5.28.2020

EU Countries bans Anti malaria drug for Coronavirus treatment


On Wednesday, The European Government ban the use of anti-malaria drug Hydroxychloroquine to treat COVID19 patients

The moves by France, Italy and Belgium followed a World Health Organization decision on Monday to pause an outsized trial of hydroxychloroquine thanks to safety concerns.

A UK regulator said on Wednesday that a separate trial was also being placed on hold, but every week after it started. 

The Research that was being led by the University of Oxford and was funded by the Melinda Gates foundation was likely to involve 40,000 health care workers.

According to an email  from the  Medicines and Healthcare products regulatory authority (MHRA)which was sent to the Reuters news agency stated that " All Hydroxycholorquine trials in COVID 19 remains under the close review as the Investigators asses any longer risks". 

The swift moves by authorities in countries hit hardest by the pandemic highlighted the challenge for governments scrambling to seek out ways to treat patients and control the novel coronavirus.

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

Trump was a very strong supporter, describing the drug as a “gamechanger.” He later announced he was taking it to stop infection.

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

On Wednesday, France’s health ministry cancelled a decree in situ for nearly two months that had allowed hospital doctors to dispense it in specific situations for COVID-19.

Medicines agencies in France and Italy said the drug shouldn't be used for COVID-19 outside clinical trials. Belgium’s regulator said trials getting to evaluate the drug should also take potential risks into consideration.

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

The Italian health authorities concluded that the risks, including little evidence hydroxychloroquine was beneficial against COVID-19, merited a ban outside of clinical trials.

“New clinical evidence on the utilization of hydroxychloroquine in subjects with SARS-CoV-2 infection ... indicates an increased risk for adverse reactions with little or no benefit,” medicines agency AIFA said.

The WHO said a security panel would evaluate by mid-June the drug’s use in its multi-country trial of potential COVID-19 treatments.

Germany is watching The Lancet study and therefore the WHO’s decision but has not made any decision about new guidance on hydroxychloroquine, a spokeswoman for its drugs regulator said.

The U.S. Food and Drug Administration has allowed healthcare providers to use hydroxychloroquine for COVID-19 through an emergency-use authorization, but has not approved them to treat it. It also warned in April, that for safety reasons, the drug should be used just for hospitalized COVID-19 patients or those in clinical trials.

The agency didn't answer queries asking whether it had been reconsidering the emergency-use authorization.

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