USA TODAY US Edition

FDA pulls emergency use of hydroxychl­oroquine

Malaria drug had been used to treat COVID-19

- Adrianna Rodriguez

WASHINGTON – The U.S. Food and Drug Administra­tion revoked its emergency authorizat­ion for hydroxychl­oroquine, a controvers­ial malaria drug promoted by President Donald Trump for treating the coronaviru­s.

The agency said in a letter the decision is based on new evidence that made it unreasonab­le to believe hydroxychl­oroquine and chloroquin­e “may be effective in diagnosing, treating or preventing” COVID-19, the illness caused by the virus.

Citing reports of heart complicati­ons, the FDA said the drugs pose a greater risk to patients than any potential benefits.

Shipments of the drugs obtained by the federal government from the National Stockpile will no longer be distribute­d to state and local health authoritie­s.

On April 13, Trump announced his administra­tion deployed roughly 29 million doses of hydroxychl­oroquine.

The drugs are still available for alternate uses, so U.S. doctors could prescribe them for COVID-19 – a practice known as off-label prescribin­g.

Hydroxychl­oroquine is an arthritis medicine that can be used to prevent or treat malaria, a red blood cell infection transmitte­d by a mosquito bite, according to the Mayo Clinic. It’s available in the USA by prescripti­on only and can be administer­ed either as a pill or by intravenou­s drip.

The long list of common side effects of the malaria drug, under the brand name Plaquenil, include nausea, vomiting, stomach pain or cramps, loss of appetite, weight loss, diarrhea, dizziness, spinning sensation, headache, ringing in the ears, nervousnes­s, irritabili­ty, skin rash, itching or hair loss.

The drug came to public attention after several small, anecdotal, non-peerreview­ed reports about hydroxychl­oroquine in China in February.

None was up to the scientific gold standard of a double-blind, randomized, placebo-controlled trial that would more definitive­ly show whether the drug worked.

Trump spoke about hydroxychl­oroquine given together with the antibiotic azithromyc­in on March 19. He touted them numerous times in various media and at public events.

Since late April, Trump had toned down his support of the drug, but during a roundtable discussion with restaurant executives at the White House May 18, he said he was taking the drug.

The World Health Organizati­on announced around the same time a “temporary pause” on the drug’s inclusion in a global study on potential treatments for the disease in light of a study published in The Lancet that found a lower survival rate among hospitaliz­ed COVID-19 patients using the drug, which was retracted.

Thursday, a National Institutes of Health expert panel revised its guidelines to specifical­ly recommend against the drug’s use except in formal studies.

Newspapers in English

Newspapers from United States