France, Italy and Belgium acted to halt the use of hydroxychloroquine to treat patients suffering from Covid-19, the illness caused by the new coronavirus, amid questions about the safety of the generic anti-malaria drug.
Yesterday France cancelled a decree allowing hospital doctors to dispense the medicine, while the Italian Medicine Agency (AIFA) suspended authorisation to use hydroxychloroquine for Covid-19 outside clinical trials.
Belgium’s medicine agency warned against using the drug to treat the virus any more except within ongoing clinical registered trials.
It said trials aiming to evaluate the drug should also take potential risks into consideration.
The sudden changes highlight the challenge for governments as they scramble to find ways to treat patients and control a virus that has spread rapidly around the world over the past three months, killing more than 350,000 and infecting millions.
It also illustrates at least a temporary about-face for regulators on a drug that at the outset of the pandemic had been seen as a promising treatment option.
The moves by three of the countries hardest hit by coronavirus infections and deaths follow a World Health Organisation (WHO) decision on Monday to pause a trial of hydroxychloroquine due to safety concerns.
France’s cancellation, which effectively bans the drug for Covid-19, was confirmed by the health ministry.
It did not refer to the WHO suspension.
France in March allowed the use of hydroxychloroquine – which beyond malaria is approved to treat lupus and rheumatoid arthritis – in specific situations for hospital treatment of Covid-19.
The US has issued an emergency authorisation for the drug promoted by US President Donald Trump, among others, as a possible coronavirus antidote.
British medical journal The Lancet has reported patients getting hydroxychloroquine had increased death rates and irregular heartbeats, adding to several disappointing results for the drug as a Covid-19 option.
Italian health authorities concluded that the risks, coupled with little evidence hydroxychloroquine was beneficial against Covid-19, merited a ban outside of clinical trials.
“New clinical evidence on the use of hydroxychloroquine in subjects with Sars-CoV-2 infection ... indicates an increased risk for adverse reactions with little or no benefit,” AIFA said, using the full name of the disease.
The WHO said that a safety panel would act by mid-June to evaluate the drug’s use in its multi-country trial of potential Covid-19 treatments.
Germany is looking at The Lancet study and the WHO’s decision but has not made any decision about hydroxychloroquine, a spokeswoman for its drugs regulator said.
No vaccine or treatment has been approved for Covid-19.
In France, a infectious disease specialist has insisted that he has successfully treated some 4,000 patients by using hydroxychloroquine with the antibiotic azithromycin.
The doctor, Didier Raoult, has caught the ear of Trump, who stunned his own administration last week by revealing he was taking hydroxychloroquine as a preventive measure against Covid-19.
Raoult has already rejected a comprehensive study published last week in The Lancet medical journal, which found that administering hydroxychloroquine or its related compound chloroquine actually increased the risk of dying for many patients.
Under the new French rules, the drug should be used only in clinical trials.
Its use is not prohibited outright, and doctors working in hospitals would still be able to prescribe it off-label as a coronavirus treatment.
“In fact, it means that you’re not allowed to recommend it, but I have never recommended it – I have said what I was going to do,” Raoult told Sud Radio of the government intervention yesterday.
“I don’t think this changes anything much, especially since there are not that many Covid-19 cases left,” he said.
His clinic, meanwhile, told AFP it would “continue treating patients with the most appropriate treatment”.
It was not the first provocative statement from Raoult, whose defiant stance has made him a mainstay in the French media, about a disease that has caused more than 28,000 deaths in France in a matter of months.
In April, health officials denounced his claim that the outbreak was easing, which according to Raoult proved that “it’s a fairly commonplace” respiratory disease.
Hydroxychloroquine, also used to treat malaria, is sold under the brand name Plaquenil by French pharma giant Sanofi, which promised to offer governments millions of doses if studies proved that it could be safely used in the coronavirus fight.
It has long been known to produce serious side effects, including heart arrhythmia, in some people.
US regulators have also advised against taking the drug because of health risks, but that has not deterred Trump, who said last week that “I’ve heard a lot of good stories” about its potential in the coronavirus fight.
Brazil’s President Jair Bolsonaro is also promoting hydroxychloroquine, and the country’s health ministry said on Monday that it would keep recommending it despite the WHO suspending trials.
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