UPDATED on June 15, 2020
The Food and Drug Administration said on Monday that it was revoking emergency authorization of two malaria drugs to treat Covid-19 in hospitalized patients, saying that they are “unlikely to be effective” and could carry potential risks.
The drugs, hydroxychloroquine and chloroquine, were heavily promoted by President Trump after a handful of small, poorly controlled studies suggested that they could work against the disease caused by the coronavirus. Mr. Trump said he took hydroxychloroquine after he had been exposed to two people who tested positive for the coronavirus.
The agency said that after reviewing some data, it determined that the drugs, particularly hydroxychloroquine, did not demonstrate potential benefits that outweighed their risks. Earlier this spring, the F.D.A. had also issued a warning that the drugs could cause dangerous heart arrhythmias in Covid-19 patients.
Recent anecdotal reports and studies in test tubes have suggested that these compounds may also help treat COVID-19, the pandemic illness caused by the new Coronavirus. It was this news that caused recent shortages. On March 19, 2020, however, Mylan, a manufacturer of hydroxychloroquine, announced it would accelerate production in the United States, and Teva, another pharmaceutical company, announced that it will supply millions of doses to the United States. Other companies have also scaled up their production of their product, and we anticipate that shortages will soon be alleviated. Hydroxychloroquine (Plaquenil) is an anti-malarial medicine that can help individuals with rheumatoid arthritis and lupus. Both medications have anti-inflammatory properties and can be useful in treating joint inflammation and skin conditions associated with lupus.
Chinese and French researchers have found that hydroxychloroquine can be used to treat pneumonia resulting from the coronavirus. The results from preliminary studies were promising. To facilitate research, the World Health Organization is starting an international clinical trial of various medications that may serve as effective treatments for the coronavirus.
At a recent press conference, Donald Trump’s administration stated that hydroxychloroquine and various medications are being approved for testing as potential medicines for Covid-19 by the Food and Drug Administration (FDA). These drugs were previously considered for treating the viral disease during early tests on hydroxychloroquine in France. The medicine offered promising outcomes, and results showed that half of the patients who initially tested positive for the virus were cured after only three days of treatment. Though tests are still underway, it is vital to continue expanding our understanding of hydrochloroquine, as well as its side effects.
What is Covid-19?
Covid-19 is a novel (new) form of coronavirus. As with other viruses from the coronavirus family, this form has likely moved from animals to humans. The World Health Organization (WHO) recently declared the virus to be a pandemic.
What Are the Symptoms of Covid-19?
As indicated by the WHO, the most common symptoms of Covid-19 are fever, fatigue, and a dry cough. Some patients may also experience a runny nose, sore throat, or nasal congestion, as well as aches, pains, or diarrhea. About 80% of individuals infected with Covid-19 will experience minor symptoms like the common cold, and most will recover without special treatment. Recent research from France has found that Covid -19 may be cured with hydroxychloroquine and chloroquine.
What Is Hydroxychloroquine?
Hydroxychloroquine was first recognized by the FDA as an anti-malaria medication in the 1950s. It has since been used to treat a wide range of disorders, including systemic lupus erythematosus (commonly known as “lupus”), rheumatoid arthritis, Sjogren’s syndrome, and side effects of Lyme disease.
How Does It Work?
Scientists widely accept that these medications work at the molecular level to disrupt essential cell processes, weakening the body’s immune reaction. Since the natural immune response can cause inflammation and several side effects (including pain, fever, aches, and so on), this anti-immune drug is used to reduce common ailments like rheumatoid arthritis. However, it is still unknown how hydroxychloroquine works to treat malaria.
Research on Hydroxychloroquine as a Potential Treatment for Covid-19
In February, a team of researchers led by virologist Manli Wang from the Chinese Academy of Sciences decided to test hydroxychloroquine as a possible treatment for Covid-19. They found that hydroxychloroquine effectively blocked the spread of SARS-CoV-2 in cultured human cells. According to the New York Times, reports from China, South Korea, and France suggest that the treatment may be useful for human patients, and a few medical clinics in the U.S. have started regulating the medication. Furthermore, the FDA is arranging a substantial clinical trial for an official evaluation of the medicine’s properties, the Times revealed.
Nevertheless, there is a low supply of hydroxychloroquine in China, and an overdose can lead to drug abuse or death among humans. These facts led Wang’s group of researchers to look at a closely-related medication, hydroxychloroquine. Even though it has similar properties, hydroxychloroquine is less likely to lead to drug abuse than its chemical cousin. It is still widely accessible as a treatment for lupus and rheumatoid arthritis, as stated by the authors.
According to a report published on March 18 in the journal Cell Discovery, Wang’s research team tested hydroxychloroquine on primate cells. The results showed that, like chloroquine, the medication slowed SARS-CoV-2 replication. As of February 23, the Chinese Clinical Trial Registry had recorded seven clinical trials that tested the medication’s adequacy in combatting Covid-19, as noted.
In the US, the University of Minnesota is looking at whether taking hydroxychloroquine can help individuals whose family members have Covid-19 from contracting the illness themselves, as reported by the Times.
There is now a shortage of hydroxychloroquine due to high demand, as the American Society of Health-System Pharmacists has stated. However, on March 19, the pharmaceutical company Bayer gave three million tablets to the government, and Novartis, Mylan, and Teva are following suit, according to FiercePharma.
Since the results of these trials will not be immediate, the advantage of considering hydroxychloroquine as a medication for Covid-19 is that the medicine’s safety profile is well-known, Horovitz noted. According to the Centers for Disease Control and Prevention (CDC), both medications are usually well-tolerated at recommended dosages, but they may cause stomach pain, nausea, vomiting, migraines, and irritations. If consumed at high doses over a longer time frame, the medications can cause an uncommon eye condition called retinopathy.
Both of these medicines may interact with other medications, and dosage recommendations must take any possible interactions into account. Individuals with psoriasis, impaired kidney functioning, or liver problems are advised not to take this medicine, as reported by the Times. According to the CDC, individuals with heart arrhythmia should not take the medicine because it may worsen their symptoms.
“If these medications perform well in clinical trials and offer a powerful treatment for Covid-19, the FDA will help build the country’s inventory”, Hahn states.
According to a report by Hahn, “If clinical information acknowledges this drug as effective in treating Covid-19, we know there will be high demand for it.” He also said that the FDA would use all means possible to ensure chloroquine continues to be accessible for patients who take it to treat severe and dangerous diseases, such as lupus.
There is no doubt that scientists still have a lot of work to do before they can confirm the effectiveness of these medications for treating coronavirus. The medicines may be useful, but the question lies in their efficacy, safety, and long-term effects on patients. Nonetheless, if the scientific world can team up quickly enough to test these medications, and if the results prove to be as viable as they initially seem, this could be a turning point in the fight against the coronavirus pandemic.