FDA revokes usage of hydroxychloroquine promoted by Trump

US regulators recently revoked the emergency authorization for malaria drugs that were being promoted by Donald Trump against COVID-19. This is due to growing evidence that the drug doesn’t work towards curing or preventing the virus. However, it does come with side effects.

FDA stated that drugs like chloroquine and hydroxychloroquine are unlikely to show any results against coronavirus. The drug can lead to heart issues and consuming it can make things worse and pose risk.

FDA has warned doctors to not prescribe drugs that don’t have Remdesivir; the only drug that has shown potential cure in COVID-19 patients. FDA said that the anti-malaria drug can reduce the effectiveness of the Remdesivir. It is the same medicine that the FDA had cleared for emergency usage in May.

Chloroquine and hydroxychloroquine are often prescribed for rheumatoid arthritis and lupus. However, they can cause heart rhythm problems, muscle damage, nerve damage, and even lead to low blood pressure.

A new move by FDA

As per the agency’s reports, the FDA had received around 390 tests of complications due to drugs. 100 cases out of those were on heart issues. The reports represent an incomplete idea of complications due to drugs since many of the side effects aren’t noticed or reported.

The new move by FDA shows that the drugs that were being obtained and used by the federal government until now will not be distributed any longer. Neither state nor local health authorities are allowed to use these drugs against COVID-19. However, the anti-malaria drug is still going to be an alternative option but as a part of off-label prescribing practice.

Dr. Steven Nissen, a researcher from Cleveland Clinic and also an FDA adviser, agreed with the recent change. He said that he wouldn’t have granted the emergency access as well. He said that there hasn’t been any evidence that hydroxychloroquine is effective for preventing or treating coronavirus. However, there are serious side effects that have happened due to this drug.

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On June 11, the National Institutes of Health panel of experts went through the suggestions to recommend against the use of drugs in every case apart from formal studies. Nissen said that there is definitely an influence of the FDA in letting out such a statement.

The actions by NIH and FDA gave a clear idea to health professionals against recommending the drug for COVID-19.

Trump’s influence on the usage of hydroxychloroquine

Trump had pushed the idea of using hydroxychloroquine when the outbreak happened. He said that the drug was protecting him from the infection. Due to his influence, people started buying the drug and that led to supply shortage.

According to recent studies, the drug has not been proven to be anyway effective in curing or preventing coronavirus. It is causing more harm than expected damage control.

A former FDA associate commissioner, Dr. Peter Lurie said that the agency has tarnished its reputation by allowing the clearance of the drug based on vague evidence and due to political pressure.

The agency is credible due to scientific pronouncements stated Lurie. He was appointed by Obama during his governance and is now the president of a Center for Science in the Public Interest, a non-profit organization. He further said that this episode goes onto prove that scientific evidences are always safe and useful.

Usage of Remdesivir

Currently, the only drug that remains with the FDA against coronavirus is Remdesivir. It is an intravenous medication from the Gilead Sciences and has cured people who have been severely ill or hospitalized.

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On June 15, FDA announced that they will update the drug by prescribing label that warns people to not use it along with chloroquine and hydroxychloroquine. The drug apparently interferes with the virus-fighting ability of Remdesivir in human cells. Despite risks, there are still no harm or side effects reported by people.

FDA granted emergency usage of the anti-malaria drugs around late March. The US government accepted 30 million doses of chloroquine and hydroxychloroquine that was donated by two international drug manufacturers. Millions were shipped and sent to US hospitals for treating people who weren’t enrolled in clinical studies. However, the FDA did warn people about the dangerous side effects of heart issues, and problems were reported to the poison control centers.

The agency said that they revoke the usage after consulting with Biomedical Advanced Research and Development Authority, who had also requested the emergency usage. Former director of BARDA, Rick Bright, was sacked in April as he said he was under political pressure and had to spread the usage of the malaria drug. He said that he worked with the senior staff of the FDA to limit the authorization of the drug to patients who are hospitalized with coronavirus and kept under supervision.

Bright also said that some of the drugs were made in Pakistan and India, but did not go through the inspection of the FDA. The former director is seeking his reinstatement to his position in BARDA after he was transferred to NIH. However, the FDA stated that they tested the drugs that were imported to ensure their safety standards and quality.

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