The US Food and Drug Administration is a step closer to a potential approval of chloroquine for treatment against Covid-19, while more doubts over the drug’s effectiveness and concerns over lethal side effects continue to pop up around the globe.
Chloroquine, an anti-malarial drug touted by US President Donald Trump as a “game changer” and potential treatment for the coronavirus, made headlines after a Jewish doctor in New York said he had successfully treated the symptoms of coronavirus patients using a mixture of hydroxychloroquine sulfate, zinc, and azithromycin.
A French scientist has also been pushing for chloroquine-based treatment for coronavirus, while health officials challenged his findings due to a lack of a control group to validate results.
This prompted French President Emmanuel Macron to fly down to Marseille last week unexpectedly to have a conversation with the doctor, according to Politico.
But Chinese authorities have cautioned doctors and health officials about the drug’s side effects, calling on health administrations to monitor closely any adverse effects including rapid death that could result from even a moderately low overdosage.
Cyprus in the mix
Last week, an Israeli military plane delivered five tons of the active ingredients to Cyprus, where a local pharmaceutical company said it would manufacture and ship chloroquine to Israel.
Teva Pharmaceutical Industries, an Israeli-based company in India, had promised to donate more than 10 million tablets of hydroxychloroquine sulfate, a less toxic version of chloroquine, to hospitals across the United States.
US makes review of chloroquine a priority
According to Reuters, the FDA is currently prioritizing review of newly submitted Abbreviated New Drug Applications, a process designed for generic drug approval for an existing licensed medication or approved drug.
This week, the FDA published a product-specific guidance on tis website to support generic drug development for chloroquine phosphate and hydroxychloroquine sulfate.
“Given the anticipated increase in demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available for patients,” an FDA press release said on Monday.
Uncertainty over symptoms
But the controversial drug comes with symptoms of its own, with some patients experiencing only mild symptoms while others seeing their health deteriorate.
An American famous couple, Tom Hanks and Rita Wilson who recently became Greek dual citizens, made headlines early on in the outbreak of the coronavirus after they both tested positive and were given chloroquine.
Wilson said she became “completely nauseous” and “very tired, extremely achy, uncomfortable, didn’t want to be touched.” She also said she suffered from the loss of her senses of taste and smell, getting the chills and a 102-degree fever (38.8 Celsius).
But Hanks did not experience the loss of taste and smell or the high fever, according to Wilson.
Brazil team halts chloroquine study
Brazilian scientists this week said they may have an answer but also more questions over the use of chloroquine.
According to foreign media, a scientific study on the use of chloroquine as a potential treatment for the novel coronavirus was halted in Brazil after heart rhythm irregularities developed in people who had been given the higher of two doses.
The team of researchers said they were forced to halt the chloroquine study early after “potential safety hazards” became apparent, with preliminary findings suggesting that a 10-day regimen should not be recommended for COVID-19.
According to the Associated Press, the team planned to enroll 440 severely ill COVID-19 patients to test two doses of chloroquine, but researchers reported results after only 81 had been treated.
No control group in Brazil study
A quarter of those assigned to get 600 milligrams twice a day for 10 days developed heart rhythm problems, and trends suggested more deaths were occurring in that group, so scientists pulled the plug on the study prematurely while reports pointed out they also had no comparison group that was getting no treatment.
The other group was given 450 milligrams twice a day on the first day then once a day for four more days.
In the Republic of Cyprus, some infected patients with the novel coronavirus, who were otherwise healthy, have died in hospital. It was not clear whether they had received chloroquine and whether it had been effective. Local media have confirmed that the drug has been used in state hospitals in combination with other medical drugs during the coronavirus outbreak.
Doctors and hospitals around the world have since began clinical trials based on early signs that the experimental antiviral treatment for people who become very sick from the coronavirus may work fairly quickly by blocking the virus from reproducing itself in the body.
Health Minister Constantinos Ioannou, who announced in late March that Cyprus was moving forward with the production of chloroquine quantities, also made it clear that “at present stage there is no approved treatment to deal with the coronavirus.”