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TUESDAY, June 16, 2020 (HealthDay News) -- The drugs promoted by President Donald Trump as treatments for COVID-19 should not be used with the experimental drug remdesivir because of a potentially unfavorable drug interaction, the U.S. Food and Drug Administration said.
The FDA in May gave emergency authorization for use of remdesivir to treat hospitalized, severely ill COVID-19 patients.
Recent research suggested remdesivir on its own isn't enough to curb the coronavirus, so scientists had been pinning their hopes on various drug combinations.
But in a revised fact sheet for health care providers, the FDA said a recently completed nonclinical laboratory study suggests that remdesivir shouldn't be used with the malaria drugs chloroquine or hydroxychloroquine.
"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 Dr. Patrizia Cavazzoni, 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 today's updates for health care providers about a potential drug interaction and other important information about using remdesivir to treat COVID-19 patients," Cavazzoni said in an agency news release.
The FDA said it's not aware of any cases of reduced remdesivir activity among patients who received the antiviral drug along with chloroquine or hydroxychloroquine, but is continuing to evaluate all data associated with remdesivir.
The announcement comes on the heels of another blow to hydroxychloroquine and chloroquine. On Monday, the FDA pulled its emergency approval for hydroxychloroquine and chloroquine as COVID-19 treatments, noting the risks outweigh the benefits. The agency said the medications should be reserved for clinical trials.
Trump touted the drugs as treatments for COVID-19. Moreover, he said he took hydroxychloroquine preventively after two White House staffers tested positive for the virus, despite no evidence of the drug's effectiveness against the illness.
The FDA's revised fact sheet for remdesivir clarifies dosing and administration recommendations. It also provides additional safety data and other findings from clinical trials conducted by the U.S. National Institutes of Health and remdesivir maker Gilead Sciences, Inc.
The updated fact sheet for patients and caregivers provides additional information about possible allergic reactions, including liver damage; low blood pressure; abnormal heart rate; vomiting; wheezing, and respiratory distress. And it alerts patients to inform their health care providers if they're taking chloroquine or hydroxychloroquine.
"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," Cavazzoni said.
Preliminary clinical trial results have shown that patients treated with remdesivir tend to have a faster recovery time, according to the FDA.
However, a major study published May 22 in the New England Journal of Medicine found that remdesivir alone won't be enough to curb cases and deaths significantly.
That study found that "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."
-- Robert Preidt
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