France’s public health agency has issued an advisory warning against the use of hydroxychloroquine outside of clinical trials just after the country’s medicines regulator suspended clinical trials that use the drug, Politico reports.
The French High Council for Public Health now recommends that the drug not be prescribed outside of clinical trials, but French drugs regulator ANSM also announced on Tuesday that new patients should not be enrolled in clinical trials involving hydroxychloroquine, which is usually used as a treatment for lupus and to prevent malaria.
The decision to crack down on the use of hydroxychloroquine comes just days after the Lancet, one of the world’s leading medical journals, published a report that cast doubt on its effectiveness at treating the coronavirus.
“Hydroxychloroquine or chloroquine, often in combination with a second-generation macrolide, are being widely used for treatment of COVID-19, despite no conclusive evidence of their benefit,” reads the study, which was published in the Lancet last Friday. “Although generally safe when used for approved indications such as autoimmune disease or malaria, the safety and benefit of these treatment regimens are poorly evaluated in COVID-19.”
The researchers utilized data compiled from hundreds of hospitals on six continents, with patients hospitalized from late December through mid-April who all tested positive for SARS-CoV-2.
They found that Hydroxychloroquine “was associated with no evidence of benefit, but instead was associated with an increase in the risk of ventricular arrhythmias and a greater hazard for in-hospital death with COVID-19. These findings suggest that these drug regimens should not be used outside of clinical trials and urgent confirmation from randomized clinical trials is needed.”
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