Close Supervision Needed for ‘Off-Label’ Antimalarial Drug Use

FDA encourages healthcare professionals to make individual patient decisions to mitigate health risks

doctor taking vitals of a patient

The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine that have been reported with their use for the treatment or prevention of COVID-19 disease.

As of April 24, 2020, 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.

“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, M.D. 

“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 healthcare 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.”

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. 

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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.

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 labeling. 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.

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.

The FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program:

  • Complete and submit the report online or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.

The FDA is an agency within the U.S. 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.

SARS-CoV-2 pandemic news published by CoronavirusToday.