The U.S. Food and Drug Administration (FDA) has said that a combination of hydroxychloroquine and remdesivir should not be used in patients with COVID-19 because of a potentially dangerous drug interaction.
The agency warned that hydroxychloroquine and chloroquine could reduce the efficacy of remdesivir, an antiviral drug developed by Gilead Sciences.
Sold under the brand name Plaquenil, hydroxychloroquine is used for the treatment and prevention of malaria. It is also used to treat the symptoms of lupus and rheumatoid arthritis.
Remdesivir, which was originally developed for the treatment of Ebola, has been found effective at treating COVID-19. Last month, the FDA gave Emergency Use Authorization (EUA) of remdesivir to treat severely ill, hospitalized COVID-19 patients.
Studies have suggested that remdesivir alone is not enough to curb the coronavirus, so researchers have been trying various drug combinations.
And now, in a revised fact sheet for doctors, the agency said remdesivir should be advised along with malarial drugs hydroxychloroquine and chloroquine, citing the findings of a recent study that showed the combination of these drugs led to a potentially dangerous drug interaction.
Dr. Patrizia Cavazzoni, Acting Director of the FDA’s Center for Drug Evaluation and Research, said, “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.”
“We understand that, as we learn more about these products, changes may be necessary based on new data, such as today’s updates for health care providers about a potential drug interaction and other important information about using remdesivir to treat COVID-19 patients,” she added.
The agency’s announcement is yet another blow to hydroxychloroquine and chloroquine. On Monday, the FDA revoked its EUA for hydroxychloroquine and chloroquine as COVID-19 treatments, citing the potential risks on cardiovascular health.
“As we have done throughout the pandemic, the FDA continues to evaluate all of the emergency use authorizations issued and their related materials and will continue to make changes as appropriate based on emerging science and data,” Dr. Cavazzoni said.
The FDA said preliminary findings have shown that COVID-19 patients who were given remdesivir tend to recover within a shorter period. However, one study, published last month in the New England Journal of Medicine, found that remdesivir alone is not enough. The study author said, “Given high mortality [of patients] despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient.”
