The Food and Drug Administration (FDA) announced the emergency use authorization for the antiviral drug remdesivir, after preliminary results from a federal trial showed the drug could speed recovery in patients infected with the coronavirus. The finding, which has not yet been peer reviewed, came after another study found no benefit for the drug in severely ill patients in China. The new results suggest a moderate improvement in the death rate of patients taking remdesivir, whose hospital stays were shortened, on average, from 15 days to 11.
The issuance of an EUA is different than FDA approval. In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks of any unproven products with any known or potential benefits of making them available during the emergency. Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.
The emergency use authorization (EUA) allows for remdesivir to be distributed in the U.S. and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.
The EUA requires that fact sheets that provide important information about using remdesivir in treating COVID-19 be made available to health care providers and patients, including dosing instructions, potential side effects and drug interactions. The EUA is temporary and will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. It may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
Possible side effects of remdesivir include increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering.
The top coronavirus task force scientist Dr. Anthony Fauci welcomed news of the first potential treatment for COVID-19. The U.S. government will coordinate the donation and distribution of remdesivir to hospitals in cities most heavily impacted by COVID-19. Given the severity of illness of patients appropriate for remdesivir treatment and the limited availability of drug supply, hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution of remdesivir.
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In an effort to broaden the company’s “social interaction” with our clients and FaceBook fans, Daily Trivia Questions are posted on both of our business pages. Here are the weekly standings for this past week, and the winner of the Sunday night Weekly Drawing for an AmEx gift card!
Congratulations – To this past week’s Trivia Contest Winner!! Our latest contest winner for the weekly FaceBook HealthInsurance4Everyone/Health & Life Solutions, LLC Trivia Contest, drawn randomly by computer late Sunday evening, February 12th, 2017 was:
BRITTANY MICHELLE
Archdale, NC
Winner Of A $25.00 AmEx Gift Card
Each day, fans of either of our company FaceBook pages (HealthInsurance4Everyone or Health & Life Solutions LLC) are able to test their skills with our Daily TRIVIA QUESTION. The first 20 winners who post the correct answer to the TRIVIA QUESTION, will then get entered into the weekly drawing held late on Sunday evenings for a $25.00 Am Ex Gift. Card
Weekly Gift Card winners will be posted in our blog at this site. Remember to become a FaceBook “fan” on either of our company pages to enter and post your answers.
Here are the daily contestants from last week’s Trivia Contest that were entered into the Sunday drawing:
2/6/17
Christine Acoba
Crystal Young
Ashley Nichole Busse
Kristina Harris
Autumn Dansby
Jamie Shapiro
Sandy Nevels
Sherri Kidwell
Kristen Raia Bowman
Sheila Vives
Heather Marie Stacy
Andrea Timms
Phylicia Phillips
Erin Leigh Will
Lotorya Patrick
Alexandra Vindiola
Deborah Farris
Shawna Poole
Eva Biggs
Tiffany Banks
2/7/17
Christine Acoba
Beth Cleveland
Mya Murphy
Brandi Kerr
Tessa Davis
Lisa Puckett
Carla S-Paige Williams
Joanie Waterman
Preeti Chand
Tina Marie
Sherri Kidwell
Marcy Coull
Valerie Kuehn
Kayla Hernandez
Nai Merri
Andrea Timms
Heather Jacques
Jennifer Downing
Alisa Jones
Priscilla Shimp
2/8/17
Christine Acoba
Valerie Kuehn
Jennifer Downing
Nai Merri
Anna Nichols
Nitasha Shank
Isis Sample
Amy Marie Wilkinson
Cheyenne Shaw
Mya Murphy
Fanny Wat
Andrea Timms
Jacqlyn Gummert
Traci Anderson
Ashley Stamey Phillips
Tabitha Sinks
Deborah Farris
Cassandra Berholtz
Chelcie Malow
Alicia Dansby
2/9/17
Christy Hawkes
Valerie Kuehn
Jonnalyn Gates
Megan Rhyne
Sheila Carvell
Jade Good
Anna Ashley Pinder
Kelly Prestenbach
Katrina Worford
Kim Floyd
Preeti Chand
Geri Rus
Roberta Thomas
Lisa David Carr
Darrell Ashley Street
Becky Freeman
Karen Bondehagen
Adaria Johnson
Wendi Black
Brittany Michelle
2/10/17
Jennifer Alice Duran
Lori Capobianco
Brittany Deaver
Jennifer Ramlet
Valerie Kuehn
Megan Rhyne
Rhonda Nicholson
Sandy Nevels
Brandy Marie Williams
Poonam Gosain
Jade Good
Dean Bruss
Poonam Gosain
Samantha Brwn Ramos
Lisa David Carr
Roberta Thomas
Ashley Stamey Phillips
Tammy Alcorta
Angela Nicole
Susanne Killion
Muneca Muneca
Tessa Davis
2/11/17
Hollie Jahnke
Holly Cajigas
Nai Merri
Kimberly Taylor Hall
Tina Marie
Jodi Stevens
Ashley Stamey Phillips
Karen Bondehagen
Alexandria Fields
Phyllis Hines
Rebecca Fauteux
Amy Hopper
Sheila Carvell
Jessica Miller
Kellie Lacy
Tina Casto-Shafer
Mary Achio
Christina Radcliff
Melissa Turner Baker
Heather Jacques
2/12/17
Kendra George
Christine Acoba
Amy Chavis
Anna Nichols
Glenna Zanaglio
Mary Achio
Lotorya Patrick
Mary Ann Cody
Angela Nicole
Dale Fish
Holly Cajigas
Darbie Brown
Dean Bruss
Emily Rice Bowersock
Lori Marie Timms
Brenda Casey
Christine McKinnon
Mike Adamski
Jane Peterson
Jennifer Downing
Crystal Hazelwood
Be sure to watch both of our FaceBook pages for your chance to win and enter again next week, with questions posted daily on HealthInsurance4Everyone or at Health & Life Solutions, LLC!!
Remember that if you try your hand at answering the Trivia Question several days each week, your odds of winning the Sunday weekly drawing are much better. You may also find that if you “Like” both of the business pages, you will receive faster notifications of the other players as they post their answers to compete with you!
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At Health Insurance 4 Everyone, we not only want to improve our customer service but also interact with our customers on a social media level that wasn’t available before. Interested in connecting with us? Look us up on….
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