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Officials with the FDA expanded the approved indication for baloxavir marboxil (Xofluza; Genentech) to include post-exposure prevention of influenza for patients aged 12 years and older, after contact with an individual who has the flu. The therapy previously available only in tablet form, is also now available as granules for mixing in water.

Baloxavir marboxil was originally 

 for treating uncomplicated flu in patients aged 12 years and older who have been symptomatic for no more than 48 hours. Its’ indication was first 

 for patients aged 12 years and older who are at high risk for developing influenza-associated complications.

Baloxavir marboxil’s safety and efficacy for post-flu exposure prevention is supported by a randomized, double-blind, controlled trial in which 607 subjects, aged 12 years and older who were exposed to a person with influenza in their household, received either a single dose of baloxavir marboxil or a single dose of a placebo. Of these 607 subjects, 303 received baloxavir marboxil and 304 received the placebo.

According to the FDA, the trial’s primary endpoint was the proportion of subjects who were infected with influenza virus and presented with fever and at least 1 respiratory symptom from day 1 to day 10. Of those who received baloxavir marboxil, 1% of subjects met these criteria, compared to 13% of subjects who received a placebo for the clinical trial.
The most common adverse effects of baloxavir marboxil include diarrhea, bronchitis, nausea, sinusitis and headache. Additionally, hypersensitivity, including anaphylaxis, can occur in patients taking baloxavir marboxil.

Patients should be advised not be co-administer baloxavir marboxil with dairy products, calcium-fortified beverages, or laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminum or zinc.

Flu is a contagious respiratory illness caused by influenza viruses. According to the FDA, treating flu patients with antiviral drugs within 48 hours of their becoming sick can reduce symptoms and duration of the illness. An annual seasonal flu vaccine is the best way to protect against the flu.






FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention [news release]. Silver Spring, MD; November 23, 2020: FDA. Accessed November 23, 2020. 

https://www.fda.gov/news-events/press-announcements/fda-expands-approval-influenza-treatment-post-exposure-prevention

Articles

Officials with the FDA expanded the approved indication for baloxavir marboxil (Xofluza; Genentech) to include post-exposure prevention of influenza for patients aged 12 years and older, after contact with an individual who has the flu.

FDA Expands Indication of Antiviral Therapy to Include Post-Exposure Influenza Prevention

Contemporary Clinic spoke with Daniel R. Wilson, MD, PhD, President of Western University of Health Sciences, about the impact that COVID-19 is having on the brain.

Wilson explained how certain people with COVID-19 are experiencing post-COVID-19 symptoms of cognitive changes, such as clarity in thinking and memory. 

In addition, Wilson also discusses the importance of focusing on the cognitive long-term effects of the virus and specific trials regarding this topic. 

Videos

The Neurological Impact of COVID-19

, patient with diabetes Phyllisa Deroze, PhD, and Joseph Delahunty, Global Head of Communications at Ascensia Diabetes Care, said that supporting patients’ mental health is just as important as their physical health, especially when it comes to chronic conditions, such as diabetes.

Deroze is a participant in Ascensia Diabetes Care’s 2020 World Diabetes Day campaign, which promoted the theme “Nurses Make the Difference for Diabetes” by sharing videos of 28 patients with diabetes who have written letters to their nurses to express their appreciation and gratitude. Deroze said she wrote about a nurse who gave her the skills and confidence to administer her own insulin and supported her during the emotional period following her diagnosis.

“[Nurses] really are a key and central part of diabetes management,” Delahunty said. “Some of the key messages this year are not just highlighting the important role that they play, but also the need to have more nurses and the importance in investing in education and training for nurses so that they have the right expertise to help people with diabetes.”

Supporting patients’ mental health is just as important as their physical health, especially when it comes to chronic conditions, such as diabetes.

Nurses Can Support Diabetes Patients Both Medically, Emotionally

The FDA has approved sodium sulfate, magnesium sulfate, and potassium chloride tablets (Sutab; Sebela Pharmaceuticals) for colonoscopy preparation.

A colonoscopy is the most common method of colorectal cancer detection. Prior to a colonoscopy, patients need to complete a liquid bowel preparation.

The tablets offer patients an alternative, especially for those who have trouble completing the liquid bowel preparation. Colorectal cancer is one of the leading causes of cancer-related deaths, and screening is crucial for effective management. Every year, 19 million colonoscopies are performed in the United States.

The approval was based on 2 trials in which 92% of patients achieved successful bowel cleansing by using the tablet. Cleansing in all segments of the colon, including the proximal colon, was achieved in 92% to 95% of patients.

In one of the trials, the tablets were deemed easy and tolerable to consume in 91% of participants. A significant majority of participants, 78%, said they would use the tablets again for a future colonoscopy.

“Successful bowel prep is critical for gastroenterologists to clearly see any polyps or abnormalities, yet the immense volume of liquid prep solutions can prevent patients from adequately completing their regimens. Tablets provide a welcome alternative for successful prep completion and visualization of the colon,” said Douglas K. Rex, MD, director of Endoscopy at Indiana University Hospital and Professor, Department of Medicine, Division of Gastroenterology and Hepatology, University of Indiana School of Medicine, in a press release.

Compared with the competitor, more patients taking the tablets reported nausea and vomiting, according to the press release. More than half of patients, 52%, reported at least 1 selected gastrointestinal adverse reaction.

Sebela Pharmaceuticals Receives FDA Approval for SUTAB® Tablets for Colonoscopy Preparation [News Release] November 10, 2020; Braintree, MA. Accessed November 11, 2020.

Sutab tablets provide an alternative to traditional liquid bowel preparation, which is hard to complete for some patients.

FDA Approves Alternative to Traditional Colonoscopy Preparation

Researchers at Tampere University and LUT University, both in Finland, studied exoskeleton vests worn by nurses to discover how the new technology would suit the special requirements of patient care. These investigators found that exoskeletons can reduce physical strain.1,2

The studies come from the increased use of wearable exoskeletons in physically demanding jobs to support good ergonomics and augment muscular strength, according to results published in the journal 

"This message from the field led us to investigate what conditions exoskeletons would need to meet in order to reform nursing," said Tuuli Turja, postdoctoral research fellow at Tampere University, in a prepared statement. "Currently, exoskeletons are mainly used in manufacturing and logistics. Isn't it high time to introduce exoskeletons in female-dominated sectors, where musculoskeletal disorders are rampant?"2

Exoskeleton-type technology is generally utilized in rehabilitation settings, where patients wear the skeleton of a walking robot, for example. The latest study article focuses on 2 studies involving users of the Laevo Exoskeleton, a wearable back support vest, which alleviates lower back strain by 40 to 50%, according to the manufacturer.1,2

The first study found pairs of nursing students assisted geriatric patients in moving from a hospital bed into a wheelchair with and without the exoskeleton, whereas the second study found 7 nurses tested the exoskeleton vest in a real care environment for a week.1,2

The study results showed that due to the special characteristics of patient care, exoskeletons need to be developed further before being completely suitable for everyday nursing work. In addition, nurses are willing to use exoskeletons to assist their work if the devices are comfortable and effortless to use and product development considers the requirements of nursing, such as interactive features and safety, in hectic work situations, according to the study authors.1,2

Turja T, Saurio R, Katila J, Hennala L, Pekkarinen S, Melkas H. Intention to Use Exoskeletons in Geriatric Care Work: Need for Ergonomic and Social Design. 

. 30, September 2020. doi:10.1177/1064804620961577

Exoskeletons can reduce strain also in health care. Tampere University. 

https://www.tuni.fi/en/news/exoskeletons-can-reduce-strain-also-health-care

. Published November 10, 2020. Accessed November 11, 2020.

The studies come from the increased use of wearable exoskeletons in physically demanding jobs to support good ergonomics and augment muscular strength.

Study Finds Exoskeletons Can Reduce Strain in Health Care

A paper published recently in the journal 

 found that nurses and other health care providers should talk to patients about their cannabis use the same way they discuss other habits, such as smoking and drinking, routinely and without judgment.

The shared decision-making model starts with either the patient or the provider bringing up the topic of cannabis use then moving on to specifics about the patient’s situation, benefits, and risks of cannabis use based on research and evidence, and finally formulating a plan, according to the paper.

“Central to patient-centered conversations is understanding the top priorities of patients,” wrote Marian Wilson, RN, associate professor at the Washington State University College of Nursing, in the paper. “Researchers have suggested that clinicians should ask ‘What matters to you?’ as well as ‘What is the matter?’”

Certain studies have suggested cannabis use is beneficial to patients with chronic pain who are using opioids, since so many in the patient population are using cannabis or considering it. This reason is why the study authors found it important for providers working in pain management to discuss the subject, even though patients may be reluctant to disclose cannabis use because they might have been penalized in the past.

Wilson noted that providers face real challenges in obtaining current, evidence-based information on benefits and risks of cannabis use. The paper calls for the creation of a centralized, noncommercial, scientific repository of information, research, and best practices on cannabis use.

“We want providers to ask people about their cannabis use and we want patients to feel comfortable talking about it, but right now many don’t,” Wilson said in the paper.

Paper urges healthcare providers to routinely ask patients about cannabis use. Washington State University. 

https://news.wsu.edu/2020/11/05/paper-urges-healthcare-providers-routinely-ask-patients-cannabis-use/

. Published November 5, 2020. Accessed November 6, 2020.

Certain studies have suggested cannabis use is beneficial to patients with chronic pain who are using opioids, since so many in the patient population are using cannabis or considering it.

Research Paper Urges Health Care Providers to Routinely Ask Patients About Cannabis Use

Contemporary Clinic spoke with Teri Moser Woo, PhD, ARNP, CPNP-PC, CNL, FAANP, about Antibiotic Awareness Week.

Woo addressed that this week, which takes place from November 18-24, is a good time to reflect on what health care providers are actually prescribing, the appropriateness of what they are prescribing, and to know if each antibiotic is the right one for the pathogen that you are treating. 

Woo also discussed the COVID-19 pandemic, stewardships, the threat of antibiotic resistance, and the future of nurse practitioners with antibiotics. 

What to Know Ahead of Antibiotic Awareness Week 2020

A University of California, Los Angeles-led review of 9 years of social media posts with the hashtag #BCSM suggests that Twitter can be a useful resource not only for patients, but also for physicians and researchers, according to a press release.

The hashtag, an acronym for “breast cancer social media,” first appeared on Twitter in 2011 and was used to curate a weekly informational chat for people with breast cancer.

The research found that between January 1, 2011, and January 1, 2020, #BCSM was used more than 830,000 times by more than 75,000 unique Twitter accounts, generating 4 billion impressions. Further, the hashtag was used 145,600 times in 2019 alone, an increase of 424% from 2011 when it appeared 27,700 times.

The study was intended to help researchers understand the impact of the community that grew around the Twitter chat. The results revealed that the rise of social media in everyday life paralleled with the growing popularity of #BCSM demonstrated that an increasing number of people with breast cancer are turning to online communities for support and education, according to the study.

“The #BCSM online community has experienced tremendous growth since its inception because it has helped fulfill a need among patients who were searching for information and support on the platform,” said lead study author Deanna Attai, MD, assistant clinical professor of surgery at the David Geffen School of Medicine at UCLA, in a press release.

Attai added that it has helped physicians gain insight into the patient perspective and has given them a better understanding of their many issues.

“We often see patients in a much different setting. Compared to our exam room interactions, online is a more raw, unvarnished look into what patients are really going through,” Attai said.

The #BCSM platform has given health care professionals the opportunity to correct misconceptions, provide guidance to people with breast cancer, and steer them toward credible resources, according to the study. Using Symplur, a health care-focused analytics program commonly used to study trends on Twitter, data were compiled on the use of the hashtag.

The study noted that the inclusive nature of the #BCSM hashtag has contributed to its popularity, since it is not restricted by gender or people’s stage of diagnosis. However, its extent may limit how sustainable the online community will be. As cancer therapy becomes more personalized, people may increasingly seek out support groups that are more closely aligned with their own clinical situations.

How a Twitter hashtag provides insights for doctors and support for people with breast cancer. UCLA Newsroom. 

https://newsroom.ucla.edu/releases/bcsm-twitter-breast-cancer-support

. Published October 22, 2020. Accessed October 27, 2020.

A UCLA-led review of 9 years of social media posts with the hashtag #BCSM suggests that Twitter can be a useful resource for patients, physicians and researchers

Twitter Hashtag Provides Insights for Physicians, Support for People with Breast Cancer

A new scoring model can help predict hospitalization, critical illness, or death for coronavirus disease 2019 (COVID-19) presenting patients at urgent care centers, according to a study published in

The COVID-19 pandemic has caused over 1.2 million deaths and there have been more than 46.8 million confirmed cases worldwide, according to the World Health Organization.

 The virus has had a dramatic effect on the health care system, including urgent care facilities.

In order to help limit the spread of COVID-19, Massachusetts General Hospital closed most outpatient facilities and set up new Respiratory Illness Clinics, according to the study. The clinics were staffed by reassigned nurses and clinicians, and many had little urgent care experience. Investigators developed a COVID-19 Acuity Score (Cova) in order to better determine a patient’s risk for hospital admission, ICU admission, or death within 7 days.

The score uses demographic, medical history, clinical, and radiographic variables to determine risk. Data was collected between March 7, 2020 and May 14, 2020. All patients were assigned to a developmental cohort or a prospective cohort, and were admitted through the emergency department or the respiratory clinics.

Investigators found that in the developmental cohort, which was made up of 9381 people, 35.6% of patients had adverse events within 7 days of presentation, 27.3% were hospitalized, 7.2% received treatment in an intensive care unit (ICU) or mechanical ventilation, and 1.1% had died. In the prospective cohort, which was made up of 2205 people, 32.9% of patients had adverse events, 26.1% were hospitalized, 6.3% received ICU treatment or mechanical ventilation, and 0.5% died, according to the study.

"While several other groups have developed risk scores for complications of COVID-19, ours is unique in being based on such a large patient sample, being prospectively validated, and in being specifically designed for use in the outpatient setting, rather than for patients who are already hospitalized," Shivani Mukerji, MD, PhD said in a prepared statement. "Cova is designed so that automated scoring could be incorporated into electronic medical record systems. We hope that it will be useful in case of future COVID-19 surges, when rapid clinical assessments may be critical."

Haoqi S, Aayushee J, Leone M, et al. Cova: An Acuity Score for Outpatient Screening that Predicts COVID-19 Prognosis. 

. Published October 24, 2020. Accessed October 30, 2020. https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiaa663/5938525

WHO Coronavirus Disease (COVID-19) Dashboard

. The World Health Organization. Updated November 3, 2020. Accessed November 3, 2020. 

Risk score predicts prognosis of outpatients with COVID-19 [News Release] October 26, 2020; Boston, MA: Massachusetts General Hospital . Accessed October 30, 2020. https://www.massgeneral.org/news/press-release/Risk-score-predicts-prognosis-of-outpatients-with-covid-19

A new scoring model is helping to determine the risk of hospitalization and death for patients being treated for COVID-19 in outpatient clinics such as urgent care centers.

New Scoring Model Helps Clinics Determine Risk of Hospitalization, Death for Patients With COVID-19 

Among women with breast cancer, colorectal cancer, or melanoma, those who were taking cholesterol-lowering medications were less likely to die from cancer, according to an analysis published in the 

The researchers tested the hypothesis that adherence to lipid-lowering medications (LLMs) is associated with reduced cancer-specific mortality in a homogeneous population who had used these drugs before cancer diagnosis. The Australian Cancer Database was linked to the Pharmaceutical Benefits Scheme database and to the National Death Index up to the year 2015, according to the study.

Further, the medication adherence was calculated by proportion of days covered. Cox regression models with time-varying covariates were used to derive multivariable-adjusted cause-specific hazard ratio and 95% confidence interval for the associations between adherence to LLMs, statins, lipophilic, and hydrophilic statins, and cancer-specific mortality.

From 2003 to 2013, 3 separate cohorts of 20,046, 11,719, and 6430 female patients with newly diagnosed breast, colorectal cancer, and melanoma were identified, respectively. The 1-year adherence was similar at 1-year pre-diagnosis in the 3 cohorts, at an average of 82%.

Additionally, each 10% increase in 1-year adherence to LLMs was inversely associated with cancer-specific mortality among women with breast cancer, colorectal cancer, or melanoma. The reductions in cancer-specific mortality were more pronounced for women who adhered to lipophilic rather than hydrophilic statins in all 3 cancers, although it was not statistically significant for melanoma, according to the study.

The researchers found that among LLM users, adherence to the drug is associated with a decrease in cancer-specific mortality. If confirmed, LLMs could be considered as an adjuvant cancer therapy to improve prognosis in cancer survivors, according to the study.

Cholesterol medications linked to lower cancer-related deaths in women. EurekAlert! 

https://www.eurekalert.org/pub_releases/2020-10/w-cml101920.php

. Published October 21, 2020. Accessed October 28, 2020.

Feng JL, Qin X. Does adherence to lipid-lowering medications improve cancer survival? A nationwide study of breast and colorectal cancer, and melanoma. 

Among women with breast cancer, colorectal cancer, or melanoma, those who were taking cholesterol-lowering medications were less likely to die from cancer, according to a recent analysis.

Cholesterol Medications Linked to Fewer Cancer-Related Deaths in Women 

Universal mask wearing is critical to prevent the spread of coronavirus disease 2019 (COVID-19) as the pandemic persists throughout the United States.

Evidence consistently demonstrates that mask wearing is one of the best measures to prevent the spread of COVID-19 in a community, and it is recommended by the CDC and other health experts as the best method available to do so.

 Person to person spread of COVID-19 has been known as the primary method of transmission.

However, the CDC recently updated their guidance based on evidence that COVID-19 can sometimes spread by airborne transmission from small droplets and particles that linger in the air for minutes to hours.

 Without federal mask mandates in place, inconsistencies exist across the country as many states have eased restrictions. According to Johns Hopkins University, there have been over 225,000 deaths from COVID-19 in the United States as of October 26, 2020.

An epidemiological study analyzed data across the country from the first recorded case through September 21, 2020 to determine different scenarios for the future trajectory of COVID-19.

The study found different patterns of COVID-19 across the United States, including data that demonstrated that sixth of the deaths (16.6%) occurred in New York alone. Between February and September 2020, the highest levels of daily deaths occurred in New York (998), New Jersey (311), and Texas (220). On September 21, 2020, the highest level of daily deaths occurred in Florida at 101 deaths per day.

The study projected that if states continue to ease restrictions, the total death rate in the United States could reach over 1 million by February 28, 2021.

 In addition, the study predicted that if states begin to shut down social interaction and the economy when daily deaths reach a threshold of 8 deaths per million, the projected death toll is predicted to decrease to 511,373 deaths by February 28, 2021. The implementation of universal mask use, or 95% mask use by the general public, is predicted to result in better outcomes as the pandemic surges in many states and is estimated to save an additional 129,574 lives from September 22, 2020 through the end of February 2021.

This study provides important evidence about what the future could hold for the United States in terms of COVID-19 deaths and the critical nature of universal mask use to save lives. Limitations of the study include that it involved estimations of real-world scenarios and the rapidly evolving nature of the COVID-19 pandemic, which may not be accounted for in the analysis.

, Anthony Fauci, MD, National Institute of Allergy and Infectious Diseases director, calls for universal mask adherence, keeping distance from others, and frequent handwashing measures, especially as the winter months approach.

“They sound very simple. But we’re not uniformly doing that and that’s one of the reasons we’re seeing these surges,” said Fauci in the interview.

Health care professionals can play a critical role in educating the public about the importance of correct mask use (covering mouth and nose) to prevent the spread of COVID-19.

 It is important to emphasize that masks work along with social distancing (staying at least 6 feet away from others) and frequent handwashing.

 As the holiday season approaches, it is vital to continue these measures to prevent serious COVID-19 illness and death.

https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html

. Updated October 5, 2020. Accessed October 26, 2020.

Johns Hopkins University & Medicine. Coronavirus resource center.

Reiner RC, Barber RM, Collins JK, et al. IHME COVID-19 Forecasting Team.Modeling COVID-19 scenarios for the United States. 

. Published online October 23, 2020. doi: 10.1038/s41591-020-1132-9.

. Fauci says it might be time to mandate masks as COVID-19 surges across US. 

https://www.cnn.com/2020/10/23/health/fauci-covid-mask-mandate-bn/index.html

. Published October 23, 2020. Accessed October 26, 2020.

To prevent the spread of COVID-19 throughout the United States, universal mask wearing is critical.

Study: Universal Mask Wearing Could Save Nearly 130,000 US Lives from COVID-19 

A diet rich in flavan-3-ols, more commonly referred to as flavanols, includes food and beverages such as tea, apples, and berries. According to the European Prospective Investigation into Cancer (EPIC) Norfolk study published in 

, this type of diet may lower blood pressure, indicating its ability to support the maintenance of cardiovascular (CVD) health on a population scale.

Flavanols are a group of bioactive compounds that have demonstrated an ability to help vascular function in prior intervention studies. For this reason, the researchers were interested in investigating flavanols as dietary support in the prevention of CVD diseases due to a lack of reliable data from observational studies on the subject. They noted that such a lack may be in part because of the high variability in the flavanol content of food, making estimates of actual intake difficult without nutritional biomarkers.

The researchers assessed the biomarker-estimated flavanol intake of 25,618 citizens of Norfolk in the United Kingdom in relation to their blood pressure and other CVD risk markers, as well as longitudinal associations with CVD risk. However, the researchers strayed from common practice in studies of this kind by not relying on the reported diets of participants, and instead measured flavanol intake through nutritional biomarkers, such as indicators of dietary intake, metabolism, or nutritional status present in the blood.

"Previous studies of large populations have always relied on self-reported data to draw conclusions, but this is the first epidemiological study of this scale to objectively investigate the association between a specific bioactive compound and health,” said lead author Gunter Kuhnle, PhD, a professor of nutrition at the University of Reading, in a press release.

The results demonstrated that participants with the lowest 10% of flavanol intake and participants with the highest 10% of intake had a difference in blood pressure between 2 and 4 mmHg. Such significant changes in blood pressure are comparable to those with a Mediterranean diet or moderate salt reduction.

"What this study gives us is an objective finding about the association between flavanols—found in tea and some fruits—and blood pressure. This research confirms the results from previous dietary intervention studies and shows that the same results can be achieved with a habitual diet rich in flavanols. In the British diet, the main sources are tea, cocoa, apples and berries,” Kuhnle said.

Kuhnle explained that the methodology of the study was also of importance in their research.

“This is one of the largest ever studies to use nutritional biomarkers to investigate bioactive compounds. Using nutritional biomarkers to estimate intake of bioactive food compounds has long been seen as the gold standard for research, as it allows intake to be measured objectively. The development, validation and application of the biomarker was only possible because of the long-term commitment of all collaborators. In contrast to self-reported dietary data, nutritional biomarkers can address the huge variability in food composition. We can therefore confidently attribute the associations we observed to flavanol intake," Kuhnle said.

Following this study, researchers from the University of Reading; Cambridge University; University of California, Davis; and Mars, Incorporated assessed the data of the participants from the EPIC Norfolk study and observed that the greatest change in blood pressure due to diet was observed in participants with the highest blood pressure.

The researchers noted this finding suggests that an increase in flavanol intake among the general public could result in an overall reduction in CVD disease incidence.

"This study adds key insights to a growing body of evidence supporting the benefits of dietary flavanols in health and nutrition,” said Hagen Schroeter, PhD, chief science officer at Mars Edge, in a press release. “But, perhaps even more exciting was the opportunity to apply objective biomarkers of flavanol intake at a large scale. This enabled the team to avoid the significant limitations that come with past approaches which rely on estimating intake based on self-reported food consumption data and the shortcomings of current food composition databases."

Ottaviani JI, Britten A, Lucarelli D, et al. Biomarker-estimated flavan-3-ol intake is associated with lower blood pressure in cross-sectional analysis in EPIC Norfolk. 

. 10,17964(2020). doi: 10.1038/s41598-020-74863-7.

High flavanol diet may lead to lower blood pressure. Reading, UK: University of Reading; October 21, 2020. eurekalert.org/pub_releases/2020-10/uor-hfd101620.php. Accessed October 28, 2020.

According to a recent study, a flavanol-rich diet may lower blood pressure, indicating its ability to support the maintenance of cardiovascular (CVD) health on a population scale.

Flavanol-rich Diet May Lower Blood Pressure

The FDA has approved invermectin 0.5% (Sklice, Sanofi Pasteur Inc), a lotion for the treatment of head lice, for OTC use.

Invermectin 0.5% was initially approved for prescription use in patients 6 months of age and older in February 2012. Every year, an estimated 6 to 12 million cases of head lice infestation occurs in children 3 to 11 years of age, according to an FDA press release. Lice are most common among children in preschool, elementary school, and among members of a household in which children have lice.

The nonprescription designation was changed in a process known as prescription (RX)-to-OTC switch. This process is usually initiated by the manufacturer, which must prove that the drug is safe and effective when used as directed in the proposed labeling in order to be successful.

Invermectin 0.5% is a lotion for external use only and should be used on the scalp or dry hair in accordance with label instructions only. The lotion is not approved for any other use, according to the FDA.

“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” Theresa Michele, MD, acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Today’s approval expands access to another effective topical treatment for the thousands of people with head lice.”

The lotion will be marketed as a nonprescription drug and will no longer require a prescription drug. Those who are currently using a prescription version of the product should consult their health care professional, according to the FDA.

FDA Approves Lotion for Nonprescription Use to Treat Head Lice [News Release] October 27, 2020; White Oak, MD. 

https://www.fda.gov/news-events/press-announcements/fda-approves-lotion-nonprescription-use-treat-head-lice?utm_medium=email&utm_source=govdelivery

Invermectin 0.5% is a topical lotion available OTC to treat head lice. 

FDA Approves Invermectin Lotion for Head Lice 

A new study from researchers at the University of Maryland School of Medicine (UMSOM) found that hospitalized patients with coronavirus disease 2019 (COVID-19) who were taking a daily low-dose aspirin to protect against cardiovascular disease had a significantly lower risk of complications and death compared with those who were not taking aspirin.

Further, aspirin takers were less likely to be placed in the ICU or hooked up to a mechanical ventilator and were more likely to survive the infection compared with hospitalized patients who were not taking aspirin.

"This is a critical finding that needs to be confirmed through a randomized clinical trial," said study leader Jonathan Chow, MD, assistant professor of Anesthesiology at UMSOM in a press release. "If our finding is confirmed, it would make aspirin the first widely available, over-the-counter medication to reduce mortality in COVID-19 patients."

Chow and his colleagues went through medical records of 412 COVID-19 patients with an average age of 55 years who were hospitalized over the past few months due to complications of their infection. The patients were treated at the University of Maryland Medical Center in Baltimore and 3 other hospitals along the East Coast. Approximately one-quarter of the patients taking a daily low-dose aspirin before they were admitted or right after admission to manage their cardiovascular disease.

The researchers found aspirin use was associated with a 44% reduction in the risk of being put on a mechanical ventilator, a 43% decrease in the risk of ICU admission, and a 47% decrease in the risk of dying in the hospital compared with those who were not taking aspirin. The patients in the aspirin group did not experience a significant increase in adverse events, such as major bleeding while hospitalized, according to the study.

Several factors may have contributed to the patients’ prognosis, including age, gender, body mass index, race, hypertension, and diabetes, also accounting for heart disease, kidney disease, liver disease, and the use of beta blockers to control blood pressure.

Although physicians often recommend a daily low-dose aspirin for patients who have previously had a heart attack or stroke caused by a blood clot to prevent future blood clots, daily use can increase the risk of major bleeding or peptic ulcer disease, according to the study.

"We believe that the blood thinning effects of aspirin provides benefits for COVID-19 patients by preventing microclot formation," said study co-author Michael A. Mazzeffi, MD, associate professor of anesthesiology at UMSOM, in a press release. "Patients diagnosed with COVID-19 may want to consider taking a daily aspirin as long as they check with their doctor first.”

Further studies are needed to prove that aspirin use leads to better outcomes in COVID-19, but the evidence from this study suggests that patients may want to discuss with their physician whether it is safe for them to take aspirin to manage potentially prevent serious complications, according to the study authors.

New study: aspirin use reduces risk of death in hospitalized patients. EurekAlert! Published October 22, 2020. Accessed October 23, 2020.

Aspirin takers were less likely to be placed in the ICU or hooked up to a mechanical ventilator and were more likely to survive the infection compared with hospitalized patients who were not taking aspirin.

Study: Aspirin Use Reduces Risk of Death in Hospitalized COVID-19 Patients 

New research suggests that CBD can reduce inflammation and reduce the cytokine storm that causes lung damage and death in many patients with coronavirus disease 2019 (COVID-19).

Investigators at the Dental College of Georgia and Medical College of Georgia had previously found that CBD improves oxygen levels and reduces inflammation and physical lung damage in their model of adult respiratory distress syndrome (ARDS). In their new study, the team found that apelin levels significantly decrease during COVID-19, but that CBD quickly helps normalize those levels.

“CBD almost brought [apelin] back to a normal level,” said co-author Jack Yu, MD, in a press release.

COVID-19 enters human cells via the angiotensin-converting enzyme 2 (ACE2) receptor, which typically works with apelin to control blood pressure. The authors hypothesized that an upregulation of both ACE2 and apelin may be helpful in cardiovascular disease by decreasing blood pressure and increasing the heart’s ability to pump.

Similar to other diseases, however, the investigators said COVID-19 appears to upset the partnership between apelin and ACE2. The binding of the virus to ACE2 has been shown to decrease the receptor’s levels and increase levels of angiotensin II, because angiotensin II is degraded and fewer vasodilators are produced.

In the researchers’ ARDS models, blood levels of apelin dropped close to zero but quickly increased 20 times over with CBD, according to the study published in the 

Journal of Cellular and Molecular Medicine.

 Apelin—a pervasive peptide created by cells in the heart, lungs, brain, fat tissue, and blood—is essential in regulating both blood pressure and inflammation.

When blood pressure increases, the investigators said apelin levels should grow in the correct place to help bring it down. It should also increase in order to normalize significant spikes in lung inflammation and related breathing difficulties associated with ARDS.

“Ideally, with ARDS it would increase in areas of the lungs where it’s needed to improve blood and oxygen flow to compensate and to protect,” said Babak Baban, PhD, the study’s corresponding author.

However, Baban added that this did not prove to be true in their ARDS model, with apelin decreasing in both the lung tissue itself and the general circulation.

Although the investigators did not attribute all of CBD’s benefits to apelin levels, they said the peptide does play an important role. More research is needed in order to understand whether COVID-19 or CBD have a direct impact on apelin or if these are downstream consequences.

“It is an association; we don’t know yet about causative, but it is a very good indicator of the disease,” Baban said.

CBD helps reduce lung damage from COVID by increasing levels of protective peptide [news release]. EurekAlert!; October 19, 2020. 

https://www.eurekalert.org/pub_releases/2020-10/mcog-chr101620.php

Although the investigators did not attribute all of CBD’s benefits to apelin levels, they said the peptide does play an important role.

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