FDA Permanently Pulled The Emergency Use Of Hydroxychloroquine

The USA Food and Drug Administration pulled its emergency authorization of hydroxychloroquine. FDA said that the anti-malarial drugs hydroxychloroquine and chloroquine is not effective in treating coronavirus. Apart from that, it may cause many side effects like heart complications. But President Donald Trump criticized the FDA and said, “I took it and I felt good about taking it. I don’t know if it had an impact, but it certainly didn’t hurt me.”  As per WHO’s list, hydroxychloroquine is an essential medicine and has been licensed by the USA in the 1950s.

FDA Permanently Pulled The Emergency Use Of Hydroxychloroquine

The decision announced by the FDA on Monday through a letter is based on new evidence that made it unreasonable to believe the effects of hydroxychloroquine and chloroquine. The drugs obtained by the National Stockpile will no longer be distributed to health authorities. The FDA has also warned the doctors for prescribing the drugs in combination with remdesivir. Remdesivir is a drug that currently shown to help patients with COVID-19. 

Both WHO and FDA halted the usage of anti-malarial drugs

WHO has already halted the usage of anti-malarial drugs against COVID-19. This was due to the reports that have shown a higher risk of death and heart problems in the patients taking hydroxychloroquine. The temporary pause of the WHO has not removed yet and now the FDA also pulled the usage.

There is no data or scientific proof that found them safe or effective for preventing or treating COVID-19 and these are the drugs approved for treating lupus and rheumatoid arthritis and malaria only. Even though, these antimalarial drugs will be available for alternative uses. Before pausing the usage, the FDA has warned the usage of these drugs and they cautioned that it should not be used outside of the hospital setting or a clinical trial due to the risk of heart rate problems. Despite FDA warnings, President Donald Trump said that he is taking anti-malarial drug hydroxychloroquine. He also avoided many other steps recommended by public health experts such as wearing masks.

The Lancet, popular health journal has published a study that shows the low survival rate in the hospitals using these drugs. But this study has retracted by the authors later.

Even after the warnings by the WHO and FDA Trump said there had been “great reports” out of France, Spain, and other places, without offering any evidence or further explanation. France is one of the countries that has already stopped using the drug for Covid-19 patients.

By the end of March, around 30m doses of hydroxychloroquine and chloroquine had been donated by two foreign drug manufacturers to the USA, and millions of those doses were shipped to US hospitals to treat patients who weren’t enrolled in clinical trials.

Since then, many studies were conducted and no large, rigorous studies have found the drugs safe or effective for preventing or treating Covid-19. Several studies found the side effects caused due to the usage of these drugs. The side effects and health issues caused are 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.

Dr. Steven Nissen, a Cleveland Clinic researcher who has been a frequent FDA adviser said, “There has never been any high-quality evidence suggesting that hydroxychloroquine is effective for treating or preventing coronavirus infection, but there was evidence of serious side effects.”

Due to the repeated promotions by Trump, the drug has faced a huge shortage in the USA and now the FDA has paused its usage. The only drug in the list of the FDA against COVID-19 is remdesivir form Gilead Science.