FDA revokes emergency approval of hydroxychloroquine and chloroquine

pharmafile | June 16, 2020 | News story | Manufacturing and Production COVID-19, chloroquine, coronavirus, hydroxychloroquine 

The FDA has revoked its emergency approval of hydroxychloroquine and chloroquine due to health risks and a lack of effectiveness in treating COVID-19.

This emergency use authorization allowed the drugs to be donated to the Strategic National Stockpile to be used to treat coronavirus patients in hospital when they could not get the treatments through a clinical trial.

Dr Anand Shah, FDA Deputy Commissioner for Medical and Scientific Affairs, said 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.”

The FDA granted emergency use for the drugs in late March during the time where the US government accepted 30 million doses of the treatments from two different drug manufacturers. Millions of doses were then transported to US hospitals to treat patients.

Hydroxychloroquine and chloroquine have both been approved to treat or prevent malaria, with hydroxychloroquine also being approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis. It was thrown into the spotlight when President Trump started touting the drugs as effective coronavirus treatments, despite a lack of evidence. Trump has also claimed he has taken hydroxychloroquine to prevent getting the virus.

Responding to the FDA’s decision, the President said: “I took it and I felt good about taking it. I don’t know if it had an impact, but it certainly didn’t hurt me.”

There have been multiple contrasting studies looking into the drug’s safety and effectiveness in treating the virus but no conclusive clinical study data. However, the drug has been found to cause heart rhythm problems, severely low blood pressure and muscle or nerve damage, which has resulted in death. The FDA had reported that as of Monday, it had received 390 reports of complications from people taking the drug with 100 involving serious hear problems.

Dr Steven Nissen, a Cleveland Clinic researcher who has been a frequent FDA adviser, said: “There has never been any high-quality evidence suggesting that hydroxychloroquine is effective.”

In a separate announcement, the FDA also warned against prescribing hydroxychloroquine and chloroquine in combination with remdesivir, which is the only drug that is currently known to help COVID-19 symptoms.

Conor Kavanagh

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