In January 2020, the World Health Organization (WHO) declared the coronavirus (COVID) from China a global health emergency. Cases of this new infection were first reported in Wuhan, China, in early December 2019. Since then, cases have been reported in several other countries. All cases have been linked to travel to China. The Centers for Disease Control and Prevention (CDC) and WHO are monitoring the situation.
What is COVID-19?
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases, such as MERS (Middle East respiratory syndrome) and SARS (severe acute respiratory syndrome). Coronaviruses are transmitted between animals and people. The new strain is called COVID-19 acute respiratory disease (novel coronavirus), and it had not previously been identified in humans.
The new virus appears to be spreading from person to person. It may be spread by respiratory droplets when someone coughs or sneezes. But it’s unclear exactly how it spreads or how contagious it is. Research is ongoing. This virus is new, so not much is known about it yet.
What are COVID-19 symptoms?
Symptoms of COVID-19 can be mild to severe. Some common signs of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death. A vaccine isn’t currently available.
What can I do to prevent the spread of infection?
The W.H.O. and C.D.C. recommend that you take the usual precautions to help prevent the spread of respiratory viruses:
Wash your hands often with soap and water or use an alcohol-based hand sanitizer.
Cover your mouth and nose with your elbow or tissue when you cough or sneeze.
Avoid touching your eyes, nose and mouth if your hands aren’t clean.
Avoid close contact with anyone who is sick.
Clean surfaces that you touch often.
Stay home from work, school and public areas if you’re sick.
Check with your health care provider if you have a fever, cough and difficulty breathing, and tell him or her about any recent travel.
Avoid eating raw meat or animal organs.
If you’re visiting live markets in areas that have recently had cases of the new coronavirus, avoid contact with live animals and surfaces they may have touched.
for the Lung Injury Response Mortality Working Group*
Abstract
BACKGROUND
As of January 7, 2020, a total of 2558 hospitalized patients with nonfatal cases and 60 patients with fatal cases of e-cigarette, or vaping, product use–associated lung injury (EVALI) had been reported to the Centers for Disease Control and Prevention (CDC).
METHODS
In a national study, we compared the characteristics of patients with fatal cases of EVALI with those of patients with nonfatal cases to improve the ability of clinicians to identify patients at increased risk for death from the condition. Health departments reported cases of EVALI to the CDC and included, when available, data from medical-record abstractions and patient interviews. Analyses included all the patients with fatal or nonfatal cases of EVALI that were reported to the CDC as of January 7, 2020. We also present three case reports of patients who died from EVALI to illustrate the clinical characteristics common among such patients.
RESULTS
Most of the patients with fatal or nonfatal cases of EVALI were male (32 of 60 [53%] and 1666 of 2498 [67%], respectively). The proportion of patients with fatal or nonfatal cases was higher among those who were non-Hispanic white (39 of 49 [80%] and 1104 of 1818 [61%], respectively) than among those in other race or ethnic groups. The proportion of patients with fatal cases was higher among those 35 years of age or older (44 of 60 [73%]) than among those younger than 35 years, but the proportion with nonfatal cases was lower among those 35 years of age or older (551 of 2514 [22%]). Among the patients who had an available medical history, a higher proportion of those with fatal cases than those with nonfatal cases had a history of asthma (13 of 57 [23%] vs. 102 of 1297 [8%]), cardiac disease (26 of 55 [47%] vs. 115 of 1169 [10%]), or a mental health condition (32 of 49 [65%] vs. 575 of 1398 [41%]). A total of 26 of 50 patients (52%) with fatal cases had obesity. Half the patients with fatal cases (25 of 54 [46%]) were seen in an outpatient setting before hospitalization or death.
CONCLUSIONS
Chronic conditions, including cardiac and respiratory diseases and mental health conditions, were common among hospitalized patients with EVALI.
E-cigarette, or vaping, products were introduced into the U.S. market in 2007, and after their introduction, sales rose rapidly.1 The aerosols generated by these products typically contain nicotine, flavorings, and additives2 and can deliver other substances, such as tetrahydrocannabinol (THC), the main psychoactive component in cannabis, and cannabidiol.3,4 Because solvents and other constituents generally differ between nicotine- and THC-containing products,5 dual users of nicotine and THC are potentially exposed to a greater variety of constituents. Few regulations exist to control the quality and composition of the ingredients used in e-cigarettes and e-liquids, including solvents.6
Since August 2019, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration, state and local health departments, and others have been investigating a national outbreak of e-cigarette, or vaping, product use–associated lung injury (EVALI).7 Most of the patients with EVALI reported using THC-containing products and were hospitalized; many received critical care and respiratory support.8,9 Vitamin E acetate, an additive sometimes used in THC-containing products,10 is strongly linked to the EVALI outbreak; however, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC-containing or non–THC-containing products.11
The clinical presentations and outcomes of survivors of EVALI have been described,8,12-18 but data from patients who died are limited. Moritz et al. reported that the median age of the patients who survived EVALI was 23 years, as compared with 45 years among those who died.13National studies are lacking to describe in detail the demographic and clinical characteristics and substance use history of patients with fatal cases of EVALI or to compare such data with data from patients with nonfatal cases. We conducted a national study to compare e-cigarette, or vaping, product use, medical history, and clinical course between patients with fatal cases of EVALI and those who were hospitalized for the condition but survived in order to improve the ability of clinicians to recognize the clinical characteristics that may be associated with an increased risk of death. We also present three case reports of patients who died from EVALI to illustrate the clinical characteristics common among such patients.
Methods
STUDY OVERSIGHT
This investigation was reviewed in accordance with CDC procedures for protection of human research participants and was considered nonresearch public health surveillance activity intended for use in disease control or to inform policy during an emergency response. Details regarding the author contributions to the study are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.
CASE DEFINITIONS
State health departments, a Council of State and Territorial Epidemiologists Task Force, and the CDC developed and disseminated EVALI surveillance case definitions and data-collection tools beginning in August 2019.7,19,20 For this analysis, a fatal case of EVALI was defined as a confirmed or probable12 case of EVALI (as determined with the use of the primary or out-of-hospital case definitions shown in Tables S1 and S2 in the Supplementary Appendix) in a patient who died as of January 4, 2020, and whose death was reported to the CDC as of January 7, 2020. A nonfatal case of EVALI was defined as a confirmed or probable case of EVALI in a hospitalized patient who had not died and whose case was reported to the CDC as of January 7, 2020.
DATA COLLECTION
Health departments from 50 states, the District of Columbia, and two U.S. territories (Puerto Rico and the Virgin Islands) voluntarily reported cases of EVALI in hospitalized patients to the CDC and, when available, included data from medical-record abstractions and patient interviews. Proxies were interviewed if patients were too ill or had died. The CDC received data on patients hospitalized for EVALI through a standardized national case-report form. Medical records were the primary data source for the variables included in the standardized form for both fatal and nonfatal cases; patient interviews were used for nonfatal cases and proxy interviews for fatal cases when data from the medical-record abstraction were missing. Individual state health authorities determined the methods and procedures used for data collection (such as those to be used for the incorporation of data from proxy interviews), which resulted in variations in data completeness. Data on fatal cases were supplemented with data abstracted from medical-record review, which included additional variables such as body-mass index and initial vital signs and laboratory results that were not available for nonfatal cases. Imaging reports were reviewed by two investigators.
ANALYSES
The results of the descriptive analyses are presented as proportions for categorical variables and medians and ranges for continuous variables. Differences are not reported with P values or confidence intervals because this study describes the entire population of patients with fatal or nonfatal cases of EVALI reported as of January 7, 2020. Analyses were completed with the use of SAS software, version 9.4 (SAS Institute).
Results
RESULTS OF THE NATIONAL STUDY
Table 1.Case Status, Demographic Characteristics, and Substance Use History of Patients with Fatal or Nonfatal Cases of EVALI.
As of January 7, 2020, a total of 2558 nonfatal cases of EVALI in hospitalized patients from 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands and 60 fatal cases in patients from 27 states and the District of Columbia were reported to the CDC. The demographic characteristics and substance use histories of these patients are provided in Table 1. Among the patients with available data on sex, 32 of 60 (53%) of those with fatal cases and 1666 of 2498 (67%) of those with nonfatal cases were male. The median age was 51 years (range, 15 to 75) among patients with fatal cases and 24 years (range, 13 to 85) among those with nonfatal cases. Among the patients with available data on race and ethnic group, 39 of 49 (80%) of those with fatal cases and 1104 of 1818 (61%) of those with nonfatal cases were non-Hispanic white.
Among the patients with available data on e-cigarette, or vaping, product use (45 patients with fatal cases and 2021 with nonfatal cases), 30 (67%) and 1593 (79%), respectively, reported nonexclusive use of THC-containing products; 25 (56%) and 1109 (55%), respectively, reported nonexclusive use of nicotine-containing products; 12 (27%) and 803 (40%), respectively, reported using both THC-containing and nicotine-containing products; and 2 (4%) and 122 (6%), respectively, reported using neither (Table 1). Among the patients with available data on combustible tobacco use, 44 of 56 (79%) of those with fatal cases and 439 of 1327 (33%) of those with nonfatal cases were current or former smokers.
Table 2.Medical and Mental Health Conditions in Fatal or Nonfatal Cases of EVALI.
The medical histories of the patients with fatal or nonfatal cases of EVALI who had available data are provided in Table 2. The patients with fatal cases were more likely than those with nonfatal cases to have a history of any respiratory disease (25 of 57 [44%] vs. 371 of 1429 [26%]), cardiac disease (26 of 55 [47%] vs. 115 of 1169 [10%]), and any mental health condition (32 of 49 [65%] vs. 575 of 1398 [41%]). A total of 26 of 50 patients (52%) with fatal cases had obesity.
Table 3.Clinical Course, Initial Vital Signs, and Initial Laboratory Results in Hospitalized Patients with Fatal or Nonfatal Cases of EVALI.
The clinical characteristics of the hospitalized patients with fatal or nonfatal cases of EVALI who had available data are provided in Table 3 (full details are provided in Table S3). Approximately half the hospitalized patients with fatal cases (25 of 54 [46%]) and 479 of 2320 (21%) of those with nonfatal cases had presented initially in an outpatient setting (e.g., primary care physician location, urgent care center, or emergency department) without being admitted for EVALI-related symptoms. Among the hospitalized patients with fatal cases, 40 of 55 (73%) had hypoxia, 25 of 54 (46%) had tachycardia, and 26 of 52 (50%) had tachypnea at the time of admission to the hospital. The laboratory values at the initial admission showed that 37 of 52 patients (71%) with fatal cases had leukocytosis (white-cell counts >11,000 per cubic millimeter) and 29 of 45 (64%) had neutrophil predominance (white-cell count with >80% neutrophils). Most of the patients with fatal cases (93%) died in the hospital. Radiologic findings are provided in Table S4.
CASE REPORTS OF THREE PATIENTS WHO DIED FROM EVALI
Case 1: Multiple Preexisting Medical Conditions
A patient with coexisting asthma, chronic obstructive pulmonary disease, morbid obesity, preexisting heart failure, and reported use of THC-, cannabidiol-, and nicotine-containing e-cigarette, or vaping, products was admitted to the hospital 8 days after the onset of symptoms because of severe respiratory distress. Treatment with broad-spectrum antibiotics, diuretics, bronchodilators, systemic glucocorticoids, and bilevel positive airway pressure was initiated. Within 48 hours, acute respiratory distress syndrome developed, and the patient underwent intubation and mechanical ventilation. Evaluation and treatment decisions were complicated by respiratory failure and multiple chronic conditions. The provision of adequate oxygenation and ventilation remained difficult even though the patient was in a prone position. The patient died on hospital day 21. The full case report is provided in the Supplementary Appendix.
Case 2: Recrudescence of Symptoms
A patient visited two different health facilities 2 days after the onset of illness and was discharged home with a prescription for antibiotics and antiemetics for presumed community-acquired pneumonia. Three days later, the patient visited a different health facility and was admitted; treatments with bronchodilators and broad-spectrum antibiotics were initiated. The patient reported using nicotine-containing, but not THC-containing, e-cigarette, or vaping, products. The patient had increasing respiratory distress and fever (to a temperature of 38.9°C), which led to the initiation of systemic glucocorticoids on hospital day 3. On hospital day 5, the patient was discharged home with prescriptions for levofloxacin and a glucocorticoid on a tapering schedule.
Two days after discharge, the patient’s family reported that nausea, vomiting, and malaise recurred, and they found the patient to be unresponsive. Despite resuscitation efforts and readmission, the patient died a few hours later. According to the family report, the patient had used THC-containing products (Dank Vapes and Maui Wowi). Residue on the product cartridges tested positive for THC and vitamin E acetate. The full case report is provided in the Supplementary Appendix.
Case 3: No Glucocorticoids during Initial Hospitalization
A patient visited an outpatient facility the day after the onset of symptoms and was treated for viral gastroenteritis and sent home. This patient presented again with headache, nausea, vomiting, and diarrhea on day 6 of illness and was admitted to the hospital for dehydration. A chest radiograph on hospital day 4 showed prominent bilateral interstitial markings. The patient reported using nicotine-containing e-cigarette, or vaping, products, received treatment with azithromycin, and was transferred to the intensive care unit because of respiratory distress.
On hospital day 15, the patient was discharged home with instructions to abstain from using such products. During an interview with public health department staff, the patient reported having used the THC-containing product Dank Vapes. On day 24, because of continued respiratory compromise, the patient was readmitted to the hospital to undergo intubation and mechanical ventilation. Treatment with systemic glucocorticoids was initiated. On day 40, the patient underwent extracorporeal membrane oxygenation. On day 41, the patient had severe hypotension and cardiac arrest and died. The products submitted for testing after death included a THC-containing product, which was found to contain castor oil (no vitamin E acetate). The full case report is provided in the Supplementary Appendix.
Discussion
This study assesses the clinical characteristics of hospitalized patients with fatal or nonfatal cases of EVALI. Consistent with the findings in previous reports,12,13,15,17 most of the patients with fatal cases reported using THC-containing e-cigarette, or vaping, products. Nearly one third of the patients with fatal cases reported nicotine use only, and almost one quarter reported dual use, which suggests that other causal mechanisms may need to be considered. The median age was higher among the patients with fatal cases than among those with nonfatal cases, and the proportion of patients who had chronic medical conditions or were current or former combustible tobacco smokers was higher among those with fatal cases. Some patients with fatal cases had initially reported gastrointestinal symptoms (e.g., diarrhea and nausea), although such symptoms were reported more frequently among patients with nonfatal cases. Clinicians should consider EVALI in patients who present primarily with constitutional symptoms, gastrointestinal symptoms, or both.21
More than half the patients with fatal cases (63%) received a diagnosis of acute respiratory distress syndrome, which can lead to life-threatening acute hypoxemic respiratory failure.22Patients with EVALI who have multiple chronic conditions may be at higher risk for acute respiratory distress syndrome and its complications. Because traditional mechanical ventilation can worsen lung injury in patients with acute lung injury or acute respiratory distress syndrome, which would then increase the risk of nonpulmonary organ or system failure,23 clinicians should consider evidence-based principles regarding the management of acute respiratory distress syndrome when treating patients with severe cases of EVALI.24
A higher proportion of hospitalized patients with fatal cases than those with nonfatal cases had cardiac disease, asthma, or chronic obstructive pulmonary disease. Cardiac or respiratory conditions in patients who use e-cigarette, or vaping, products may complicate assessment, radiologic interpretations, and management, particularly if the exposure history is incomplete. Patients may withhold medically relevant information because they fear being judged negatively by their clinical provider, they do not want to hear how harmful their behavior was, or they are embarrassed.25 Cases 2 and 3 show how incomplete exposure history may delay treatment. Illegality of THC use can contribute to an incomplete exposure history, which reinforces the need for empathetic, nonjudgmental communication between the clinician and patient (or proxy) in a confidential setting.
Two thirds of patients with fatal cases (65%) had a known mental health condition — a higher percentage than that among patients with nonfatal cases (41%) and the U.S. general population (19%).26 Patients, particularly former smokers, with mental health conditions are more likely to report lifetime and current e-cigarette, or vaping, product use.27 The prevalence of mental health conditions is higher among persons reporting concurrent use of cannabis and conventional cigarettes.28 Addressing underlying mental health conditions among patients with EVALI is an important component of hospital care, discharge planning, and postdischarge follow-up care.29
In the current study, the percentage of patients who had obesity was higher among those with fatal cases (52%) than in the general population (40%). Data on body weight were not available for the patients with nonfatal cases. Obesity, a major risk factor for respiratory diseases,30-33can lead to changes in pulmonary physiologic variables, complicate respiratory disease, and present challenges in achieving adequate mechanical ventilation.30-32,34 More studies are warranted to determine if there is an association between obesity and development of EVALI and whether obesity contributes to the severity of EVALI outcomes.
In outpatient settings, when symptoms are attributable to infections, glucocorticoid use is cautioned9; limited research suggests that glucocorticoids may be beneficial in the treatment of EVALI.8,15,29,35 Glucocorticoid administration may be warranted in severely ill patients when it is considered safe and feasible, after ruling out any life-threatening infections, such as influenza. Among the patients with fatal cases who had available data, the time from the onset of symptoms to glucocorticoid administration varied widely, and coadministration with antibiotics was frequently observed. Few patients with fatal cases had reported improvement with glucocorticoids; administering glucocorticoids too late in the clinical course may partially explain this finding. Glucocorticoid administration has been attributed to rapid clinical improvement, including improvement in oxygenation.21,36 Glucocorticoid administration is recommended if there is no improvement with antibiotics, respiratory support, or both, and the dosing and duration should be determined on a case-by-case basis.36 Current interim clinical guidance from the CDC provides more details on glucocorticoid administration.29
The data in our study have limitations. We counted any patient with EVALI who died as a fatal case, although many patients had preexisting medical conditions that may have contributed to death. Preexisting medical conditions may have influenced hospitalization; however, a previous report noted that as of November 5, 2019, nonhospitalized patients with EVALI were similar to hospitalized patients with EVALI and composed only 5% of all cases.9 If death takes place outside a hospital, it may be difficult to attribute the cause of death to EVALI, so some fatal cases may have been missed. Many patients were either too ill to interview or died before they could be interviewed, so some data are subject to limitations of reporting by proxies. More in-depth data collection and follow-up were used for patients with fatal cases but not for those with nonfatal cases; this could account for some reported differences. We did not compare data on glucocorticoid use between patients with fatal cases and those with nonfatal cases because of limited information from those with nonfatal cases. Misclassification of substance use could have occurred, and ascertainment bias may have been present in the reporting of substance use between the patients with fatal cases and those with nonfatal cases because more proxy interviews were performed for the patients who died.
About half the patients in this series were seen at least once in an outpatient setting before their final hospital admission; earlier diagnosis and appropriate treatment may have improved outcomes.15,35 Eight patients had been discharged from a hospital before they died, which suggests that there may be opportunities to review stability before discharge, to tailor messaging and interventions more toward the avoidance of e-cigarette, or vaping, products, to communicate the importance of adherence to a glucocorticoid-tapering schedule, to enhance coordinated postdischarge care, and to identify worsening symptoms with timely follow-up after discharge.29
Chronic conditions, such as asthma, chronic obstructive pulmonary disease, cardiac disease, and any mental health condition, were common among hospitalized patients with EVALI. Clinicians and public health practitioners should ensure an accurate and timely assessment of exposures and cessation of those exposures.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Drs. Armatas, Byers, Ghinai, Holzbauer, and Navarette and Mr. Clark and Drs. Baldwin, Briss, Jones, King, Krishnasamy, and Rose contributed equally to this article.
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC).
This article was updated on April 23, 2020, at NEJM.org.
We thank Evelyn Twentyman, Rebecca T. Leeb, Mary G. George, Christina Mikosz, and Tara C. Jatlaoui of the CDC, the personnel at the Infectious Diseases Pathology Branch of the CDC, the Lung Injury Response Clinical Task Force, and the Lung Injury Response Epidemiology/Surveillance Task Force.
Author Affiliations
From the National Center for Environmental Health (A.K.W., E.D.M.), the National Center for Chronic Disease Prevention and Health Promotion (E.H.K., S.E., E.E.P., P. Briss, B.A.K.), the National Center on Birth Defects and Developmental Disabilities (K.C.-S., M.L.D.), the Epidemic Intelligence Service, Center for Surveillance, Epidemiology, and Laboratory Services (P.P.S., I.G.), the National Center for Injury Prevention and Control (P.P.S., G.T.B., C.M.J., V.K.), the Center for Preparedness and Response (S.M.H.), the Agency for Toxic Substances and Disease Registry (E.A.K.), and the National Center for Emerging and Zoonotic Infectious Diseases (D.A.R., S.R.-S.), Centers for Disease Control and Prevention, and Emory University School of Medicine (E.A.K.) — all in Atlanta; the California Department of Public Health, Sacramento (C.A.); the Mississippi State Department of Health, Jackson (P. Byers); the Indiana State Department of Health, Indianapolis (C.R.C.); the Illinois Department of Public Health, Springfield (I.G.); the Minnesota Department of Health, St. Paul (S.M.H.); and the New York State Department of Health, Albany (K.A.N.).
Address reprint requests to Dr. Werner at the Centers for Disease Control and Prevention, 4770 Buford Hwy., MS S106-6, Atlanta, GA 30341, or at awerner@cdc.gov.
A complete list of the members of the Lung Injury Response Mortality Working Group is provided in the Supplementary Appendix, available at NEJM.org.
Scott Segal, chairman of anesthesiology at Wake Forest Baptist Health, met Jerome Adams on Feb. 4 when Trump’s surgeon general visited the North Carolina medical facility to discuss HIV in Indiana and the opioid crisis
U.S. Surgeon General Jerome Adams posted a video demonstrating how to make a face covering from a T-shirt. Shortly before the video was posted, the CDC recommended that all Americans wear a such a cloth covering in public settings.
To preserve the supply of N95 and surgical masks for health-care workers treating patients who have contracted COVID-19, the disease caused by the new coronavirus, the CDC has advised all Americans to instead wear (and routinely wash) “cloth face coverings in public settings where other social distancing measures are difficult to maintain.” Examples include grocery stores and pharmacies, the CDC says.
Scott Segal, chairman of anesthesiology at Wake Forest Baptist Health in North Carolina, studies the effectiveness of materials used to make homemade masks.
But some of the materials you can use to make do-it-yourself face masks offer more protection than others. The CDC’s recommendation comes following numerous reports on transmission of COVID-19 from asymptomatic people.
These people don’t have fevers, coughs or runny noses or other common symptoms of COVID-19, and may be unknowingly spreading the virus to others, according to one study published earlier this month, which examined infections of residents of a nursing home in King County, Wash.
Because seemingly healthy people could end up infecting someone, public-health officials are now recommending that all Americans wear a face covering in public, but still advise against buying surgical N95 masks, as they say there is a shortage of these medical-grade masks in hospitals, and they’re needed by health-care workers who are putting their lives on the line.
On Feb. 29, U.S. Surgeon General Jerome Adams said he was against members of the public wearing face masks, and tweeted, “Seriously people- STOP BUYING MASKS! They are NOT effective in preventing general public from catching COVID, but if health-care providers can’t get them to care for sick patients, it puts them and our communities at risk!”
By April 4, Adams changed his stance and released a video on Twitter detailing how to make your own mask. Adams suggested using items you could find around the house like “an old scarf, a bandanna or a hand towel … or an old T-shirt,” to make a mask. He folded the material over several times to make the improvised face mask as nonporous as possible; Adams also added two rubber bands to hang it in place around his ears.
The United States has bungled basically every aspect of its coronavirus response, but one of the most concerning setbacks has been its limited testing. Though the country has tested more than 1.2 million people for the coronavirus as of April 1, the tests came too late for a South Korea–style clampdown on the disease, and they’re still not widespread enough. But even as more and more Americans are finally being checked, a new concern has emerged: The tests seem to have a problematically high false-negative rate, meaning that many people who get tested are receiving a negative test result despite having the virus.
No one is certain exactly how many tests are spitting back false negatives. One preprint paper relying on biological specimens from 213 patients in China suggested a false-negative rate as high as 30 percent. In a New York Times op-ed, Harlan M. Krumholz, director of the Yale New Haven Hospital Center for Outcomes Research and Evaluation, wrote, “Some of my colleagues, experts in laboratory medicine, express concerns the false-negative rate in this country could
be even higher.” Patients have received suspicious results suggesting they don’t have the coronavirus infection despite having symptoms that are completely consistent with what we know about the virus, including high temperatures and a telltale cough. Perhaps the most notable example of a false negative is Li Wenliang, an ophthalmologist in Wuhan, China, who brought COVID-19 to international attention. Li died of the virus, but only after he repeatedly tested negative for the disease.
No test is perfect. The latest rapid influenza test, for example, has a false-negative rate around 20 percent. In the case of COVID-19 testing, some misdiagnoses could come from lab issues. There’s always a degree of error involved in any testing, through some combination of flawed human action and flawed baseline testing. But these days, machines are more capable than ever of calling out and correcting these issues. And the primary test for the novel coronavirus—the RT-PCR, or reverse transcription polymerase chain reaction—is “actually really good,” said Jen Pothof, chief quality officer at UW Health. “So good that if we can capture a single strand of RNA, we can get a result.” The real problem likely lies not in the lab but in the samples doctors are taking from their patients to send in for testing.
Why the coronavirus test gives so many false negatives. 4/11/20, 10(37 AM
https://slate.com/technology/2020/04/coronavirus-testing-false-negatives.html Page 3 of 6
Every virus has its preferred place in its host’s body. But the coronavirus “is a little sneakier than viruses we’ve seen in the past,” said Nam Tran, an associate clinical professor at the University of California, Davis. COVID-19 is primarily a disease of the lungs, but it also hangs out in the nasopharynx, a hard-to-reach cavity halfway between your nose and your throat. The main strategy for testing has been to stick a long swab so deep into people’s noses it actually lands in
the nasopharynx—a process one TikTok user described as akin to “being stabbed in the brain.”
Both Pothof and Tran think that one of the primary reasons RT-PCR tests are getting false negatives is because doctors and nurses aren’t getting all the way into the nasopharynx. Patients may back away in discomfort. And people administering the test may be rushing from patient to patient, so the quality of each individual swab may suffer. When a swab with no COVID-19 on it arrives in the lab, it doesn’t matter how sensitive the RT-PCR is. “If the sample is junk, just to be blunt, you’re not going to find anything,” Tran said.
False negatives may also be a matter of timing. “There’s a misconception if a person has
COVID, the virus is all over the place,” Tran said. “That’s not true.” It mostly concentrates in
the lungs, which is why some doctors have advocated for chest CT scans or lower
respiratory tract specimens as means of testing. It doesn’t appear in the blood, though
eventually people who survive the disease begin to produce antibodies to the virus that
can be detected in a blood sample. And though COVID-19 can be found in the nasopharynx
and even the nasal cavity itself, the concentration of the virus varies over time. Right now,
the test appears to be most effective in patients who have been showing symptoms
(specifically a fever and cough) for three to five days, said Omai Garner, an assistant
professor of pathology and laboratory medicine at UCLA. No one knows how well it
detects the virus in people who are asymptomatic, or how reliable it is after a patient has
begun to recover.
That doesn’t mean the COVID-19 test itself is a failure. But its imperfections do have serious implications for how we manage the pandemic. We need more research to better understand how the coronavirus appears in different parts of the body and at different times throughout the illness. Doctors need better training and information on how to administer the tests, and when. People with serious symptoms who test negative need multiple tests, in order to ensure their diagnosis is certain. And most importantly, patients with symptoms that are consistent with COVID should still behave as though they are infected, no matter what their lab results suggest.
is just as important as wearing them to prevent the spread of COVID-19.
By Vartika Puranik
04/10/2020 05:45am EDT
As we continue our fight against the coronavirus pandemic, the Centers for
Disease Control and Prevention recommend wearing a face mask in public while
shopping for essential items. It is especially advisable for people living in areas
hit hard by the spread of the COVID-19 disease. But there’s one thing many of us
don’t realize: Washing face masks is as important as wearing them.
Ever since the global pandemic hit us, researchers have been studying how long
it can live on various surfaces. A new report published in The Lancet says the
infectious virus could still be present on the outer layer of a mask for up to seven
days.
“Strikingly, a detectable level of the infectious virus could still be present on the
outer layer of a surgical mask on Day Seven,” the researchers wrote. They also concluded that various disinfectants can be used to kill the novel coronavirus to clean the mask properly. We reached out to some experts to find out how to effectively wash face masks.
Is your mask susceptible to the virus?
Homemade masks are definitely susceptible to viruses. Wearing a mask reduces
the concentration of virus particles that can be inhaled from respiratory droplets,
which in turn reduces the transmission of COVID-19, but masks can also carry
the virus.
“Cotton cloth is not designed to fully filter virus particles in the nanometer range. However, it could be very helpful for asymptomatic individuals who would normally be wearing nothing,” said Rodney Rohde, associate dean for research at the College of Health Professions at Texas State University. Dimitar Marinov, assistant professor in the department of hygiene at the Medical University of Varna, told HuffPost that up to 97% of the air’s virus particles can easily penetrate cloth masks. “This is why we advise the use of cloth masks as a method to protect others but not for self-protection,” he added.
How often should we wash our masks? The C.D.C. recommends washing your mask at least once a day. “It should be washed typically when you are done with it,” Rhode said.
Robert Amler, dean of the School of Health Sciences and Practice at New York Medical College and a former C.D.C. chief medical officer, suggested washing your fabric mask after every use. “Avoid touching your face and wash your hands before and after,” he said.
Emily de Golian, a board-certified dermatologist at Dermatology Consultants in
Georgia, told us that, ideally, masks shouldn’t be worn for more than 30 minutes
because the dampness from our breath makes it less effective as a barrier against
coronavirus transmission.
If you’re a frontline worker or spend your time in public where social distancing
measures are difficult to maintain, consider washing your fabric mask every two
hours, if possible, Marinov advised. What’s the best way to wash and dry a fabric face
mask? It is important to note that detergents with bleach-like compounds or other
active ingredients should be used when washing masks. Those kill microbes
more effectively than standard detergents, Rhodes explained.
Machine washing is optimal, and the material of your face mask will determine
the temperature of the water. “Fabric masks can be washed in the warmest
possible water that the fabric will tolerate,” de Golian said. Marinov advised keeping the World Health Organization’s specifications in mind. “The temperature should be at least 60 degrees Celsius [140 degrees Fahrenheit]. We do not have studies on SARS-CoV-2, but the similar SARS-CoV1 dies quickly at temperatures above 60,” he said.
You can also disinfect masks by ironing or putting them in an oven for 20 minutes at about 160 degrees Fahrenheit, Marinov said. If hand washing is your only option, de Golian suggested lathering the masks with soap and scrubbing them for at least 20 seconds with warm to hot water. “Washing should be followed by hot air drying,” Almer said.
Dry your mask on the highest possible heat the fabric will allow. Again, this will
depend on what material was used to construct your mask.
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Everyone deserves accurate information about COVID-19.
An expert committee has concluded that the novel coronavirus is aerosolized
through talking or exhalation, but it’s not yet clear if the viral particles are
viable and emitted in doses sufficient to cause infection.
“While the current SARS-CoV-2 specific research is limited, the results of
News > Medscape Medical News Coronavirus Is Aerosolized Through
Talking, Exhalation, New Report Says Alicia Ault April 04, 2020
Coronavirus Is Aerosolized Through Talking, Exhalation
“…available studies are consistent with aerosolization of virus from normal
breathing,” wrote Harvey Fineberg, MD, PhD, chair of the National Academies
Standing Committee on Emerging Infectious Diseases and 21st Century
Health Threats, in a rapid expert consultation issued April 2. Although aerosolization could be considered a third potential route of transmission — along with large droplets emitted from sneezing or coughing and the transfer of viral particles after touching a contaminated surface — the relative contribution of each mode is uncertain, Fineberg told Medscape Medical News.
Information from Industry Hypothetical case study: Young woman with key symptoms Hypothetical case study: Young woman with key symptoms of narcolepsy of narcolepsy. See video US-NDS-0371(1) It’s also still unclear what it takes to cause infection through aerosolization, he said.
“The best approach without that clear description is all three are possible and we have to guard against all three,” he said. Asked if there is any risk to operating on the assumption that the novel coronavirus can be transmitted through aerosols, Fineberg said, “I see no downside at this time at all.”
But, he said, that assumption does not change what he thinks are the best
precautions in healthcare facilities, which include handwashing and wearing
of personal protective equipment (PPE). Although N95 masks provide the
greatest measure of protection, it’s not realistic to expect that they can be
worn by all personnel, said Fineberg.
“This is a question of prioritization, of risk, and of availability,” he said. In
addition, N95s are difficult to wear for extended periods of time and may not
be necessary in every circumstance, said Fineberg, citing a gradient of risk.
The committee looked into the issue of aerosolization at the request of the
White House Office of Science and Technology Policy (OSTP), Fineberg said.
The report cited several studies it said supported the idea that SARS-CoV-2 is
airborne. One study (still in preprint and not yet peer reviewed) by Joshua
Santarpia, PhD, and colleagues at the University of Nebraska in Omaha, has
gotten a lot of attention. The researchers collected air and surface samples
from 11 rooms of patients with COVID-19, and found viral RNA in the air both
inside and outside the rooms and on ventilation grates.
Another study in preprint looking at hospitals and public areas in Wuhan
found that the highest concentrations of virus were in toilet facilities and in
PPE removal rooms. Doffing of the PPE may potentially have aerosolized the
virus, the researchers hypothesized.
Differential Diagnosis of Tardive Dyskinesia Differential Diagnosis of Tardive Dyskinesia Check your knowledge with this Fast Five quiz. Begin quiz now Fineberg and colleagues, however, approached the finding with caution, stating that “it may be difficult to re-suspend particles of a respirable size.” More likely, “fomites could be transmitted to hands, mouth, nose, or eyes
without requiring direct respiration into the lungs,” they write.
The report did not cite a recent overview in the Journal of the American
Medical Association by Lydia Bourouiba, PhD, of the Massachusetts Institute
of Technology in Cambridge. The report noted that recent research has found
that “exhalations, sneezes, and coughs not only consist of mucosalivary
droplets following short-range semiballistic emission trajectories but,
importantly, are primarily made of a multiphase turbulent gas (a puff) cloud
that entrains ambient air and traps and carries within it clusters of droplets
with a continuum of droplet sizes.”
She said that the lifetime of a droplet could be extended “from a fraction of a
second to minutes,” and that the cloud carrying viral particles could travel as
Coronavirus Is Aerosolized Through Talking, Exhalation.
The World Health Organization (W.H.O.) still contends (in a report dated March
29) that current evidence shows that “COVID-19 virus is primarily transmitted
between people through respiratory droplets and contact routes,” and that it
can only become airborne during procedures or treatments that generate
aerosols.
Each winter, millions of people suffer from seasonal flu. Flu—the short name for influenza—is caused by viruses. Viruses are very small germs. Some viruses can spread easily from one person to another. They cause illnesses or infections like the flu.
Flu is a mild illness for some people. For older people, especially those who have health problems like diabetes or heart disease, the flu can be very serious, even life-threatening.
How Serious Is Flu?
Most people who get the flu feel much better in a week or two. But, some people can get very sick. For example, because your body is busy fighting off the flu, you might pick up a second infection. Older people are at great risk of these secondary infections, such as pneumonia.
How Does Flu Spread?
The flu is contagious—that means it spreads from person to person, often through the air. You can pass on the infection before you feel sick. You are contagious for several days after you get sick. You can catch the flu when someone near you coughs or sneezes. Or, if you touch something the virus is on, like Ellen and Jack’s phone or doorknob, and then touch your nose or mouth, you could catch the flu. The flu virus can live on a surface like a book or doorknob for a number of hours. Remember to wash your hands often when you are around someone who is sick. Make a point of washing them before eating or touching your eyes, nose, or mouth. If you can, stay away from sick people. That will help stop the flu from spreading.
Is It the Flu or a Cold?
It’s easy to confuse a common cold with seasonal flu. A cold is milder than the flu, but since the flu can make older people very sick, you should know the difference. That way you will know when to call the doctor, who might want to give you a prescription for medicines that can help you get over the flu.
People with the flu can have fever, chills, dry cough, general aches and pains, and a headache. They feel very tired. Sore throat, sneezing, stuffy nose, or stomach problems are less common. What some people call “stomach flu” is not influenza.
Symptoms
If It’s a Cold
If It’s the Flu
Fever
Rare
Usual
Headache
Rare
Common
General aches, pains
Slight
Usual; often severe
Tiredness, weakness
Sometimes
Usual; can last 2 to 3 weeks
Extreme exhaustion
Rare
Usual; when first become sick
Stuffy nose
Common
Sometimes
Sneezing
Usual
Sometimes
Sore throat
Common
Sometimes
Chest discomfort, cough
Mild to moderate hacking cough
Common; can become severe
Can Flu Be Prevented?
Getting a flu shot every year can help you stay healthy. A flu shot contains the flu vaccine, which could keep you from getting the flu. There are special flu shots designed specifically for people age 65 and older. Medicare will pay for the shot, and so will many private health insurance plans. You can get a flu shot at your doctor’s office or from your local health department. Sometimes grocery or drug stores offer flu shots. The vaccine is the same wherever you receive it.
A flu shot won’t keep everyone healthy. But, getting the flu shot every year can mean that if you do get the flu, you might have only a mild case.
Most people get the flu between December and March. That’s why that time is called the flu season. The timeframe can vary each year. It takes at least 2 weeks for your shot to start working, so try to get your flu shot by the end of October. Don’t worry if you can’t get your flu shot before the flu season starts. The shot can help keep you healthy no matter when you get it.
Why Do You Need a Flu Shot Every Year?
You need a flu shot every year for two reasons. First, flu viruses change. Each year’s virus may be just a little different. If the virus changes, the vaccine used in the flu shot is changed. Second, the protection you get from a flu shot lessens with time, especially in older people. So, you should get the shot every fall to do your best to stay protected from the flu.
Are There Side Effects?
Most people have no problem with a flu shot. In fact, for most people, the flu is far more dangerous than the flu shot.
When you get the flu shot, your arm might be sore, red, or a bit swollen. These side effects may start shortly after getting the shot and can last up to 2 days. They should not get in the way of your daily activities. A few people do have a headache or a low-grade fever for about a day after they get the shot. The flu shot cannot cause you to get the flu.
If you are allergic to eggs, you can usually get the flu shot. However, if you have ever had a severe allergic reaction to a flu shot, you should not get a new flu shot.
What Can I Do If I Get the Flu?
If you get the flu, there are things you can do to feel better. First, call your doctor to see if there are medicines that can help. Remind him or her if you are taking drugs to fight cancer or other medicines that make it hard for your body to fight illness. There are prescription drugs, called antivirals, that are used to treat people with the flu. If you take them within 48 hours after the flu begins, these drugs can make you feel better more quickly. Antibiotics do not help you get over the flu. They are sometimes prescribed to help you get over a secondary infection if it is caused by bacteria. Bacteria are a different type of germ than viruses.
Antivirals can also be used to prevent flu. If you hear that there is a flu outbreak in your area, check with your doctor. He or she could prescribe an antiviral that might protect you. Prevention is key. The first choice for preventing the flu is a flu shot.
If you are sick, try to rest in bed and drink plenty of fluids, like juice and water but not alcohol. Medicine such as acetaminophen can bring down your fever, which might help with the aches and pains. It is important not to smoke if you are sick with the flu. It is a respiratory illness that can infect your lungs, as well as your nasal passages. These same areas are also bothered by smoking. Take it easy as much as you can until you are well.
What About the “Bird Flu”?
Sometimes a new, different kind of flu virus appears. You may have heard about the avian or bird flu. This flu is an example of how changes in a flu virus might lead to serious illness. However, there is some good news about bird flu. It is rare in people. In most cases, the bird flu has not passed from one person to another, and so, it might not become widespread in humans. But this could change over time. Scientists are working on new vaccines that can help protect people from bird flu. Right now, having seasonal flu does not build your body’s protection against bird flu.
Things to Remember About the Flu
The flu can be dangerous for older people.
The flu can be prevented.
Older people need a flu shot every year.
Medicare pays for the flu shot.
The flu shot is safe.
For More Information About the Flu
Centers for Disease Control and Prevention (CDC)
1-800-232-4636 (toll-free)
1-888-232-6348 (TTY/toll-free) cdcinfo@cdc.gov www.cdc.gov
This content is provided by the National Institute on Aging (NIA), part of the National Institutes of Health. NIA scientists and other experts review this content to ensure that it is accurate, authoritative, and up to date.
Sometimes parents who seek consultation with me about their child’s worries or fears are surprised to learn that the child has Obsessive-Compulsive Disorder (OCD).
“But she doesn’t wash her hands all the time…”
Or they do not realize that certain symptoms are part of OCD.
“He had bad thoughts that bothered him. He used to tell us about all the time. To get away from that, he developed OCD and started worrying about germs.”
The information that’s out there about OCD can be confusing to navigate, so how is a parent to know if their child is showing signs of OCD? For starters, OCD involves repetitive unwanted thoughts, images, or urges – about any topic imaginable. The key is that these create a great deal of anxiety and/or discomfort. These are the obsessions. A child with OCD gets caught up in an ongoing cycle of trying to rid themselves of that discomfort. Those attempts to feel “better” are compulsions. When obsessions and compulsions get in the way of a child participating in social, school, or family activities it is a disorder.
Let’s bring it all together. What does it look like? For starters, a parent might notice their child being bothered or upset by certain thoughts or even words (e.g., “Mom, my brain keeps saying that you’re ugly. It won’t stop.”). Some kids might repeatedly confess seemingly benign things (e.g., “I’m afraid I might’ve bumped into someone in class today,” “I might’ve looked at my friend with a mean face.”), and look to their parents for reassurance that it’s okay. Other children will repeatedly share fears of getting sick or contaminated, and will be caught up in attempts to prevent this (i.e., by washing, sanitizing, or avoiding certain places or items). Still other children may have worries about people dying or bad things happening. They may beg parents for reassurance that it won’t happen, say special prayers repeatedly, or require parents to engage in elaborate bedtime or goodbye routines (i.e., “You have to say, ‘Goodnight, I love you, bless you, amen!’ No, not that way!”). Sometimes they focus on things needing to be “just right,” such as needing to touch things in a certain order or organizing their toys in a particular way that must not be disturbed.
So, what’s the problem with all this? Won’t it all pass? Besides the obvious result of parents becoming exhausted and frustrated by their child’s confessing, demands for reassurance or participation in routines, and unrelenting string of worries, the child gets stuck. They never learn that they can actually handle their fears and worries and that their compulsions just grow the problem. Sure, sometimes the phase passes, but a new one will pop up in due time, leading to a string of OCD cycles. Children who get caught up in these can miss out on important parts of being a kid. Because they are distracted by what’s going on in their minds, they can struggle to engage socially or miss out on what’s going on in the classroom. The entire family can be impacted when a child’s OCD flares up, as rituals and related emotional outbursts can interfere with family activities (like going to the park or even eating a meal together).
OCD symptoms frequently begin to be seen between ages 8-12, but can also be seen younger. If you suspect your child has OCD, get informed with good information from reputable sources. You might ask your child’s pediatrician about specialists in your area. Not all therapies are created equal when it comes to OCD and some treatments can make things worse, so it is important to identify a provider who has the right training. The Anxiety and Depression Association of America and the International OCD Foundation are excellent places to learn about OCD, about how it is treated, and about how to find a trained specialist who can evaluate and treat it. The sooner you and your child learn the in’s and out’s of OCD, the sooner you can both be on the way to a healthier lifestyle!
Michelle Witkin, PhD, is a licensed psychologist with over 25 years’ experience. She is in private practice in Valencia, California, where she specializes in treating children, teens, and adults with Obsessive-Compulsive Disorder and anxiety disorders. Dr. Witkin is dedicated to educating the public about these conditions. She is a Clinical Fellow of ADAA. She is a graduate of the Pediatric Behavior Therapy Training Institute and the Behavior Therapy Training Institute of the International OCD Foundation. Dr. Witkin has first-hand experience with our topic, as she has raised two terrific young adults, one of whom has OCD.
Lancet Psychiatry. 2018 Dec;5(12):975-986. doi: 10.1016/S2215-0366(18)30384-5. Epub 2018 Nov 15.
Non-trauma-focused meditation versus exposure therapy in veterans with post-traumatic stress disorder: a randomised controlled trial.
Abstract
BACKGROUND:
Post-traumatic stress disorder (PTSD) is a complex and difficult-to-treat disorder, affecting 10-20% of military veterans. Previous research has raised the question of whether a non-trauma-focused treatment can be as effective as trauma exposure therapy in reducing PTSD symptoms. This study aimed to compare the non-trauma-focused practice of Transcendental Meditation (TM) with prolonged exposure therapy (PE) in a non-inferiority clinical trial, and to compare both therapies with a control of PTSD health education (HE).
METHODS:
We did a randomised controlled trial at the Department of Veterans Affairs San Diego Healthcare System in CA, USA. We included 203 veterans with a current diagnosis of PTSD resulting from active military service randomly assigned to a TM or PE group, or an active control group of HE, using stratified block randomisation. Each treatment provided 12 sessions over 12 weeks, with daily home practice. TM and HE were mainly given in a group setting and PE was given individually. The primary outcome was change in PTSD symptom severity over 3 months, assessed by the Clinician-Administered PTSD Scale (CAPS). Analysis was by intention to treat. We hypothesised that TM would show non-inferiority to PE in improvement of CAPS score (Δ=10), with TM and PE superior to PTSD HE. This study is registered with ClinicalTrials.gov, number NCT01865123.
FINDINGS:
Between June 10, 2013, and Oct 7, 2016, 203 veterans were randomly assigned to an intervention group (68 to the TM group, 68 to the PE group, and 67 to the PTSD HE group). TM was significantly non-inferior to PE on change in CAPS score from baseline to 3-month post-test (difference between groups in mean change -5·9, 95% CI -14·3 to 2·4, p=0·0002). In standard superiority comparisons, significant reductions in CAPS scores were found for TM versus PTSD HE (-14·6 95% CI, -23·3 to -5·9, p=0·0009), and PE versus PTSD HE (-8·7 95% CI, -17·0 to -0·32, p=0·041). 61% of those receiving TM, 42% of those receiving PE, and 32% of those receiving HE showed clinically significant improvements on the CAPS score.
INTERPRETATION:
A non-trauma-focused-therapy, TM, might be a viable option for decreasing the severity of PTSD symptoms in veterans and represents an efficacious alternative for veterans who prefer not to receive or who do not respond to traditional exposure-based treatments of PTSD.
Donald Rauh M.D., Ph.D., FAPA
Diplomate of the American Board of Psychiatry & Neurology
Board Certified in General Psychiatry and in Child & Adolescent Psychiatry
Genetic laboratory tests with claims to predict a patient’s response to specific medications, that have not been reviewed by the FDA and may not be supported by clinical evidence. For example, genetic tests with claims to predict whether some medications used to treat depression may be less effective or have an increased chance of side effects.
Purpose
The FDA is alerting patients and health care providers that claims for many genetic tests to predict a patient’s response to specific medications have not been reviewed by the FDA, and may not have the scientific or clinical evidence to support this use for most medications. Changing drug treatment based on the results from such a genetic test could lead to inappropriate treatment decisions and potentially serious health consequences for the patient.
Summary of Problem and Scope
The FDA has become aware of genetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication’s effects has not been determined. These genetic tests might be offered through health care providers or advertised directly to consumers and claim to provide information on how a patient will respond to medications used to treat conditions such as, depression, heart conditions, acid reflux, and others. They might claim to predict which medication should be used or that a specific medication may be less effective or have an increased chance of side effects compared to other medications due to genetic variations. Results from these tests may also indicate that the health care provider can or should change a patient’s medication based on results from these tests. The FDA is also aware of software programs that interpret genetic information from a separate source that claim to provide this same type of information. However, clinical evidence is not currently available for these genetic tests or software programs and, therefore, these claims are not supported for most medications.
For example, the FDA is aware of genetic tests that claim results can be used to help physicians identify which antidepressant medication would have increased effectiveness or side effects compared to other antidepressant medications. However, the relationship between DNA variations and the effectiveness of antidepressant medication has never been established. The FDA is aware that health care providers may have made inappropriate changes to a patient’s medication based on the results from genetic tests that claim to provide information on the personalized dosage or treatment regimens for some antidepressants. Patients and health care providers should not make changes to a patient’s medication regimen based on the results from genetic tests that claim to predict a patient’s response to specific medications, but are not supported by scientific or clinical evidence to support this use, because doing so may put the patient at risk for potentially serious health consequences.
There are a limited number of cases for which at least some evidence does exist to support a correlation between a genetic variant and drug levels within the body, and this is described in the labeling of FDA cleared or approved genetic tests and FDA approved medications. The FDA authorized labels for these medical products may provide general information on how DNA variations may impact the levels of a medication in a person’s body, or they may describe how genetic information can be used in determining therapeutic treatment, depending on the available evidence.
Descriptions for how to use genetic information to manage therapeutic treatment can be found in the following sections of the FDA approved drug labeling: warnings (Boxed Warning, or Warnings and Precautions sections), Indications and Usage, Dosage and Administration, or Use in Specific Populations, as appropriate.
Recommendations for Patients
Do not change or stop taking any medicine based on a report from a genetic test you took on your own. Discuss the results of the genetic test with your health care provider, including whether the medication label includes information on how to use genetic information to determine dosage, and whether your health care provider recommends changes to your treatment. Medicine should always be taken as prescribed by your health care provider.
Be aware that most genetic tests that make claims about the effects of a specific medicine are not supported by enough scientific information or clinical evidence.
Recommendations for Health Care Providers and Laboratories
If you are using, or considering using, a genetic test to predict a patient’s response to specific medications, be aware that for most medications, the relationship between DNA variations and the medication’s effects has not been established. Check the FDA-approved drug label, or the label of the FDA-cleared or approved genetic test for information regarding whether genetic information should be used for determining therapeutic treatment.
If a patient brings you a test report from a genetic test offered directly to consumers that claims to predict a person’s response to a specific medication, seek information in the FDA-approved drug label regarding whether genetic information should be used for determining therapeutic treatment.
Be aware that there are some FDA-approved drug and genetic test labels, and labels of FDA-cleared genetic tests that provide general information about the impact of DNA variations on drug levels, but do not describe how that genetic information can be used for determining therapeutic treatment. These labels are intended to be informational, but do not indicate that there is evidence to support making treatment decisions based on the information provided by the genetic test.
Know that information regarding therapeutic treatment recommendations for patients with certain genetic variations can be found in the warnings (Boxed Warning, or Warnings and Precautions), Indications and usage, Dosage and Administration, or Use in Specific Populations sections of the FDA approved drug labeling, as appropriate.
Be aware that most genetic tests that make claims regarding effects of a specific medication have not been evaluated by the FDA.
Recommendations for Genetic Test Manufacturers and Developers
If your test claims to predict a patient’s response to specific medications, confirm that the FDA-approved drug labels for medications included in your test labeling describe how genetic information can be used in determining therapeutic treatment. Know that information regarding therapeutic treatment recommendations for patients with certain genetic variations can be found in the warnings (Boxed Warning, or Warnings and Precautions), Indications and usage, Dosage and Administration, or Use in Specific Populations sections of the FDA approved drug labeling, as appropriate.
Assure your test report and any labeling support an intended use that is consistent with the FDA-approved use of the medication.
Contact the FDA if you have any questions about genetic tests that are intended to be used to direct use of specific medications.
FDA Actions
The FDA is looking into certain developers that may be inappropriately selling genetic tests for the unapproved uses noted above and will take compliance actions when appropriate, such as when the tests pose significant public health concerns.
Following issuance of the safety communication, FDA reached out to several firms marketing pharmacogenetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication’s effects has not been established. Most firms addressed the FDA’s concerns by removing specific medication names from their labeling, including promotional material and patient test reports.
On April 4, 2019, the FDA issued a warning letter to Inova Genomics Laboratory, of Falls Church, VA, for illegally marketing genetic tests that claim to predict patients’ responses to specific medications, also known as pharmacogenetics tests.
The FDA will continue to monitor this issue and will keep the public informed if significant new information becomes available.
Reporting Problems to the FDA
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with these products. If you suspect or experience a problem with a laboratory test, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirementsshould follow the reporting procedures established by their facilities.
If you have questions about this communication, please contact CDRH’s Division of Industry Communication and Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041, or 301-796-7100.
