FDA ends emergency use of hydroxychloroquine

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Tuesday, June 16, 2020
FDA ends emergency use of hydroxychloroquine
U.S. regulators revoked emergency authorization for malaria drugs amid growing evidence they don't work and could cause serious side effects.

The Food and Drug Administration on Monday revoked emergency use authorization for giving the malaria drug hydroxychloroquine, and a related drug chloroquine, for COVID-19.

The drugs were heavily promoted by President Donald Trump for treating COVID-19

The FDA said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus.

Citing reports of heart complications, the FDA said the drugs' unproven benefits "do not outweigh the known and potential risks."

The FDA looked at several large clinical trials which have found the drug isn't showing benefit when it comes to treating covid19...

So it's no longer authorized as one of the drugs that can be used as an emergency or "last-ditch effort" drug.

Doctors can still use it off-label If they choose.

And it's still available for approved uses such as preventing malaria or treating lupus .

In a separate announcement, the FDA also warned doctors against prescribing the drugs in combination with remdesivir, the lone drug currently shown to help patients with COVID-19.

The FDA said the anti-malaria drugs can reduce the effectiveness of remdesivir, which FDA cleared for emergency use in May.

Also today, Cohen Children's Hospital published its report on treating 33 children with MIS-C, multisystem inflammatory syndrome in children, the COVID-related syndrome that's affected more than 200 children nationwide.

Many have said it is similar to Kawasaki disease or toxic shock, however, it's been determined to be a separate ailment.

Doctors are Cohen say the majority of cases had GI symptoms such as nausea, vomiting, diarrhea along with fever and red rash.

The good news is most kids recover with treatment.

Pennsylvania has 21 confirmed cases, with 16 more under investigation.

New Jersey on Tuesday announced 2 new cases, bringing the state's total to 42.

The Health Department said all tested positive for coronavirus, or had antibodies to it.

The children range from 1 to 18 years of age.

None of the children has died, however, 4 are still hospitalized.

Nemours duPont Hospital in Delaware has treated 7 children.