Pick Your Community: | Hopkins | Muhlenberg | Daviess | Christian | Henderson | Lakes | McCracken | Webster
Davis Motor Sales banner ad

FDA Approves Ragwitek for Short Ragweed Pollen Allergies

spring-allergiesKENTUCKY (4/17/14) — The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.

Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves. Treatment with Ragwitek is started 12 weeks before the start of ragweed pollen season and continued throughout the season. The first dose is taken in a health care professional’s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek at home.

“The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Individuals with allergic rhinitis with or without conjunctivitis may experience a runny nose, repetitive sneezing, nasal itching, nasal congestion, and itchy and watery eyes. Short ragweed pollen is one of the most common seasonal allergens and is prevalent during the late summer and early fall months in most of the United States. Short ragweed pollen induced allergies are generally managed by avoiding the allergen, medications to relieve symptoms, or with allergy shots.

The safety and effectiveness of Ragwitek was evaluated in studies conducted in the United States and internationally. Safety was assessed in approximately 1,700 adults. The most commonly reported adverse reactions by patients treated with Ragwitek were itching in the mouth and ears and throat irritation. Of the 1,700 adults, about 760 were evaluated to determine effectiveness. Some patients received Ragwitek; others received an inactive substitute (placebo). The patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for one ragweed pollen season, patients who received Ragwitek experienced approximately a 26 percent reduction in symptoms and the need for medications compared to those who received a placebo.

The Prescribing Information includes a boxed warning to inform that severe allergic reactions, some of which can be life threatening, can occur. Ragwitek also has a Medication Guide for distribution to the patient.

Ragwitek is manufactured for Merck, Sharp & Dohme Corp., (a subsidiary of Merck and Co., Inc., Whitehouse Station, N.J.) by Catalent Pharma Solutions Limited, United Kingdom. For more information: Allergenics.

Read more on SurfKY about allergies:

Spring Allergies May Come From Everyday Things

Scoping It Out: Spring is Here, Do You Have the Fever?

SurfKY News
Information provided by FDA

© Copyright 2014 SurfKY News Group, Inc. All rights reserved. This material may not be published, broadcast, or rewritten without permission. SurfKY News encourages you to share this story by using one of the social media links below.

Posted on 2/2/14

Latest Video

Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
2/6/2014 - posted
3/13 - 16
Started 11/8/2013
Started 11/8/2013

Stock Report

1 DOW 17,071.22
-41.93 (-0.25%)    
2 S&P 1,977.80
-5.05 (-0.25%)    
3 NASDAQ 4,505.85
-6.34 (-0.14%)    
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
2/6/2014 - posted
3/13 - 16
Started 11/8/2013
Started 11/8/2013
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
2/6/2014 - posted
3/13 - 16
Started 11/8/2013
Started 11/8/2013
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
Genovese - http://www.mchky.org/staff/bio.php?doc_id=35646&sub= Lewis - http://www.mchky.org/getpage.php?name=bracken_lewis Holt - http://www.mchky.org/getpage.php?name=drholt Napier - http://www.mchky.org/getpage.php?name=dr.napier_page Newman - http://www.mchky.org/staff/bio.php?doc_id=50353
2/6/2014 - posted
3/13 - 16
Started 11/8/2013
Started 11/8/2013

Most Read This Week (Site-Wide)

September 26, 2014 5319

Super Walmart Headed to Hanson, Fate of…

in Top Stories by Amber Averitt, SurfKY News
September 24, 2014 4374

Grapevine Road Collision Results in One Fatality,…

in Top Stories by Information provided by Trooper Stu Recke
September 25, 2014 4044

Hopkins County Grand Jury Indictments

in News by Karen McKnight
September 27, 2014 3259

Hopkins County Grand Jury Misdemeanor Indictments

in News by Karen McKnight
September 26, 2014 3145

Drug Sting Results in Meth Trafficking Charge

in Top Stories by Madisonville Police Department
September 29, 2014 2843

Endless Road Strings Bring Orchestra Mix to…

in Top Stories by Paul McRee, SurfKY News
September 25, 2014 2830

Ace Squared Offering Free GED Classes

in Top Stories by Charles W. Riley II, SurfKY News
September 25, 2014 2819

Muhlenberg Community Hospital to Host Lighting of…

in Top Stories by Information provided by Erin Warren
September 25, 2014 2653

Madisonville Police Arrest Reports - Sept. 25,…

in News by Madisonville Police Department
September 25, 2014 2219

Police Arrest Man for Public Intoxication Three…

in Top Stories by Madisonville Police Department
September 25, 2014 2132

Shoplifting Complaint Leads to Resisting Arrest,…

in Top Stories by Information provided by MPD

Most Read Stories from Hopkins County

September 24, 2014 4374

Grapevine Road Collision Results in One…

in Top Stories by Information provided by Trooper Stu Recke
September 26, 2014 3145

Drug Sting Results in Meth Trafficking…

in Top Stories by Madisonville Police Department
September 25, 2014 2219

Police Arrest Man for Public Intoxication…

in Top Stories by Madisonville Police Department
September 25, 2014 2132

Shoplifting Complaint Leads to Resisting…

in Top Stories by Information provided by MPD
September 29, 2014 1512

Man, Woman Charged with Violating EPO…

in Top Stories by Madisonville Police Department

Most Read Stories from Muhlenberg County

September 29, 2014 2843

Endless Road Strings Bring Orchestra Mix…

in Top Stories by Paul McRee, SurfKY News
September 25, 2014 2830

Ace Squared Offering Free GED Classes

in Top Stories by Charles W. Riley II, SurfKY News
September 25, 2014 2819

Muhlenberg Community Hospital to Host…

in Top Stories by Information provided by Erin Warren
September 26, 2014 1971

Muhlenberg Job Corps Recognizes Employee…

in Top Stories by Karen Robinson
September 26, 2014 1950

Muhlenberg 911 Service Recipient of…

in Top Stories by Rebecca Hanchett

SurfKY News Group, Inc. Central Office & Printing Division
1125 Nebo Rd.  •  Madisonville, KY 42431  •  270.452.2249 (fax)
Main Number: 270.452.2727 (phone)  •  Printing Division Direct Line: 270.821.8600 (phone)


Contact a member of our staff: www.surfky.com/contact
Copyright © 2014 SurfKY News Group, Inc.  •  Terms of Use  •  Site Map

social 03social 04social 22social 21social 06