Over 100 people in the U.S. died in the first half of 2020 after taking the anti-malarial medicine hydroxychloroquine or related drugs while sick with COVID-19, according to a report.
Analysis of new data from the U.S. Food and Drug Administration’s (FDA) adverse events reporting system by the Milwaukee Journal Sentinel revealed the deaths of 293 people in the first half of this year involved hydroxychloroquine, its brand name Plaquenil, or its sister medicine chloroquine. That was up from 75 in the first half of 2019. Of those, COVID-19 was stated as the reason for the patient using the medication in “more than half” of cases, according to the newspaper.
Hydroxychloroquine has long been prescribed to prevent or treat malaria, as well as for auto-immune diseases such as lupus and rheumatoid arthritis, but has more recently been falsely promoted as a treatment for COVID-19.
In the first half of 2019, 3,251 adverse events were recorded in patients taking hydroxychloroquine or its derivatives, with over 2,441 said to be serious as the individual was hospitalized, disabled or died. In the first half of this year, 6,588 adverse events were recorded, with 6,233 designated serious.
The Milwaukee Journal Sentinel highlighted the FDA database is limited because reports and the causes of the events aren’t verified, and more than one drug may have been involved in an incident. This doesn’t mean the drugs are unsafe, but the database can be used to flag worrying signs.
Asking for comment on the findings, FDA spokesman Michael Felberbaum told the Milwaukee Journal Sentinel the agency said in April that it was aware of links between COVID-19 patients taking hydroxychloroquine or chloroquine and heart rhythm problems, including death.
Dr. Michael Carome, director of the health research group at the patient advocacy group Public Citizen and a former FDA advisory committee member, told the Milwaukee Journal Sentinel President Donald Trump’s “reckless promotion” of the drugs was partly to blame for the rise in adverse events.
President Trump has repeatedly touted the drug as a COVID-19 treatment, despite evidence to the contrary.
In March, the hype around hydroxychloroquine built after it was shown in a lab to stop the coronavirus from replicating in cells. But randomized clinical trials, which are considered the gold standard for testing if drugs work, have not found evidence the drug can either prevent people from catching the coronavirus or treat COVID-19.
According to a study published in the journal JAMA Internal Medicine, prescriptions of chloroquine and hydroxychloroquine rose in every U.S. state and Washington, D.C. between February and March.
The FDA issued but later removed an emergency-use authorization for the drugs for COVID-19, due to the risk of heart rhythm problems in these patients.
Last week, two members of the White House coronavirus task force, Dr. Anthony Fauciand Dr. Deborah Birx, said scientific evidence does not support claims that hydroxychloroquine is effective in treating COVID-19.
On Sunday, Admiral Brett Giroir, assistant secretary for Health at the Department of Health and Human Services and a medical doctor, echoed their concerns on NBC News’ Meet the Press.
“There’s no evidence to show that it is [effective against COVID-19],” he said. “Right now, hydroxychloroquine, I can’t recommend that.”