FDA said these medicines have not been proven safe or effective for treating COVID-19. However, clinical trials are underway and additional trials are being planned to determine if these drugs can benefit patients with COVID-19.
The US Food and Drug Administration has issued a safety communication regarding the known side effects of malaria drug hydroxychloroquine and chloroquine touted by President Donald Trump for treating coronavirus.
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 (SNS) 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 hospitalized with COVID-19, as appropriate, when a clinical trial is not available or feasible.
The EUA requires that fact sheets with important information about using these drugs in treating COVID-19, including the known risks and drug interactions, as well as appropriate screening and monitoring, be made available to health care providers and patients, FDA said.
Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria. Hydroxychloroquine sulfate is also FDA-approved to treat lupus and rheumatoid arthritis. FDA said these medicines have not been proven safe or effective for treating COVID-19. However, clinical trials are underway and additional trials are being planned to determine if these drugs can benefit patients with COVID-19.
These trials are also examining whether the drugs can prevent COVID-19 among health care workers, first responders or people who have been in close contact with someone with COVID-19. Trump has been an advocate of use of this drug, which has reportedly cured a large number of patients in New York and several other place.
Reports indicates that the malaria drug has been effective during the initial phases of a person being infected by coronavirus but poses dangers to those having heart ailments.