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 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 Organization decision on Monday to pause a large 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 United States has issued an emergency authorisation for the drug promoted by U.S. 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.
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 spokeswoman for its drugs regulator said.
No vaccine or treatment has been approved for COVID-19. — Reuters
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