fatal cardiac side effects.
- Trump toned down on mentions of the pills during his White House briefings around the same time, but in May told reporters he was taking a course of hydroxychloroquine after a White House aide was diagnosed with the coronavirus.
Senate Democrats pushed FDA officials on the emergency use authorization during a Finance Committee hearing this month. Sen. Tammy Baldwin later wrote to Commissioner Stephen Hahn demanding answers on the decision and reasons why it had not been revoked even sooner.