FDA Revokes Emergency Coronavirus Use of Malaria Drugs - The New York Times

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The Food and Drug Administration said on Monday that it was revoking emergency authorization of two malaria drugs to treat Covid-19 in hospitalized patients, saying that they are “unlikely to be effective” and could carry potential risks.

The drugs, hydroxychloroquine and chloroquine, were heavily promoted by President Trump after a handful of small, poorly controlled studies suggested that they could work against the disease caused by the coronavirus. Mr. Trump said he took hydroxychloroquine after he had been exposed to two people who tested positive for the coronavirus.

The agency said that after reviewing some data, it determined that the drugs, particularly hydroxychloroquine, did not demonstrate potential benefits that outweighed their risks. Earlier this spring, the F.D.A. had also issued a warning that the drugs could cause dangerous heart arrhythmias in Covid-19 patients.

The review that led to the revocation found more than 100 cases of serious heart disorders in Covid-19 patients taking the drugs, including 25 that were fatal. Other problems were linked to the drugs as well.

Lawmakers and some public health experts have criticized the Trump administration for politicizing the government’s medical and science arms during the pandemic, and of pressuring agencies like the F.D.A. to relax its standards for drugs and medical devices, to get them on the market faster.

“The F.D.A. withdrew an emergency use authorization that never should have been issued in the first place,” Senator Ron Wyden, Democrat of Oregon, said in a statement. “By ignoring science and caving to political pressure from the White House, the F.D.A. stoked false hope and put American lives in danger, while damaging the agency’s reputation in the process.”

On Monday, Mr. Trump stood by his support of the drugs, saying at a White House round table, “All I know is that we’ve had some tremendous reports.” He added: “It certainly didn’t hurt me. I feel good.”

Dr. Peter Lurie, the president of the Center for Science in the Public Interest, said the F.D.A.’s move showed “how, in the end, science can triumph over celebrity and unscientific pronouncements from the White House. In the end, the truth comes out.”

Dr. Lurie said that while some clinical trials of hydroxychloroquine were still underway, so far the evidence “keeps going in the same direction” — that the drug is not effective to treat Covid-19.

In March, the F.D.A. authorized hospitals to use stockpiles of the drugs, which pharmaceutical companies had donated, to treat patients with the virus. Doctors have always been able to prescribe the drugs to individual patients as they see fit.

But in a letter on Monday revoking the authorization, the agency said that further studies had shown that the two drugs were unlikely to be effective in stopping the virus, and that national treatment guidelines didn’t recommend using them outside of clinical trials.

According to the letter, written by Denise M. Hinton, the F.D.A.’s chief scientist, the request to revoke the authorization came from the Biomedical Advanced Research and Development Authority, the unit of the Department of Health and Human Services that had initially asked for the authorization.

In April, the head of that unit, Dr. Rick Bright, said he was removed from his post after he pushed for rigorous vetting of hydroxychloroquine, even as Mr. Trump and his allies were enthusiastically promoting it.

The use of hydroxychloroquine spiked after Mr. Trump continuously praised its potential, calling it a possible “game changer” and saying, “What the hell do you have to lose?” His repeated promotions during daily briefings at the White House prompted runs on pharmacies, threatening supplies for the drugs, which are also taken by people with rheumatoid arthritis and lupus.

Alex M. Azar II, the secretary of health and human services, said at the round table Monday that the F.D.A.’s action only ended the authorization for hospitals to use federal stockpiles of the drugs on hospitalized patients and noted that doctors could still prescribe the drugs to patients.

“In fact the F.D.A. removal of the emergency use authorization takes away what had been a significant misunderstanding by many that had made people think it could only be used in a hospital setting,” he said.

Interest in hydroxychloroquine has waned in recent weeks as further studies showed that the drug did not appear to be effective in treating or preventing Covid-19. Earlier this month, a study of 821 people who had been exposed to patients infected with the virus showed that the drug did not prevent infection.

In May, an article in The Lancet about another study concluded that hydroxychloroquine and chloroquine did not help patients and might have harmed them — but that study was later retracted after the authors could not verify the database of medical records on which the article was based.

As of May 6, there were 347 adverse events in Covid-19 patients taking hydroxychloroquine, and 38 in those taking chloroquine (which is used less often), the F.D.A. said, based on a search of its own database and reports to poison-control centers. The majority of cases, 69 percent, involved men with a median age in the early 60s.

The total included 109 serious heart problems, including 80 cases of a serious heart rhythm disorder called QT prolongation. Other patients had different rhythm abnormalities. Over all, 25 of the 109 died. Many who had cardiac effects had been given other drugs at the same time, like the antibiotic azithromycin, that can also cause QT prolongation.

There were also serious adverse events not affecting the heart in 113 cases, including liver abnormalities, which are listed on the drugs’ labeling as a possible problem. Some patients had severe kidney problems, but renal disease has been linked to the coronavirus itself.

Four patients developed a blood disorder called methemoglobinemia, and two died. That condition is not mentioned in the drugs’ labeling, but had been known as a rare side effect of some medications.

The Coronavirus Outbreak

• Frequently Asked Questions and Advice

  Updated June 12, 2020

  • Does asymptomatic transmission of Covid-19 happen?

    So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.

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    Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.

  • How does blood type influence coronavirus?

    A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.

  • How many people have lost their jobs due to coronavirus in the U.S.?

    The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.

  • Will protests set off a second viral wave of coronavirus?

    Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.

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    Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.

  • My state is reopening. Is it safe to go out?

    States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.

  • What are the symptoms of coronavirus?

    Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.

  • How can I protect myself while flying?

    If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)

  • How do I take my temperature?

    Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.

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    The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.

  • What should I do if I feel sick?

    If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.

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    If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.

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It was not possible to calculate rates of the adverse events, because the total number of patients given the drugs was not known, the F.D.A. said.

The agency also issued a warning Monday about combining hydroxychloroquine or chloroquine with remdesivir, a recently authorized treatment for patients with Covid-19. The F.DA. said the malaria drugs could interfere with remdesivir’s ability to fight the virus.

Several trials of hydroxychloroquine are still underway, including additional studies of whether it can be used to prevent coronavirus infection. The World Health Organization resumed a study of the drug after briefly halting it in the wake of the Lancet article.

Two arms of the National Institutes of Health — the National Heart, Lung and Blood Institute and the National Institute for Allergy and Infectious Diseases — are conducting clinical trials of hydroxychloroquine. Dr. Francis Collins, the N.I.H. director, said those studies would continue.

“I think that would be unfortunate not to,” Dr. Collins said. “What’s been missing here are really well-designed, randomized placebo-controlled trials for hospitalized patients.”

Hydroxychloroquine is still being embraced elsewhere, including in Brazil, which is battling an explosive outbreak.

Members of Congress have questioned increases in the F.D.A.’s granting of emergency use authorizations during the pandemic for certain drugs as potential treatments. They have also questioned authorizations for antibody and diagnostic tests whose data had not been thoroughly vetted before approval, and for certain types of masks and other devices.

Some Democratic lawmakers have criticized the Trump administration for pressuring the agency into issuing too many emergency approvals.

In some cases, the F.D.A. has recently rescinded emergency approvals for use or reuse of some masks and told companies that did not meet a deadline for submitting data on antibody tests that they should not be selling them. The Government Accountability Office recently testified that it planned to look into the F.D.A.’s emergency authorizations.

On Monday, Democrats framed the news as further evidence that Mr. Trump cannot be relied upon in the coronavirus pandemic. Senator Chuck Schumer, the minority leader from New York, said on Twitter, “On medical issues like on so much else, he doesn’t know what he is talking about.”

Denise Grady, Sheryl Stolberg and Michael Crowley contributed reporting.

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