With hydroxychloroquine, the story is never over till it’s over. The US Food and Drug Administration has revoked the emergency use authorisation (EUA) it had given the drug for use in Covid-19 cases.
In a directive, the USFDA said hydroxychloroquine and chloroquine were “unlikely” to be effective against Covid-19, as seen from the ongoing analysis of the EUA and emerging scientific data. “Additionally, in light of the ongoing serious cardiac adverse events and other potential serious side-effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorised use,” the agency added.
In a separate note, the FDA further warned healthcare providers “about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir,” which has an EUA for the treatment of hospitalised Covid-19 patients with severe disease.
The latest action comes after a long list of confusing signals from various authorities and scientific studies and journals on the use of this drug. All this has played out in full public view and across geographies after US President Donald Trump catapulted hydroxychloroquine into the spotlight as a possible game-changer against Covid-19.
In fact, the USFDA revocation, too, elicited a response from the US President who, according to a foreign media report, said: “Only US agencies have failed to grasp its benefit in fighting the coronavirus.”
Use in India
Clearing the air on the use of the drug as a Covid-19 preventive in India, Shashank Joshi, endocrinologist and member of Maharashtra’s Covid taskforce, said: “The US, Europe and WHO’s use of this drug for Covid-19 was double the dose and duration than that in India.”
In India, it is a preventive given to close family members of Covid-19 patients and to healthcare workers. It is also used in Covid-19 treatment at an early stage. “This prevents the disease from progressing and causing further lung damage,” he said, emphasising that it was safe for use under a doctor’s watch. The drug is given to people with rheumatoid arthritis and lupus, and in the last three years, he said, it has been given to people with Type II diabetes as well.
With this being the safety profile of the off-patent, inexpensive drug, he said, the use is likely to continue in-line with existing guidelines from the Indian Council of Medical Research.
Scientific controversy
Hydroxychloroquine has not had a dull moment in over two months, and the US President’s interest had even landed it in a diplomatic tangle. The US had asked India for the drug just as India banned its export, causing much heartburn to Indian drugmakers like Ipca and Zydus Cadila. But those wrinkles too were ironed out, and the first shipment was exported from India to the US by Israeli drugmaker Teva.
But these rapidly unfolding events too became history as scientific studies on the drug did a fresh flip-flop on its safety profile. And this controversy truly exploded when medical journals Lancet and the New England Journal of Medicine retracted studies that had red-flagged safety issues on the use of the drug used in fighting Covid-19. Following the retraction, WHO reinstated the drug in its ‘Solidarity’ trial on probable Covid-19 drugs.