The malarial drug, hydroxychloroquine, was originally approved in 1949 as a treatment for malaria. More recently, it has been touted by President Donald Trump as a treatment for Covid-19 outside of a hospital setting or as part of a clinical trial.
In a warning issued by the FDA om Friday, the agency said it has become aware of “reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT-prolonging medicines.”
“Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia,” the agency wrote in the notice. “We will continue to investigate risks associated with the use of hydroxychloroquine and chloroquine for COVID-19 and communicate publicly when we have more information.”
FDA Commissioner Stephen Hahn said in a statement that the agency understands that healthcare professionals are looking for every possible treatment option for their patients and the agency wants to ensure it is providing them with the appropriate information needed for them to make the best medical decision, but the FDA also encourages healthcare professionals to “closely screen and monitor” those patients who are given those drugs.
There have been two recent studies on the use of hydroxychloroquine to treat COVID-19 patients – one sponsored by the New York Department of Health, which looked at about 600 patients at 22 hospitals in the greater New York City area.
According to the New York Post, David Holtgrave, dean of the University at Albany School of Public Health said, “We don’t see a statistically significant difference between patients who took the drugs and those who did not.” A smaller study involving 300 male patients at Veterans Health Administration medical centers across the nation also showed similar findings as the New York study.
The bottom line, reports CNBC News: The FDA has cleared some emergency use of the drugs, but the agency said Friday they “have not been approved to prevent or treat the coronavirus.”
