FDA Issues Warning About Hydroxychloroquine Over Heart Issues

New Delhi, April 28: The antimalarial drug hydroxychloroquine is being widely promoted as a “cure” for COVID-19, but we still lack good data on its true benefits. Some small clinical trials have shown possible benefits. But others have shown the opposite.
New trial finds drug didn’t improve outcomes. The FDA reissued a warning that people shouldn’t take the drug without a doctor’s supervision. The antimalarial drug hydroxychloroquine remains one of the most hyped potential treatments for COVID-19, especially on social media. However, claims about the effectiveness of this “miracle drug” against the new coronavirus have far outpaced the available clinical data. Some small clinical trials have shown possible benefits, while others have shown the opposite. Until we have results from larger, well-designed trials — which are currently underway — hydroxychloroquine and chloroquine should only be used under the close supervision of a physician.

On April 24, the FDA again warned consumers against taking hydroxychloroquine or chloroquine unless closely supervised by a healthcare professional, such as in a hospital setting or as part of a clinical trial.

This move comes after the agency received reports of “serious” side effects such as abnormal heart rhythms and rapid heart beats in COVID-19 patients who were treated with one of these drugs. In some cases, patients died.

The drugs were given either alone or in combination with the antibiotic azithromycin or other medicines. These drugs haven’t been approved by the FDA for the treatment of COVID-19.

Early results for hydroxychloroquine are not positive
Despite an early study finding evidence that hydroxychloroquine might help ease symptoms of COVID-19, subsequent studies have been less positive.

One of the first studies to suggest that hydroxychloroquine, in combination with the antibiotic azithromycin, might work as a treatment for COVID-19 was done in France.

The French study, though, had several design flaws, including its small size and how people were enrolled in the study.

Despite these flaws, results from this study were shared on social media as “proof” of the drug’s effectiveness.

Even President Donald Trump tweeted about the study. Since the study’s release, the journal in which the paper appeared issued a statement of concern about some aspects of the study’s design.

The New York Times later reported that Trump had a “small personal financial interest” in Sanofi, the French manufacturer that makes Plaquenil, the brand-name version of hydroxychloroquine.

In addition, results from other small trials and paper preprints suggest that hydroxychloroquine is not effective against COVID-19.

One part of a small study in Brazil was stopped early after COVID-19 patients taking a higher dose of chloroquine developed potentially fatal irregular heart rates.

The results were posted April 11 on medRxiv, an online server for sharing medical articles before they’ve undergone peer review by other researchers.

The higher-dose group of patients was given 600 milligrams of chloroquine twice daily for 10 days. By day six, 11 patients had died, leading researchers to stop this arm of the study early.

The lower dose group — 450 milligrams for 5 days, twice daily only on day one — didn’t have enough patients for researchers to know if the drug was effective for people with severe COVID-19.

A French retrospective study posted April 14 on medRxiv found that hydroxychloroquine didn’t help patients hospitalized with the coronavirus.

Doctors reviewed the records of 181 patients. About half had been given hydroxychloroquine within 48 hours of being admitted to the hospital.

Of patients taking the drug, 20.2 percent were admitted to the intensive care unit (ICU) or died within 7 days of hospitalization. Of those who didn’t take the drug, 22.1 percent went to the ICU or died.

Looking just at deaths, 2.8 percent of patients who were given hydroxychloroquine died within 7 days of hospitalization, while 4.6 percent of patients who didn’t take the drug died.

Neither of these differences was statistically significant, which means they could have occurred simply due to chance.

In another retrospective study of 368 patients posted April 21, researchers found that U.S. veterans taking hydroxychloroquine had a higher risk of dying compared to those not taking the drug.

Patients who received both hydroxychloroquine and azithromycin had a similar risk of dying compared to those who didn’t receive either.

Researchers also found that patients who were given one or both drugs had a similar risk of mechanical ventilation compared to people not taking either drug.

This wasn’t a randomized clinical trial. Instead, researchers reviewed the medical charts of patients who had already been treated. So there could be bias that affects the results.

Because papers posted on medRxiv haven’t undergone peer review, the results should be viewed with caution.

Newsweek also reported that hospitals in Sweden have stopped using chloroquine to treat people with COVID-19 after reports that it causes vision loss and blinding headache

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