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| F.D.A. Warns of Heart Problems From Malaria Drugs Used for Coronavirus | F.D.A. Warns of Heart Problems From Malaria Drugs Used for Coronavirus |
| (about 5 hours later) | |
| The Food and Drug Administration issued a safety warning on Friday about hydroxychloroquine and chloroquine, malaria drugs that have been promoted by President Trump repeatedly and widely used to treat coronavirus patients despite the lack of evidence that they work. | The Food and Drug Administration issued a safety warning on Friday about hydroxychloroquine and chloroquine, malaria drugs that have been promoted by President Trump repeatedly and widely used to treat coronavirus patients despite the lack of evidence that they work. |
| The drugs can cause dangerous abnormalities in heart rhythm in coronavirus patients, and should be used only in clinical trials or hospitals where patients can be closely monitored for heart problems, the Food and Drug Administration warned in a safety communication issued on Friday. | The drugs can cause dangerous abnormalities in heart rhythm in coronavirus patients, and should be used only in clinical trials or hospitals where patients can be closely monitored for heart problems, the Food and Drug Administration warned in a safety communication issued on Friday. |
| Top health experts have regularly contradicted the president. . This week, a federal official abruptly removed from his post as head of an agency involved in development of a vaccine, complained that he was pressured to endorse these drugs without adequate science. Administration officials said he had been dismissed for other reasons. | Top health experts have regularly contradicted the president. . This week, a federal official abruptly removed from his post as head of an agency involved in development of a vaccine, complained that he was pressured to endorse these drugs without adequate science. Administration officials said he had been dismissed for other reasons. |
| With no vaccine or effective treatment for Covid-19, the disease caused by the coronavirus, many hospitals have been using hydroxychloroquine, sometimes with the antibiotic azithromycin, in the hope that they might help. In recent interviews, doctors around the country have cited their desperate need to help patients and try potential treatments despite limited evidence. | With no vaccine or effective treatment for Covid-19, the disease caused by the coronavirus, many hospitals have been using hydroxychloroquine, sometimes with the antibiotic azithromycin, in the hope that they might help. In recent interviews, doctors around the country have cited their desperate need to help patients and try potential treatments despite limited evidence. |
| Results of small studies have trickled out in the last few weeks that signaled more problems with using the malaria drugs to treat coronavirus patients. The latest report, on Friday in the journal Nature Medicine, describes abnormal heart rhythms in 84 patients treated with the drugs. | Results of small studies have trickled out in the last few weeks that signaled more problems with using the malaria drugs to treat coronavirus patients. The latest report, on Friday in the journal Nature Medicine, describes abnormal heart rhythms in 84 patients treated with the drugs. |
| Several medical societies, including the Infectious Diseases Society of America, the American Thoracic Society and the American College of Cardiology, have warned of the risks of using malaria drugs with azithromycin to treat patients with Covid-19 outside of a clinical trial or without close monitoring. | Several medical societies, including the Infectious Diseases Society of America, the American Thoracic Society and the American College of Cardiology, have warned of the risks of using malaria drugs with azithromycin to treat patients with Covid-19 outside of a clinical trial or without close monitoring. |
| “The F.D.A. is aware of reports of serious heart rhythm problems in patients with Covid-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin” and other drugs that can disrupt heart rhythm, the statement said. It also noted that many people were getting outpatient prescriptions for the drugs in the hopes of preventing the infection or treating it themselves. | “The F.D.A. is aware of reports of serious heart rhythm problems in patients with Covid-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin” and other drugs that can disrupt heart rhythm, the statement said. It also noted that many people were getting outpatient prescriptions for the drugs in the hopes of preventing the infection or treating it themselves. |
| The warning is based on reports from multiple sources that described adverse events, including several types of abnormal heart rhythm, “and in some cases death,” the F.D.A. said. | The warning is based on reports from multiple sources that described adverse events, including several types of abnormal heart rhythm, “and in some cases death,” the F.D.A. said. |
| The message is the second warning about the drugs this week from a federal health agency. On Tuesday, guidelines from the National Institute of Allergy and Infectious Diseases cautioned that patients receiving hydroxychloroquine or chloroquine should be monitored for adverse effects, particularly an abnormality in heart rhythm called prolonged QTc interval. And at a White House briefing that day, the F.D.A. commissioner, Dr. Stephen Hahn, emphasized that the agency wanted data from randomized clinical trials before considering the drugs as a valid treatment. | The message is the second warning about the drugs this week from a federal health agency. On Tuesday, guidelines from the National Institute of Allergy and Infectious Diseases cautioned that patients receiving hydroxychloroquine or chloroquine should be monitored for adverse effects, particularly an abnormality in heart rhythm called prolonged QTc interval. And at a White House briefing that day, the F.D.A. commissioner, Dr. Stephen Hahn, emphasized that the agency wanted data from randomized clinical trials before considering the drugs as a valid treatment. |
| Rick Bright, who led the Biomedical Advanced Research and Development Authority, the agency seeding money to companies working on vaccines, said on Wednesday that he was removed from his post after he pressed for rigorous vetting of hydroxychloroquine, and that the administration had put “politics and cronyism ahead of science.” | Rick Bright, who led the Biomedical Advanced Research and Development Authority, the agency seeding money to companies working on vaccines, said on Wednesday that he was removed from his post after he pressed for rigorous vetting of hydroxychloroquine, and that the administration had put “politics and cronyism ahead of science.” |
| There is no proven treatment for the coronavirus, and there is no proof that hydroxychloroquine and chloroquine can help coronavirus patients. Those two drugs are approved to treat malaria and the autoimmune diseases lupus and rheumatoid arthritis. But earlier reports from France and China suggesting a benefit led to interest in the drugs, even though the reports lacked the scientific controls needed to determine whether the drugs actually worked. The French study was later discredited. | There is no proven treatment for the coronavirus, and there is no proof that hydroxychloroquine and chloroquine can help coronavirus patients. Those two drugs are approved to treat malaria and the autoimmune diseases lupus and rheumatoid arthritis. But earlier reports from France and China suggesting a benefit led to interest in the drugs, even though the reports lacked the scientific controls needed to determine whether the drugs actually worked. The French study was later discredited. |
| Scientists have urged that the drugs be tested in controlled clinical trials to find out definitively whether they can fight the coronavirus or quell overreactions by the immune system that can become life-threatening. Those studies are underway in the United States and around the world. | Scientists have urged that the drugs be tested in controlled clinical trials to find out definitively whether they can fight the coronavirus or quell overreactions by the immune system that can become life-threatening. Those studies are underway in the United States and around the world. |
| Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a member of the president’s coronavirus task force, has not endorsed the drugs, but has consistently said that scientific evidence is essential to find out whether they work. | Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a member of the president’s coronavirus task force, has not endorsed the drugs, but has consistently said that scientific evidence is essential to find out whether they work. |
| “I have been very clear of the importance of doing randomized controlled trials to definitively prove whether something is both safe and effective,” he said in an interview. | “I have been very clear of the importance of doing randomized controlled trials to definitively prove whether something is both safe and effective,” he said in an interview. |
| A report on Friday, from doctors in New York, adds to concerns about combining hydroxychloroquine and azithromycin. In 84 hospitalized patients receiving the drugs, electrocardiograms found a rhythm disruption called a prolonged QTc interval a few days after the treatment began. In nine cases the disorder was severe, reaching levels known to increase the risk of sudden death. None of the patients died from heart problems, however. | A report on Friday, from doctors in New York, adds to concerns about combining hydroxychloroquine and azithromycin. In 84 hospitalized patients receiving the drugs, electrocardiograms found a rhythm disruption called a prolonged QTc interval a few days after the treatment began. In nine cases the disorder was severe, reaching levels known to increase the risk of sudden death. None of the patients died from heart problems, however. |
| Updated June 5, 2020 | Updated June 5, 2020 |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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.) | 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.) |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| Patients given the combination should be carefully monitored, especially if they have other chronic conditions and if they are also receiving other drugs known to affect heart rhythm, the doctors, from NYU Langone Health, said in a letter to the journal Nature Medicine. | Patients given the combination should be carefully monitored, especially if they have other chronic conditions and if they are also receiving other drugs known to affect heart rhythm, the doctors, from NYU Langone Health, said in a letter to the journal Nature Medicine. |
| Many of the 84 patients had other health problems, including 65 percent with high blood pressure and 20 percent with diabetes. Their ages ranged from 18 to 88, with an average of 63, and 74 percent were male. Many hospitals are reporting that the disease appears more serious in men than in women. | Many of the 84 patients had other health problems, including 65 percent with high blood pressure and 20 percent with diabetes. Their ages ranged from 18 to 88, with an average of 63, and 74 percent were male. Many hospitals are reporting that the disease appears more serious in men than in women. |
| The doctors suggested that the underlying illnesses and the severity of the coronavirus infection may have made the patients especially vulnerable to the cardiac effects of the combined drugs. | The doctors suggested that the underlying illnesses and the severity of the coronavirus infection may have made the patients especially vulnerable to the cardiac effects of the combined drugs. |
| Their study was peer reviewed but did not include a comparison group of patients who did not receive the drugs, to see if their heart rhythm changed as the disease progressed. | Their study was peer reviewed but did not include a comparison group of patients who did not receive the drugs, to see if their heart rhythm changed as the disease progressed. |
| Another study, analyzing the records of 368 Veterans Affairs patients, posted on Tuesday but not yet peer-reviewed, found that hydroxychloroquine, with or without azithromycin, did not help patients avoid the need for ventilators. And hydroxychloroquine alone was associated with an increased risk of death. | Another study, analyzing the records of 368 Veterans Affairs patients, posted on Tuesday but not yet peer-reviewed, found that hydroxychloroquine, with or without azithromycin, did not help patients avoid the need for ventilators. And hydroxychloroquine alone was associated with an increased risk of death. |
| But the study was not a controlled trial, was not peer-reviewed and patients who received the drugs were sicker to begin with. The authors wrote, “These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs.” | But the study was not a controlled trial, was not peer-reviewed and patients who received the drugs were sicker to begin with. The authors wrote, “These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs.” |