Finally, US says no to hydroxychloroquine
The United States Food and Drug Administration has issued a safety communication regarding the known side effects of anti-malarial drug hydroxychloroquine, touted by President Donald Trump for treating coronavirus patients.
Washington: The United States Food and Drug Administration has issued a safety communication regarding the known side effects of anti-malarial drug hydroxychloroquine, touted by President Donald Trump for treating coronavirus patients.
The side effects include serious and potentially life-threatening heart rhythm problems.
The FDA in a Drug Safety Communication said that hydroxychloroquine has been given Emergency Use Authorisation for the treatment of patients who have tested positive with coronavirus.
These risks, FDA said are already in the drug labels for their approved uses and may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial.
"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," said FDA Commissioner Stephen M. Hahn.
"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," he said.
"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," Hann said.
FDA said as of now it has issued an emergency use authorisation to allow hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile to be distributed and used in limited circumstances, such as for certain hospitalised patients with COVID-19.
These drugs are able to be distributed from the SNS to states for doctors to prescribe to adolescent and adult patients hospitalised with COVID-19, as appropriate, when a clinical trial is not available or feasible.