Hyderabad: The US Food and Drug Administration (FDA) issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine for the treatment of COVID-19.
It is to be noted that these products are FDA-approved to treat or prevent malaria, and Hydroxychloroquine sulfate is also FDA-approved to treat lupus and rheumatoid arthritis. But they are not approved to treat COVID-19 patients.
FDA Commissioner Stephen M. 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."
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He further stated that while clinical trials are underway to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects of these medications and that should be considered.
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.
Once the FDA has approved a drug, health care providers generally may prescribe or administer the drug for an unapproved use, including in clinical settings not described in the approved labelling.
This decision will be based on their assessment of the potential benefits versus the risks for their patient, recognizing that the FDA has not assessed the safety or effectiveness of such use.
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For this reason, it is important that health care providers are aware of the risks of serious and potentially life-threatening heart rhythm problems that can occur with these drugs and are included in the drug labels for their approved uses.
It is pertinent to mention here that the FDA is an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
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