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France, Italy, Belgium act to stop use of hydroxychloroquine for COVID-19 over safety fears

France, Italy and Belgium acted to halt the use of hydroxychloroquine to treat patients suffering from COVID-19, the illness caused by the novel coronavirus, amid questions about the safety of the generic anti-malaria drug.

The moves by three of the countries hardest hit by coronavirus infections and deaths follow a World Health Organization decision on Monday to pause a large trial of hydroxychloroquine due to safety concerns.

France on Wednesday cancelled a decree allowing hospital doctors to dispense the medicine, while the Italian Medicine Agency (AIFA) suspended authorization to use hydroxychloroquine for COVID-19 outside clinical trials.

Belgium’s medicine agency warned against using the drug to treat the virus, except within ongoing clinical registered trials. It said trials aiming to evaluate the drug should also take potential risks into consideration. 

A U.K. regulator said on Wednesday that a separate trial was also being put on hold, less than a week after its launch. The study, being led by the University of Oxford and partly funded by the Bill and Melinda Gates Foundation, was expected to involve as many as 40,000 health-care workers.

“All hydroxychloroquine trials in COVID-19 remain under close review” while investigators assess any further risks, the Medicines and Healthcare products Regulatory Agency (MHRA) said in an email to Reuters.

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 few months, killing more than 350,000 people 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.

Touted by Trump

After early reports that it might help some patients, regulators in several countries had allowed hydroxychloroquine to be used as a potential COVID-19 treatment.

U.S. President Donald Trump was a particularly strong supporter, describing the drug as a potential “game-changer” and announcing he was taking it to prevent infection.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Wednesday it seems clear that the drug is not a solution for treating COVID-19 patients. President Donald Trump has promoted the use of hydroxychloroquine. (Alex Brandon/The Associated Press)

However, more recent studies have raised serious safety issues. British medical journal The Lancet has reported coronavirus patients receiving hydroxychloroquine were more likely to die and experience dangerous irregular heartbeats.

Dr. Anthony Fauci, one of Trump’s health advisers as the director of the National Institute of Allergy and Infectious Diseases, told CNN in an interview on Wednesday that “the scientific data is really quite evident now about the lack of efficacy.”

France’s cancellation, which effectively bans use of 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 during hospital treatment of COVID-19.

The United States has issued an emergency authorization for the drug, which has been promoted by U.S. President Donald Trump, among others, as a possible coronavirus antidote.

A study in the British medical journal The Lancet suggested that patients getting hydroxychloroquine had increased death rates and irregular heartbeats, adding to several disappointing results for the drug as a COVID-19 option.

‘Increased risk for adverse reactions’

Italian health authorities have also 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.

Swiss drugmaker Novartis is pushing ahead with its U.S. study involving 440 patients, while French company Sanofi declined to comment on the future of its two trials.

The WHO said 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 new guidance on hydroxychloroquine, a spokesperson for its drug regulator said.

No vaccine or treatment has been approved for COVID-19.

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