FDA Revokes Hydroxychloroquine Emergency Use Authorization

FDA Revokes Hydroxychloroquine Emergency Use Authorization

The U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization for chloroquine and hydroxychloroquine to treat hospitalized COVID-19 patients. The agency is ending the emergency use of the antimalarial medication because the risks outweigh any known benefits.

The treatment gained support from the administration in May, including distribution of more than 19 million hydroxychloroquine doses from the National Stockpile to the Department of Veterans Affairs, Department of Defense and several U.S. cities. The drugs failed in several clinical trails and have been found to possibly cause serious heart problems.

The FDA issued the EUA for certain patients with COVID-19 in March. The following month, the FDA and the NIH came out warning against its use.

Studies released in April issued further warnings that HCQ is ineffective as a treatment measure, and one of the studies said HCQ increases the risk of cardiac arrest in COVID-19 patients by more than 2x and was tied to other serious side effects. The drug also did not reduce the need for mechanical ventilation in patients with severe COVID-19 symptoms, nor has it been proven effective as a preventative medicine against coronavirus.

FDA deems Hydroxychloroquine Ineffective, Revokes EUA for COVID-19

The FDA statement says “it is no longer reasonable” to believe the medications are effective for this purpose and that known and potential risks outweigh known and potential benefits. The FDA has determined that chloroquine and hydroxychloroquine “are unlikely to be effective in treating COVID-19 … (and) may cause serious cardiac adverse events and other side effects.”

A 28-day study of 150 COVID-19 patients performed at Shanghai Jia Hong University School of Medicine was halted as a result of findings that patients treated with hydroxychloroquine did not fare any better than patients who did not get the drug.

Here is the FDA’s FAQ on the revocation of its hydroxychloroquine emergency authorization.

The FDA announced the EUA withdrawal in a letter to the Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response (ASPR), and U.S. Department of Health and Human Services (HHS). Here is the letter explaining the decision to revoke emergency use authorization for HCQ.

Remdesivir, Dexamethasone only available drug treatments for COVID-19

In May, the FDA and NIH approved anti-viral drug remdesivir for treatment of hospitalized COVID-19 patients. The drug, which is being studied in clinical trials globally, is believed to decrease viral RNA production in COVID-19 disease, thus limiting replication and proliferation of the infection.

In the U.K., the NHS this week approved the use of anti-inflammatory drug dexamethasone in the fight against the deadly virus. The low-dose steroid treatment is part of the world’s biggest trial testing existing treatments to see if they also work for coronavirus.

Dexamethasone cut the risk of death by 1/3 for patients on ventilators, and cut deaths by 1/5 for patients on oxygen. The drug is already used to reduce inflammation in a range of conditions, including arthritis, asthma and some immune system and hormone disorders.

It appears to help stop some of the damage that can happen when the body’s immune system goes into overdrive, or cytokine storms, as it tries to fight off coronavirus.


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