“Respiratory Distress in Young Girl - Clinical Advisor” plus 3 more
“Respiratory Distress in Young Girl - Clinical Advisor” plus 3 more |
- Respiratory Distress in Young Girl - Clinical Advisor
- Neurelis Announces FDA Approval Of Extended Expiration Dating For VALTOCO® (Diazepam Nasal Spray) - BioSpace
- Extracorporeal membrane oxygenation shows benefit for patients with COVID-19 related severe acute respiratory distress syndrome. - 2 Minute Medicine
- Symptoms, recovery, aftermath: What we don’t know about COVID-19 - Al Jazeera English
| Respiratory Distress in Young Girl - Clinical Advisor Posted: 19 Oct 2020 06:00 AM PDT  Anna, a 4-year-old girl with a history of asthma, was taken by her parents to an urgent care clinic where she was diagnosed with an upper respiratory infection and streptococcal pharyngitis for which she was prescribed an antibiotic. Two days later, her parents brought her into the emergency The child previously had visited the same ED over 30 times and had been admitted several times. The child arrived at the hospital at 2:00 AM and was seen by a team consisting of Dr E and Nurse R. Within 3 minutes of the patient's arrival, Dr E ordered that the patient be given ipratropium and albuterol by nebulizer. By 2:11 AM, Nurse R had completed her triage assessment. She noted that Anna had labored breathing and was wheezing. Her pulse was 156 beats/min, respiration rate was 36, and pulse oximetry on room air was 91%. Twenty minutes later, Nurse R noted in the chart that Anna had tolerated the ipratropium and albuterol treatment well, with no adverse reactions, and that her respiratory status improved. At approximately 2:30 AM, Dr E examined the child and determined that she no longer had signs of respiratory distress. She was breathing normally without the use of accessory muscles, and although she was wheezing, the doctor noted in the chart that the symptoms were "mild." At 2:45 AM the child, with her mother accompanying her, was taken to radiology for a chest radiograph. A half hour later, Nurse R noted that Anna was administered albuterol inhalation. Continue Reading At approximately 3:30 AM, Nurse R took the child's vitals again. They were recorded in the chart as pulse rate, 145 beats/min; respiration rate, 34 breaths/min, and pulse oximetry level, 99%; however, the chart did not specify whether this rate was measured on room air or with supplemental oxygen. A short while later, Nurse R administered dexamethasone to the patient. At 3:50 AM, Dr E reviewed Nurse R's notes, Anna's vital signs, the laboratory results, and radiology report. He met with Anna's parents and spoke to them about her condition. He told them that the test results did not support admitting her to the hospital, but he stressed the need for outpatient followup care. He said that her condition was "back to baseline," noting that her symptoms had resolved after treatment. The child's mother was concerned that Anna was still wheezing and breathing faster than normal, but the physician ordered that she be discharged. Nurse R noted that the child had tolerated both the albuterol and dexamethasone treatments with no adverse reaction and that her respiratory status improved. The child was discharged at 4 AM. During the 2 hours that Anna had been in the ED, she was examined by Dr E once, a half hour after her arrival. The physician did not see her again prior to discharge. Anna's parents took her to her grandmother's house after she was discharged because they had to go to work. At approximately 7 AM, the grandmother found Anna unresponsive and called 911. The child was taken by ambulance to the hospital, where she was treated for respiratory and cardiac arrest, leading to brain death. She was taken off life support 6 days later and died. | |||
| Posted: 19 Oct 2020 06:16 AM PDT | | SAN DIEGO, Oct. 19, 2020 /PRNewswire/ -- Neurelis, Inc.. announced today that the U.S. Food and Drug Administration (FDA) has granted extended expiration dating for the company's lead product, VALTOCO® (diazepam nasal spray). VALTOCO was approved by the FDA on January 10, 2020, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in adult and pediatric patients 6 years of age and older. At the time of approval, the FDA also granted VALTOCO 7 years of Orphan Drug Exclusivity. The FDA recognized VALTOCO's intranasal route of administration as clinically superior to the previously approved standard-of-care treatment (a rectal gel formulation of diazepam) as part of the Orphan Drug Exclusivity designation.
"We are excited that the FDA has extended the VALTOCO product expiration to more than two years," said Craig Chambliss, the company's President and Chief Executive Officer. "Seizure emergencies can happen at any time and any place. Patients, care partners, and healthcare providers need a reliable product that is available when and where they need it." In the United States, there are more than 3.4 million people with epilepsy, with approximately 200,000 new patients diagnosed each year. Despite the availability of daily oral medications to control chronic epilepsy, a significant number of these patients continue to experience seizures. Of these uncontrolled patients, as many as 170,000 are at risk for episodes of frequent seizure activity, also known as cluster or acute repetitive seizures, representing a significant unmet need in the epilepsy community. About VALTOCO VALTOCO is a proprietary formulation of diazepam incorporating the science of Intravail®. Intravail transmucosal absorption enhancement technology enables the noninvasive delivery of a broad range of protein, peptide, and small-molecule drugs. In its approval of VALTOCO, the FDA also granted Neurelis Orphan Drug Exclusivity and recognized VALTOCO's intranasal route of administration as a clinically superior contribution to patient care over the previously approved standard-of-care treatment (a rectal gel formulation of diazepam). In a long-term, open-label, repeat-dose clinical trial, the safety of VALTOCO was evaluated and more than 4,000 seizures were treated. The clinical trial included adult and pediatric patients aged 6 and older. VALTOCO was generally safe and well tolerated during clinical studies. The most common adverse reactions for diazepam (at least 4%) were somnolence, headache, and nasal discomfort. For more information on VALTOCO, please visit www.valtoco.com. About Neurelis Neurelis, Inc., is an innovation-driven neuroscience company providing a highly differentiated approach to target unmet medical needs. Neurelis is focused on the development and commercialization of product candidates for epilepsy and the broader central nervous system (CNS) market. On January 10, 2020, the U.S. Food and Drug Administration (FDA) approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older. In addition to VALTOCO, the company is developing NRL-2 for intermittent use to control acute panic attacks, NRL-3 as a noninvasive acute therapy to stop seizures that have progressed to status epilepticus, and NRL-4 as a noninvasive rescue therapy to address the escalation of psychomotor agitation (PMA) symptoms outside of the medical setting. The Neurelis technology platform includes Intravail®, ProTek® and Hydrogel™, three proprietary, noninvasive drug-delivery and stabilization technologies applicable to a wide range of molecules, including therapeutic proteins, peptides, non-peptide macromolecules, and small molecules. For more information on Neurelis, please visit www.neurelis.com. Important Safety Information about VALTOCO: Indication IMPORTANT SAFETY INFORMATION RISK FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
Contraindications: VALTOCO is contraindicated in patients with:
Central Nervous System (CNS) Depression Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to a healthcare provider. Glaucoma Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma. Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol-preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Adverse Reactions The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance. To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch). Please read full Prescribing Information, including Boxed Warning, for additional important safety information. For More Information:
SOURCE Neurelis, Inc. | |
| Posted: 19 Oct 2020 05:11 AM PDT  1. Extracorporeal membrane oxygenation (ECMO) for COVID-19 related acute respiratory distress syndrome (ARDS) was associated with 60-day survival rates similar to other studies evaluating ECMO in severe ARDS. 2. ECMO in COVID-19 related ARDS was associated with an increased risk of pulmonary emboli despite thromboprophylaxis. Evidence Rating Level: 2 (Good) Study Rundown: There are over 17 million confirmed cases of COVID-19 internationally. Severe and critical COVID-19 may be associated with acute respiratory distress syndrome (ARDS) and severe hypoxemia. Previous case series from China found that COVID-19 related ARDS responded poorly to extracorporeal membrane oxygenation (ECMO), despite recommendations for its use worldwide during the pandemic. This multi-centre retrospective cohort study attempted to further characterize the use of ECMO in patients with severe COVID-19 ARDS. Patients receiving ECMO for COVID-19 related ARDS were included, and clinical status (and time spent in different clinical states) up to day 90 post-ECMO was the primary outcome of interest. Overall, patients on ECMO showed similar 60-day survival as previous studies of patients with non-COVID-19 related severe ARDS. Prone positioning prior to ECMO was associated with significant benefit. Despite thromboprophylaxis, there was an increased risk of pulmonary emboli in this population, consistent with previous reports of SARS-CoV-2 with associated lung endothelial injury. This study supports consideration of ECMO in the early management of patients with profound respiratory failure refractory to optimized conventional care including prone positioning. Limitations include only enrolling patients from sites highly experienced with ECMO use, limiting generalizability to less experienced and resource-limited sites. Click to read the study in Lancet Respiratory Medicine Click to read an accompanying editorial in Lancet Respiratory Medicine Relevant reading: Poor survival with extracorporeal membrane oxygenation in acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) In-Depth [retrospective cohort]: This multi-center retrospective cohort study occurred in five hospitals across Paris, France, and enrolled 83 patients (median age 49, interquartile range [IQR] 41 to 56 years); 61 (73%) were men. Patients with laboratory-confirmed SARS-CoV-2 infection who received venoarterial or venovenous-ECMO for severe acute respiratory distress syndrome (ARDS) were included. ECMO was contraindicated if patients were over 70 years old or had other severe comorbidities, recent cardiac arrests, or invasive ventilation for longer than 10 days. The primary outcome was clinical status in one of four states: (i) on ECMO; (ii) in the intensive care unit (ICU) and weaned off ECMO; (iii) alive and out of ICU; and (iv) death. Clinical outcomes were assessed at several timepoints after beginning ECMO, up to day 90 post-ECMO initiation. Secondary outcomes involved characterizing complications related to ICU stay or ECMO. Among the 83 patients for whom ECMO was initiated, 67 (81%) were prone positioned, 80 (96%) received neuromuscular blockers, 17 (20%) received high-dose corticosteroids, and five (6%) received nitric oxide. ECMO support was provided for a median duration of 20 days (IQR 10 to 40), and median ICU length of stay was 36 days (IQR 23 to 60). Complete follow-up was available at 60 days for all 83 patients. The estimated likelihood of being in each of the four states at 60 days post-ECMO initiation were calculated as follows: (i) 6% (95% confidence interval [CI] 3 to 14%); (ii) 18% (95% CI 11 to 28%); (iii) 45% (95% CI 35 to 56%); and (iv) 31% (95% CI 22 to 42%). Amongst patients who were prone positioned, 94% showed benefit. Despite appropriate thromboprophylaxis, 16 (19%) patients developed a pulmonary embolism, which was higher than observed in patients with non-COVID-19 related ARDS on ECMO. 35 (42%) patients experienced major bleeding, with 4 (5%) experiencing hemorrhagic strokes. There were 30 deaths observed in follow-up. Overall, given similar rates of survival to patients with non-COVID-19 ARDS on ECMO from previous studies, the use of ECMO in COVID-19 ARDS should be considered as a treatment modality for patients refractory to conventional optimization including prone positioning. Image: PD ©2020 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc. | |||
| Symptoms, recovery, aftermath: What we don’t know about COVID-19 - Al Jazeera English Posted: 19 Oct 2020 01:26 AM PDT  Across the globe, doctors, researchers and scientists are working around the clock to investigate the ways COVID-19 affects the human body – and there is a lot we are still learning. Mild vs severe cases: Rate of recoveryRecovery time for those with COVID-19 varies. This is due to a number of factors, including whether a patient has underlying or associated chronic conditions, whether they have a mild or severe case, and whether or not they become critically ill. Anecdotally, we know that the more critical a case is, the longer the duration of the illness. For severe cases that required hospitalisation, the average amount of time spent undergoing hospital treatment is between seven and 14 days. But for those who become critically ill, needing to go on a ventilator or into intensive care, this number may increase to between 30 and 40 days. For those with mild symptoms, meaning they did not need hospital care, most experience a shorter illness and recover quickly. However, there are now reports of some people even with mild disease who continue to experience persistent symptoms, and do not return back to usual health – even months later. COVID-19's effect: The body can 'malfunction'If a patient has a mild illness, they usually experience symptoms such as a fever, cough, sore throat, fatigue and, in some cases, loss of smell or taste. If a patient is critically ill, that usually means their respiratory system is not working or they have other organ problems – such as severe pneumonia, acute respiratory distress syndrome or sepsis, which can lead to multi-organ failure. In other words, the patient's body is malfunctioning. Critical patients may experience prolonged viral shedding – which is the period when the virus is detectable and potentially transmissible. But even if they are no longer infectious with SARS-CoV-2, their critical illness can be prolonged. It is likely that these patients are having an abnormal immune system response, which causes inflammation and injury to the cells lining the small blood vessels, tissue swelling, and injury to the organs themselves. In the lungs, for example, this injury is called Acute Respiratory Distress Syndrome (ARDS). It develops as a result of injury to the cells lining the lung's air sacs and the cells lining the small vessels (endothelium) that bring blood to the lungs for oxygen. This causes fluid and proteins to fill up the air sacs, and the injury to the endothelium can activate blood clotting, tissue swelling and low blood oxygen levels. Sepsis: A life-threatening conditionCOVID-19 is known to be a respiratory disease. So how does it cause organs to malfunction and fail? The answer can be found in a life-threatening condition called sepsis. When faced with any infection, the body and the immune system reacts. But if an infection becomes severe, it can cause an abnormal immune response – like sepsis. If this happens, it is not the infection itself causing problems, but rather the body's response to the infection, which causes injury to its own tissues and organs. In some patients with a severe or critical case of COVID-19, the virus makes them sick, invades their lungs and causes severe pneumonia. In some patients, as their body tries to fight the infection it may overreact, and they develop sepsis. The combination of sepsis and COVID-19 means it is no longer just pneumonia in the patient's lungs. Pneumonia will be there, but the additional abnormal immune response – the sepsis – can cause tissue damage, multi-organ failure and even death. Immunosuppressed people – patients with chronic diseases – are more likely to get sepsis than patients with a normal immune system. To prevent sepsis from occurring, an effective COVID-19 vaccine is needed, or an antiviral treatment – which is an agent that suppresses a virus's ability to replicate. But as yet, there are no approved options, so we cannot intervene against the virus in these ways. Another approach is to modulate a patient's immune system, asking what we can do to stop the abnormal immune response from causing damage. Steroids, like dexamethasone or hydrocortisone, have shown promise in this regard. They reduce mortality in patients with severe or critical COVID-19. However, if taken for mild cases, steroids do not work and may cause harm and even death. Supportive care: A mainstayIn the absence of a viable vaccine and while other therapeutics are being tested, supportive care becomes the mainstay from the moment a patient shows the first signs of distress or severe symptoms, signalling that they need an intervention. One of the first signs can be fast breathing and low oxygen levels, meaning the patient should get oxygen immediately. In patients who are critical, oxygen may need to be delivered via a ventilator or other higher-flow oxygen support systems. Without enough oxygen being pumped around the body via the bloodstream, the body's cells get more damaged and this may cause the organs to fail faster. One of the items on the WHO's Essential Medicine List, oxygen is life-saving and countries should ensure their hospitals have an adequate supply. Good, optimised supportive care that helps maintain the patient's oxygen level and blood pressure will hopefully allow the body to heal itself. After the organs have healed, the patient can be taken off supportive care so they can recover naturally. Long-term effectsThere is still a lot we are learning about COVID-19, but the main symptoms and deficits we are watching out for in the long term are respiratory, neurological, cardiac and physical. First, we have to monitor former patients to see if the lungs heal and return to their pre-coronavirus state. Next, we must pay attention to neurological problems – psychological or psychiatric concerns, including depression and anxiety, but also poor concentration and complications such as a stroke. Finally, we need to pay attention to a patient's physical mobility. After weeks in a hospital bed without much movement, the muscles and joints are affected, so we have to track any physical limitations. Other than these three main areas, we need to monitor any organs that were affected while the patient was in hospital – such as the heart for those who developed cardiac issues. We need to watch to see whether those who experienced heart troubles while in hospital have similar problems later. We know now, that some patients with mild disease, can also experience persistent symptoms such as fatigue, shortness of breath, or headaches and not return to their usual health. Post-COVID-19 disorders need to be better understood. The long-term immune response to the virus is also something we are slowly figuring out. It is still unclear how much immunity a person has after being infected, how different the immune response is for those who had mild, moderate and severe cases, and how long the immunity will last. Immune responses are complicated, as is our immune system – there is a lot we all still need to learn. |
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