The U.S. Food and Drug Administration (FDA) revoked the emergency use of chloroquine phosphate and hydroxychloroquine sulfate for COVID-19 patients, according to an FDA news release.
The drugs were donated to the Strategic National Stockpile for certain coronavirus patients who were hospitalized and either were not able to participate in clinical trials or where clinical trials were unavailable, the release stated.
“We’ve made clear throughout the public health emergency that our actions will be guided by science and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data and consider the balance of risks versus benefits of treatments for COVID-19,” FDA Deputy Commissioner for Medical and Scientific Affairs Dr. Anand Shah said in the press release. “The FDA always underpins its decision-making with the most trustworthy, high-quality, up-to-date evidence available. We will continue to examine all of the emergency use authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence.”
The FDA determined that the emergency use authorization criteria was no longer met and that the agency found the drugs were not likely to be an effective treatment for the virus.
The FDA also found that any benefits to using the drug combination were outweighed by the serious cardiac adverse events, as well as other potential side effects, that the combination caused.
Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation, said in the release that the agency was committed to finding ways to help patients.
“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate," Cavazzoni said in the release. "This action was taken following a rigorous assessment by scientists in our Center for Drug Evaluation and Research."
Cavazzoni said the agency's decisions would continue to be based on scientific data.
The drug combination was previously used to prevent malaria, while hydroxychloroquine was also approved to treat things like lupus and rheumatoid arthritis, the release stated.
