Officially ..FDA approves the emergency license for the remdisiver medicine to treat patients with SK

The US Food and Drug Administration (FDA) has issued a formal authorization for the use of emergency medication to treat “REMDIVIVIR” antiviral drugs for the treatment of suspected or clinically confirmed COVID-19 patients in adults and children in hospitals with severe illness.

The Food and Drug Administration emergency statement for remdesivir, which came two days after the clinical experience of the National Institutes of Health promising results, is an important step forward in the fight against the Corona virus.

FDA approval for the drug Reimserv

Permission to use in emergency situations allows the distribution of remdesivir to treat suspected or confirmed laboratory corona patients in adults and children in hospitals with severe disease, and severe disease is defined as patients with low levels of oxygen in the blood or need oxygen therapy or breathing support More intense like a ventilator.

The text of the FDA statement reads on its official website: “Based on the evaluation of emergency use licensing standards and available scientific evidence, it has been determined that it is reasonable to believe that Remdesivir may be effective in treating COVID-19, and that, as there are no appropriate, approved, or available alternative therapies available, Known and potential benefits of treating this dangerous or life-threatening virus Currently known and potential risks of drug use.


Emphasizing that important information on the use of remdesivir in the treatment of COVID-19 is available to healthcare providers and patients, including dosage instructions, possible side effects and drug interactions. Possible side effects of remedivir include: Increased levels of liver enzymes, which may be a sign of inflammation or damage to liver cells. And leak-related reactions, which may include low blood pressure, nausea, vomiting, sweating and tremors.

The FDA previously allowed study of the investigative drug under clinical trials, as well as extended use for individual patients and through a multi-patient expanded access program coordinated by Gilead Corporation.


FDA Warns About Drug Poisoning That Trump Promotes

(NEWS NOW) .- The Food and Drug Administration (FDA) warned of poisoning and death from the drugs chloroquine and hydroxychloroquine, which Donald Trump has consistently promoted as a Covid-19 treatment despite there being no evidence in this regard.

PHOTO: Alex Wong / Getty Images

READ: Trump suggests disinfecting the lungs with … chlorox?

These medications are used to treat malaria, but have been used by the public in unsupervised Coronavirus cases or prescription, and out of clinical trials, which has resulted in fatal situations.

The agency indicated that they received reports from Covid-19 patients who suffered from “severe heart rate problems” when using malaria medications in combination with azithromycin, an antibiotic known as Z-Pak.

Hydroxychloroquine and chloroquine can cause abnormal heart rates such as QT prolongation interval and dangerously fast heart rate, called ventricular tachycardiaThe FDA wrote in an announcement this Friday, April 24.

The statement also indicated that the agency will continue to investigate the risks associated with the use of these medications in the treatment of Covid-19. He also recommended that doctors not prescribe them to Coronavirus patients outside of a hospital.

READ: Local doctor accused of selling “miracle cure” for COVID-19

A study published in the Journal of the American Medical Association this Friday indicates that researchers had to stop a study on the potential use of chloroquine in patients with Coronavirus, due to concerns for the safety of patients.

In this study, some patients developed irregular heart rates and almost 24 people died after taking doses of chloroquine every day as a Covid-19 treatment.

The FDA clarified that those who are taking these medications to treat diseases such as malaria or autoimmune conditions like lupus, they should continue taking your medicine as prescribed.

Until now there is no proven treatment for Covid-19 and any authority figure who says otherwise and promote medicines without any scientific support is putting people’s lives at risk, especially when the president of the United States says so.

READ: FL receives chloroquine: a drug that is not approved against COVID-19


How Paul Romer wants to save America’s economy

FThere is only one way for economist Paul Romer to get America’s economy going again as long as no coronavirus vaccine is found and available to everyone: everyone needs to be tested, as soon as possible. The Nobel Memorial Prize for Economics considers 30 million tests a day feasible in terms of production technology. The carriers of the virus would have to be isolated.

Winand von Petersdorff-Campen

Romer sees no alternative to his plan. As long as people were afraid of getting infected, they delayed consumption and investment decisions and returned to work, even if the governors relaxed the requirements. Lifting restrictions without a real exit plan harbors the risk that the virus will return to its path of exponential growth with catastrophic consequences for the economy and new deadly dangers for humans. Fears and insecurity would paralyze people in such a comeback of the pandemic, even if they were allowed unlimited mobility again.

Testing until everyone is vaccinated?

The sheer number of tests that Romer considers necessary seem utopian. Between 150,000 and 175,000 people are currently screened each day in the United States. According to the economist’s analysis, two problems hamper the mass production of the tests: the requirements and the bureaucratic toughness of the FDA, and the lack of financial incentive for the laboratories to carry out the tests. Laboratories could achieve the desired number of tests uninhibited by tight conditions and financially secure. “This nation produces 350 million cans of Cola Fanta and other soft drinks a day. If we can do that, we can also produce 30 million tests a day, ”Romer said in the CNN interview.

Romer with his Nobel Prize in Stockholm in December 2018

The FDA should quickly approve procedures that show the same level of precision as previously approved tests. According to Romer’s rough estimate, the state would have to provide around $ 100 billion a year for universities, hospitals and companies to multiply the American test capacity. He has identified 36 laboratories in America that are eligible for testing based on their experience and capabilities in DNA sequencing. Romer’s goal is to build enough capacity to fully test the 330 million Americans once a week. He would test again and again until everyone was vaccinated. He does not expect this to happen in the next 15 to 18 months.

Treat people with symptoms like sick people

Romer is hoping for new saliva test methods that, according to the latest research from Yale University, show the same or even better diagnostic quality than the smears from the nose that were previously considered the gold standard. They are apparently easier to scale than smear procedures. “The only question is whether Congress is committed to restoring confidence in the health of our citizens and the economy to start the recovery,” Romer writes verbatim.

The former chief economist of the World Bank sees the major problem that the United States not only did far too few tests, but wasted limited resources by testing the wrong people. Romer would not test people with symptoms, but treat them as sick people with proven infection. He would initially reserve the tests for doctors, nurses and nurses who are involved in the fight against the pandemic in order to minimize mutual infection. When mass production started, he would test workers in vital jobs, such as supermarket or police officers. Those who tested positive, their relatives and close employees would have to be isolated.

The economic calculation of this approach is clearly positive: Every month the United States loses $ 500 billion in added value due to the standstill. The $ 100 billion he calculated for building up the mass test capacity was also worthwhile because the corona virus was threatened by even more deadly pandemics. Romer rejects an alternative strategy that relies on antibody tests to measure whether someone has ever developed Covid-19. The procedures are too imprecise, and it is not yet clear whether even the sick could not be infected again.


Scientists in the United States look for inhibitors of an enzyme that helps the coronavirus

Miami – Based on a discovery by Puerto Rican professor Mariano García Blanco, scientists from universities in Florida and Texas, and from the National Cancer Institute of the United States, are working together in search of a medicine that blocks an enzyme that helps the COVID-19 to multiply in the human body.

Florida International University (FIU) reported Monday that the team’s goal is to discover among the existing and approved drugs in the United States which are the ones that best inhibit the enzyme Topoisomerase III-ß (TOP3B), for which they help with artificial intelligence and molecular models.

García Blanco, a specialist in biochemistry and molecular biophysics trained at Harvard and Yale, and currently a professor at the University of Texas Medical Branch (UTMB) in Galveston, discovered that this enzyme is used by COVID-19 to multiply in the human body, he reported in an article published last month.

Virus factories

With the help of the enzyme TOP3B, COVID-19 replicates (makes copies of itself) within infected human cells, which thus becomes a “virus factory”, as published in the specialist journal BioRxvy.

Following his discovery, García-Blanco enlisted the help of the director of the FIU Institute of Biomolecular Sciences, Yuk-Ching Tse-Dinh, an internationally recognized topoisomerase expert, and deputy director Prem Chapagain.

“We are approaching FIU as the place where the best inhibitors come from,” Garcia-Blanco said in remarks reproduced in the FIU statement.

Tests with medications already approved

Tse-Dinh is testing drugs already approved by the United States Food and Drug Administration (FDA) because what is sought is something that can be tested in patients quickly, to prevent COVID-19 from spreading throughout the world .

We are aiming to stop the TOP3B enzyme from working inside the cell, as the virus will not spread as well as it does, Tse-Dinh said.

In the opinion of the scientific team, if they find a good inhibitor, COVID-19 patients can be applied together with antiviral drugs in order to expand the recovery opportunities of those who are very serious.

Real solutions for the biggest challenge

According to Mike Heithaus, dean of the FIU College of Arts, Sciences and Education, they are looking for real and tangible solutions to the “greatest challenge of our time” and if they succeed, this new approach could be used to treat other viruses and new ones. may arise. Tse-Dinh, Chapagain and two graduate students, Ahmed Seddek and Tumpa Dasgupta, are already identifying drugs using artificial intelligence and molecular models and testing them as potential enzyme inhibitors. When they find one with potential, they are forwarded to García-Blanco and his team, who test them in cell cultures and viruses, including COVID-19. “It is a very simple story. We want to block this enzyme. That’s all. If we can do it and combine it with another antiviral treatment, we may have more opportunities to help people who are very ill,” said García-Blanco. In the midst of the pandemic, research participants are working piecemeal in their labs or some of them from home to achieve the goal. “We feel the urgency, but we have to do things scientifically,” said Tse-Dinh. Something similar in Brazil

In Brazil, a group of researchers found that Atazanavir, a drug used to treat AIDS patients, is effective in inhibiting the viral replication of Sars-Cov-2, the virus that causes COVID-19. Studies by the Oswaldo Cruz Foundation (Fiocruz), the largest medical research center in Latin America and linked to the Brazilian Ministry of Health, found that Atazanavir is capable of slowing down the multiplication of the virus and that it also reduces the inflammatory process in the lungs. of patients who get it. The drug “reduced the production of proteins that are linked to the inflammatory process in the lungs and, therefore, prevented the worsening of the clinical picture generated by the disease,” Fiocruz said in a statement.


Surge of Coronavirus Testing Creates Confusion in America

Blood tests to detect COVID-19 may play a key role in decide whether millions of Americans can safely return to work or reopen schoolsBut public health officials have warned that the current wave of unregulated testing is creating such confusion that it could ultimately slow the road to recovery.

According to the United States regulatory authorities, more than 70 companies have signed up in recent weeks to sell so-called antibody tests. Governments around the world hope that rapid tests, which generally use a puncture to deposit a drop of blood on a test strip, could lessen current social restrictions by identifying people who have already contracted the virus and who may have developed certain immunity to it.

But some key questions remain to be answered: How accurate are the tests? How much protection is needed? How long will that protection last?

Blood tests are different from tests based on nasal samples that are currently used to diagnose active COVID-19 infections. Instead, rapid tests are based on detecting proteins in the blood called antibodies, which the body produces days or weeks after getting an infection. The same approach is used for HIV, hepatitis, Lyme disease, lupus, and many other conditions.

For many infections, antibody levels that are above a specific threshold indicate that the person’s immune system has successfully fought off the virus and is likely protected against reinfection. For COVID-19, it is still unclear what level of antibodies makes patients immune or how long that immunity will last.

Due to the relative simplicity of rapid test technology, the Food and Drug Administration (FDA) decided to remove the initial revision of antibody tests as part of its emergency response to the outbreak of the new coronavirus.

Today, the tests are most helpful to researchers studying how the virus has spread through the American population. The government said Friday that it has started using rapid tests to screen 10,000 volunteers. The White House has not detailed a broader plan for the tests and how those results could be used.

With almost no oversight by the FDA, “it really has created a mess that is going to take time to clean up,” said Eric Blank of the Association of Laboratories for Public Health. “In the meantime, we have a lot of companies marketing a lot of things and nobody has any idea how good it is,” he added.

It also reads:

Members of Blank’s group, which represents state and local laboratory officials, have asked the FDA to rethink its approach to testing. That approach allows companies to launch a test as long as they notify the agency and include legal notices. Companies must clarify that their tests have not been approved by the FDA and that they cannot rule out whether someone is truly infected.

Last week, FDA Commissioner Stephen Hahn said in a statement that the agency will take “appropriate action” against companies that make false claims or sell inaccurate evidence.

Physician Allison Rakeman of the New York City Public Health Laboratories said some local hospitals are assuming that the tests, which are listed on the FDA website, “have been approved, which has not happened.”

The danger with faulty testing is that people will mistakenly conclude that they are immune or that they are no longer spreading the virus, Rakeman said. “Then someone will go home and kiss their 90-year-old grandmother,” he added. “You don’t have to give someone a false sense of security.”

In most people, the new coronavirus causes mild or moderate symptoms, such as fever and cough that disappears within two to three weeks, but in some cases, especially among older adults and people with pre-existing conditions, it can cause more serious conditions, like pneumonia and death.

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Despite his success in killing laboratory corona .. FDA warns against parasite drug Ivermectin veterinary

The US Food and Drug Administration (FDA) has warned people against using animal-based parasite Ivermectin as a treatment for COVID-19, after the announcement of a study led by the Australian University of Monash, showing that the drug prevents the reproduction of the virus in a laboratory environment.

An article for Antiviral Research describes how the coronavirus causing COVID-19 – Ivermectin When performing laboratory tests on it, but the drug was not given to people or animals in this study.

Antivirals and corona
Antivirals and corona

In a letter posted on its website, the US Food and Drug Administration said that more testing is needed to determine whether ivermectin may be safe or effective in preventing or treating COVID-19 when tested in animals or humans.

“The U.S. Food and Drug Administration is concerned with the health of consumers who may take medications from themselves by consuming ivermectin products for animals, believing that they can be a substitute for ivermectin for humans,” wrote Dr. Stephen Solomon, director of the FDA’s Veterinary Center.

He added: “People should never take animal medication, because the Food and Drug Administration has only assessed their safety and efficacy in the specific animal species for which they were classified, because these animal medications can cause serious harm to people.”

Scanned image from the FDA warning
Scanned image from the FDA warning

Dr. Suleiman added that people should not take any Ivermectin anti-parasite drug, unless it is obtained from a legitimate source or has been prescribed to them by a licensed healthcare provider.

Ivermectin tablets have been approved to treat some parasitic worms in humans and external parasites such as head lice and skin conditions such as rosacea, and the drug has been approved to prevent heartworm disease in some types of small animals and to treat some internal and external parasites in different animals.

The Food and Drug Administration (FDA) warns about any products that are declared to treat COVID-19 before they are officially approved and that their use in humans is authorized by trusted authorities, because what is currently being done is still under testing.


FDA approves first generic albuterol drug for bronchospasm

The first generic drug Proventil HFA (Albuterol Sulfate) metered-dose inhaler, 90 mcg / inhalation, is approved by the Food and Drug Administration (FDA) for the treatment or prevention of bronchospasm in four-year-old patients or older who have reversible obstructive airway disease as well as exercise-induced bronchospasms in this age group.

“The FDA acknowledges the increased demand for albuterol products during the new coronavirus pandemic,” said FDA Commissioner Dr. Stephen M. Hahn. “We are deeply committed to facilitating access to medical products to help address the critical needs of the American public,” added the doctor.

According to the National Heart, Lung, and Blood Institute, bronchospasms occur when the muscles around the airways swell and harden, tightening the airways, making them narrower. Exercise and other physical activities can cause symptoms in most people who have asthma, and this can occur during or immediately after being active. Asthma causes recurrent episodes of wheezing (a wheezing sound when breathing), chest tightness, shortness of breath, and cough. The cough worsens at night or early in the morning. Asthma affects people of all ages, but it often begins during childhood. In the United States, more than 26 million people are known to have asthma, and about 7 million of these are children.

The most common side effects associated with Albuterol Sulfate Metered-Dose Inhaler, 90 mcg / Inhalation, are upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate (tachycardia), tremor, and nervousness.

The FDA regularly takes steps to help guide the industry through the development process for generic products, including complex combination products, such as metered-dose inhalers, which consist of a medication and a device. The development of many generic combination products may be more difficult than that of oral solid forms, such as tablets.

Under the Generic Drug User Fee Modifications (GDUFA), individual companies may collaborate with the FDA as part of its New Drug Abbreviated Forms (ANDA) program. to assist in the development of such complex generic pharmaceuticals. The FDA also publishes guidance documents that describe the FDA recommended steps that companies must follow to submit complete applications for generic pharmaceuticals.

In March 2020, the FDA released a revised draft of a specific product guide for proposed generic albuterol sulfate metered-dose inhalers including pharmaceuticals that reference Proventil HFA. Among other things, the draft guide provides bioequivalence recommendations.

The FDA requires applicants to submit adequate information and data to demonstrate that the complex generic drug-device meets the agency’s rigorous approval standards. These standards ensure high-quality generic pharmaceuticals that are as safe and effective as equivalent brand name drugs.

The FDA granted approval of this generic albuterol sulfate inhalation spray to Cipla Limited.


FDA Calls for Heartburn Drug Zantac to be Recalled Immediately

(CNN) – The US Food and Drug Administration (FDA) Requests Manufacturers Recall All Prescription, Over-The-Counter Ranitidine Drugs Known For The Brand Immediately Zantac, the agency announced Wednesday.

READ: CVS Recalls Zantac and Similar Heartburn Medications Over Cancer Concerns

The FDA noted that an ongoing investigation found that levels of a contaminant in heartburn medications increase over time and, when stored at higher-than-normal temperatures, pose a public health risk.

The pollutant, N-nitrosodimethylamine or NDMA, it is a probable human carcinogen and the FDA has been investigating its ranitidine levels since the summer of 2019.

“We did not see unacceptable levels of NDMA in many of the samples we tested,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in Wednesday’s announcement.

READ: Stop distribution of ranitidine medications for heartburn (found contaminants)

“However, since we do not know how or for how long the product could have been stored, we decided that it should not be available to consumers and patients unless its quality can be guaranteed,” Woodcock said. “The FDA will continue our efforts to ensure that impurities in other medications do not exceed acceptable limits so that patients can continue to take medications without concern.”

According to the FDA announcement, letters are now being sent to all ranitidine manufacturers requesting that they withdraw the products from the market, and consumers are advised to stop taking the current ranitidine tablets or liquid medications. The FDA requests that they be disposed of properly and no longer be purchased.

READ: Heartburn Drugs May Cause Allergies, Study Says

Due to the pandemic of coronavirus, the FDA stated that drugs should not be brought to a “drug drop-off location,” but follow the disposal instructions in the medication guide or package insert, or follow the safe disposal steps recommended by the FDA on their website.

Consumers who want to continue treating their condition should consider using other approved medications, according to the FDA.

To date, the FDA has not found NDMA in other products, such as famotidine or Pepcid, esomeprazole or Nexium, or omeprazole or Prilosec.

For patients taking prescription ranitidine, the FDA said they should discuss other treatment options with their doctor before stopping the medication.

“There are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA,” according to the FDA.

In September CVS Pharmacy, Walgreens and Walmart announced that they would no longer sell Zantac and other over-the-counter ranitidine drugs due to concerns that they might contain NDMA.

Then, in October, the drug maker Sanofi voluntarily recalled the Zantac OTC sold in U.S and Canada. At the time, the company said it issued the recall “due to inconsistencies in the preliminary test results.”


FDA orders Zantac drug to be recalled immediately

The Federal Food and Drug Administration (FDA) ordered Wednesday the drug to control heartburn Zantac withdraw from the market immediately after finding a contamination problem in the products.

This determination applies to all versions of the ranitidine brand that can be purchased by prescription and over-the-counter. Medications are used to treat stomach acid and ulcers.

Patients should stop taking any of the medications they currently have and discard them, the FDA said.

Last year the federal agency had indicated that patients could continue taking the medications and that they were facing no health risks from contamination with a cancer-causing chemical found in various brands.

However, many companies chose not to sell the product.


US gives limited authorization of antimalarial drugs to treat coronavirus

The United States Medicines Regulatory Authority (Fda) authorized the limited emergency use of two antimalarial drugs, which the President of U.S has promoted to treat the coronavirus.

In a statement released Sunday, the U.S. Department of Health and Human Services detailed recent donations of medicine to a national stockpile, including the chloroquine and hydroxychloroquine, both investigated as potential treatments for COVID-19.

The document says the FDA allowed “adolescent and adult hospitalized patients with COVID-19 to be distributed and prescribed by physicians, appropriately, when a clinical trial is not available or is not feasible

Trump said last week that two drugs could be a “gift from God,” although scientists warned against the dangers of exaggerating unproven treatments.

Several researchers including Anthony Fauci, The leading infectious disease expert, the public has been asked to be cautious until clinical trials validate more detailed studies.

Two United States medical agencies, the National Institutes of Health and the Advanced Biomedical Research and Development Authority, are working on clinical trials.

Some in the scientific community fear that Trump’s endorsement of the drugs could create shortages for patients who need them to treat lupus and rheumatoid arthritis, diseases for which they are approved.

U.S has registered more than 140 thousand new cases of coronavirus and two thousand 489 deaths, according to a count by Johns Hopkins University.