FDA urges close monitoring of COVID-19 patients treated with hydroxychloroquine
pharmafile | April 27, 2020 | News story | Sales and Marketing | COVID-19, FDA, chloroquine, coronavirus, hydroxychloroquine
The FDA has released a safety communication reiterating the need for doctors to closely monitor COVID-19 patients who are treated with either hydroxychloroquine or chloroquine.
This is due to severe side effects that have become apparent in multiple clinical trials in testing how effective the drug is in treating the coronavirus.
In a statement, FDA Commissioner Stephan Hahn said: “We understand that health care professionals are looking for every possible treatment option for their patients and we want to ensure we’re providing them with the appropriate information needed for them to make the best medical decisions.
“While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects of these medications that should be considered. We encourage health care professionals making individual patient decisions closely screen and monitor those patients to help mitigate these risks. The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available.”
The FDA has recently granted an emergency-use authorisation for the two drugs which are used to prevent malaria and treat lupus and rheumatoid arthritis. But it also noted the hazards of taking these drugs, saying it can cause heart-related issues and death.
Last week, the National Institutes of Health said that it “does not recommended” the hydroxychloroquine or chloroquine for treating COVID-19 due to a lack of evidence. This follows multiple clinical trials that have seen patients develop heart problems or die.
The most recent one came from France and included 181 patients in four hospitals, with all subjects in the trial having developed pneumonia as a result of COVID-19. Some patients developed irregular heartbeats from taking hydroxychloroquine meaning that the administered dose of the drug had to be stopped.
In another study coming out of Brazil, 11 patients died and many began suffering heart arrhythmias when being tested for higher doses of the drug.
The drug became well-known as a potential coronavirus treatment due to President Donald Trump calling it a “game changer.”
Conor Kavanagh
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