COVID-19 Drugs: US FDA Finally Issues Warnings About Dangers Of Chloroquine And Hydroxyquine
: The US FDA finally on Friday warned doctors against prescribing a malaria drug touted by President Donald Trump for treating COVID-19.
A medical alert sent by the regulators flagged reports of sometimes fatal heart side effects among coronavirus patients taking hydroxychloroquine or the related drug chloroquine. The decades-old drugs, also prescribed for lupus and rheumatoid arthritis, can cause a number of side effects, including heart rhythm problems, severely low blood pressure and muscle or nerve damage.
The drug warning comes as doctors at a New York hospital published a report that heart rhythm abnormalities developed in most of 84 coronavirus patients treated with hydroxychloroquine and the antibiotic azithromycin, a combo Trump has promoted.
Chloroquine And Hydroxyquine are known to sometimes alter the heartbeat in dangerous ways, and their safety or ability to help people with COVID-19 is unknown. A National Institutes of Health experts panel earlier this week recommended against taking that drug combo except in a formal study because of the side effects potential.
Interestingly the very same US FDA authorized limited use of the malaria drugs for hospitalized patients with COVID-19 who aren't enrolled in ongoing research. The FDA said the drugs' risks are manageable when patients are carefully screened and monitored by doctors. A number of studies are testing hydroxychloroquine as a treatment or for prevention of COVID-19.
The US FDA said they are now investigating dangerous side effects and deaths reported with the malaria drugs to poison control centers and other health authorities.
A FDA spokesman said, "It is important that health care providers are aware of the risks of serious and potentially life-threatening heart rhythm problems that can occur with these drugs,"
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The regulatory agency did not specify the number of reports it has received of side effects or deaths.
Phone calls to US poison control centers about the malaria drugs increased last month according to Dr. Christopher Hoyte of the Rocky Mountain Poison Center in Denver, Colorado.
The typical problems reported include abnormal heart rhythms, seizures, nausea and vomiting, Hoyte said.
Preseident Trump has repeatedly touted hydroxychloroquine during his regular coronavirus briefings, suggesting its
skeptics would be proved wrong. He has offered patient testimonials that the drug is a lifesaver.
However a number of drug studies have suggested problems or no benefit.
In the latest drug research report in the journal Nature Medicine
, doctors at New York University and NYU Langone Health found a significant prolonging of what's called the heart's QT interval two to five days after coronavirus patients were given usual doses of hydroxychloroquine and azithromycin. The drugs can alter the QT interval, or the time it takes the heart to charge between beats. When that time is too long, it can trigger a rhythm problem that can lead to sudden death.
It was observed that nine of the 84 patients had severe prolongation of this interval. Four patients died from organ failure but there was no evidence heart problems contributed. Severe disease or other health problems may play a role in whether the heartbeat abnormality develops, the researchers speculated.
The research results show how important it is that these drugs only be used in a study where patients are closely tracked, said one independent expert, Dr. Rais Vohra, an emergency medicine specialist at the Fresno branch of the University of California, San Francisco.
Dr Vohra added, "That combination really sets you up for having a problem with the heart. My colleagues and I are concerned. People are self-medicating and coming down with very predictable side effects on the heart."
Also another recent analysis involving 368 patients in U.S. veterans hospitals found no benefit from hydroxychloroquine but instead more deaths. The report was not a rigorous test of the drug and results have not yet been reviewed by other scientists but are the largest so far of its use in COVID-19 patients.
Shockingly, the federal government accepted more than 30 million doses of hydroxychloroquine and chloroquine donated to the national stockpile by drugmakers Sandoz and Bayer. Since then, more than 20 million doses have been distributed to state and local health officials, according to the Department of Health and Human Services.
It should be noted that accepting the donation required sign off by both the FDA and the Biomedical Advanced Research and Development Authority, or BARDA, a unit of HHS that obtains treatments to combat bioterrorism and infectious diseases.
Interestingly earlier this week, former BARDA director, Rick Bright, said he was demoted from his job leading the agency because he resisted political pressure to allow widespread use of hydroxychloroquine. He has called for a federal investigation and reinstatement to his original job.
Thailand Medical News warns the public an dreaedrs that many big pharmaceutical companies in collaboration with governments are manipulation research studies and data to proceed ahead with their profit orientaed goals and for all to wary about drugs being promoted as experimental drugs for COVID-19 or as a possible treatment for COVID-19. Do you own intelligence and as a patient you do have the right to rejct drugs that you are not comfortable and also have the right to sue doctors, hospitals and government authorities for making you consume any drugs that can have side –effects.
To date they are no drugs that can cure COVID-19 disease and the only promising drug candidates or protocols so far that warrants more research and clinical trials are the combo Invermectin and Colchicine along with Traditional Chinese Medicine formulations and also a couple of supplements .
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