The FDA has revoked emergency use authorization (EUA) of the malaria drug hydroxychloroquine after several trials proved it to be ineffective in treating coronavirus. A study in the New England Journal of Medicine showed that the use of hydroxychloroquine did not decrease the need for ventilators nor the risk of death. Another study published in The Lancet found that patients treated with hydroxychloroquine had a higher death risk than those who were not treated with the drug.
Trials also revealed that hydroxychloroquine could reduce the effectiveness of the antiviral drug remdesivir, which has been proven to help those with severe cases of COVID-19 recover faster. The FDA stated that the risks of the drug outweigh the benefits, and that they had already received 390 reports of complications, many involving heart problems.
When the coronavirus outbreak was at its peak, the FDA gave quick approval for emergency use of the antimalarial drug in conjunction with the antibiotic azithromycin (Z-pack) for use in hospital settings in severe cases. Trump stated in March that the combination had “a real chance to be one of the biggest game changers in the history of medicine.” However, the drug was not to be used as a preventative for COVID-19, but only for use in clinical trials and emergency situations.
Then, President Trump began actively touting the drug and stating that he was taking it. Trump stated, “What do you have to lose? Take it.” Orders for the drug were in the millions, the drug was widely prescribed, leading to shortages. Now, hospitals and the VA have millions of doses of the drug that will go to no use.
The government had distributed a total of 31 million hydroxychloroquine tablets donated by drug companies to hospitals across the U.S. Now, 63 million tablets are left over with nowhere to go. The U.S. had even sent 2 million doses to Brazil, where the pandemic is hugely prevalent.
Trump is now criticizing the FDA for their decision to revoke the drug, even in the wake of many trials that proved it ineffective and even harmful. Trump claims that only U.S. agencies have failed to appreciate hydoxychloroquine’s benefit, even as a large British trial was halted this month, and France, Italy, and Belgium have stopped use of the drug.
What is hydroxychloroquine?
Hydroxychloroquine was discovered in the 1930s and its components come from the bark of the quinine tree. It’s a decades-old drug that has antiviral and anti-inflammatory properties. It’s used for malaria, rheumatoid arthritis, lupus, and other conditions, but its use has become more rare due to several potentially dangerous side effects such as heart rhythm problems, extremely low blood pressure, and muscle and nerve damage. Other extreme side effects of the antimalarial drug can include cardiac arrest for those with heart problems or lethal reactions for those taking antidepressants.
Despite the revoking of emergency use authorization for COVID-19, the drug is still available for use for other conditions, and can be prescribed by a doctor for any use. There are still U.S. trials underway testing the efficacy of the drug.