FDA Revokes Authorization For Use Of Antimalarial For Coronavirus

WASHINGTON, D.C. — On Monday, the U.S. Food and Drug Administration revoked its emergency use authorization for hydroxychloroquine to treat the coronavirus.

This is antimalarial drug touted by U.S. President Donald Trump to stave off the coronavirus. Based on new evidence, the FDA said it was no longer reasonable to believe that oral formulations of hydroxychloroquine and chloroquine may be effective in treating the illness caused by the novel coronavirus.

The request to revoke the authorization came from Gary Disbrow, deputy assistant secretary at the Biomedical Advanced Research and Development Authority.

The drug's anti-inflammatory and antiviral properties suggested it might help treat the coronavirus, and the FDA authorized its emergency use in March at the height of a pandemic.

Since then, several studies of the malaria pills showed hydroxychloroquine failed to prevent infection in people who had been exposed to the virus.

Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for health care providers that accompanies the drug to state that co-administration is not recommended.

The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to the drug.

In addition, the FDA revised the fact sheet for health care providers to clarify dosing and administration recommendations and to provide additional safety data and supporting data from clinical trials conducted by both the National Institutes of Health and the drug sponsor, Gilead Sciences Inc.

The fact sheet for patients and caregivers was also updated to include additional information about possible allergic reactions and to alert patients to tell their healthcare providers if they are taking chloroquine phosphate or hydroxychloroquine sulfate.

“Over the course of this unprecedented pandemic, the FDA has issued emergency use authorizations for a variety of medical products after evaluating the available scientific evidence and carefully balancing any known or potential risks against the benefits of making these products available during the current public health emergency," said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research. "We understand that, as we learn more about these products, changes may be necessary based on new data – such as Monday's updates for health care providers about a potential drug interaction and other important information about using remdesivir to treat COVID-19 patients.”

The new fact sheets for health care providers and patients now include information on possible side effects such as: increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and allergic reactions, which may include low blood pressure, high heart rate, low heart rate, shortness of breath, wheezing, angioedema (lip or tongue swelling), difficulty swallowing, rash, nausea, vomiting, sweating, shivering and respiratory distress.