The US 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 potentiallylife-threatening heart rhythm problems.
The FDA in a Drug Safety Communication said thathydroxychloroquine has been given Emergency Use Authorisation for the treatmentof patients who have tested positive with coronavirus.
These risks, FDA said are already in the drug labels fortheir approved uses and may be mitigated when health care professionals closelyscreen and supervise these patients such as in a hospital setting or a clinicaltrial.
“We understand that health care professionals are lookingfor every possible treatment option for their patients and we want to ensurewe’re providing them with the appropriate information needed for them to makethe best medical decisions,” said FDA Commissioner Stephen M. Hahn.
FDA said as of now it has issued an emergency useauthorisation to allow hydroxychloroquine and chloroquine products donated tothe Strategic National Stockpile (SNS) to be distributed and used in limitedcircumstances, such as for certain hospitalised patients with COVID-19.
These drugs are able to be distributed from the SNS tostates for doctors to prescribe to adolescent and adult patients hospitalizedwith COVID-19, as appropriate, when a clinical trial is not available orfeasible.
The EUA requires that fact sheets with important informationabout using these drugs in treating COVID-19, including the known risks anddrug interactions, as well as appropriate screening and monitoring, be madeavailable to health care providers and patients, FDA said.
Hydroxychloroquine and chloroquine are FDA-approved to treator prevent malaria. Hydroxychloroquine sulfate is also FDA-approved to treatlupus and rheumatoid arthritis.FDA said thesemedicines have not been proven safe or effective for treating COVID-19. However, clinical trials are underway andadditional trials are being planned to determine if these drugs can benefitpatients with COVID-19.