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.

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. 

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.

WHO cites safety concerns

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’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.

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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