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
3/13 - 16
2/6/2014 - posted
3/13 - 16
button coupons

Stock Report

1 DOW 18,030.21
+6.04 (0.03%)    
2 S&P 2,081.88
-0.29 (-0.01%)    
3 NASDAQ 4,773.47
+8.05 (0.17%)    
2/6/2014 - posted
3/13 - 16
2/6/2014 - posted
3/13 - 16
button classifieds
2/6/2014 - posted
3/13 - 16

Most Read This Week

December 24, 2014 10124

Christmas Eve Bloody Brawl Erupts on Dulin Street

in Local (Hopkins) Top News by Doreen Dennis
December 19, 2014 6144

Armstrong Mine to Layoff 39 by End of Day

in Top News For All Sites by Rita Dukes Smith, SurfKY News Director
December 19, 2014 5229

Dawson Springs Man Charged with Sexual Abuse of…

in Local (Hopkins) Top News by Detective Sean McCance
December 19, 2014 4698

Woman Flown to St. Mary's after Two-Car Collision

in Local (Hopkins) Top News by Trooper Stu Recke
December 19, 2014 3933

Vehicle Fire Causes Traffic Back-Up on Pennyrile

in Local (Hopkins) Top News by Doreen Dennis
December 23, 2014 3792

Couple's Alleged Dispute over Blanket Leads to…

in Local (Hopkins) Top News by Madisonville Police Department
December 19, 2014 3648

Vehicle Explodes into Flames on Pride Avenue

in Local (Hopkins) Top News by Gwen Smith
December 23, 2014 3254

Alleged Theft at Walmart Sends Two to Jail

in Local (Hopkins) Top News by Madisonville Police Department
December 22, 2014 3158

Madisonville Police Arrest Reports - Dec. 22, 2014

in Hopkins News by Madisonville Police Department
December 20, 2014 2986

KET’s Kentucky Life Segment to Feature Old…

in Local (Muhlenberg) Top News by Paul McRee, SurfKY News

Stories Trending Today

December 24, 2014 10124

Christmas Eve Bloody Brawl Erupts on Dulin Street

in Local (Hopkins) Top News by Doreen Dennis
December 23, 2014 2704

Disturbance Results in Vehicle, Foot Pursuit,…

in Local (Hopkins) Top News by Officer Tyler Russell
December 23, 2014 2420

Hopkins County Grand Jury Indictments

in Local (Hopkins) Top News by Karen McKnight
December 24, 2014 1503

KCC Hosts 'Gift of Life' Opportunity

in Top News For All Sites Touching Hopkins by Tammy Holloway, SurfKY News
December 24, 2014 1463

'Frozen' Plays to One Last Packed House at Living…

in Local (Muhlenberg) Top News by Paul McRee, SurfKY News
December 24, 2014 1438

2014 Looking Back: World Saddened at Death of…

in Top News For All Sites by Paul McRee, SurfKY News
December 24, 2014 1375

Statewide Broadband Initiative Launched

in Top News For All Sites by Office of the Governor
December 24, 2014 1268

True Gift of Christmas Trumps Evil by Richard…

in Top News For All Sites by Richard Nelson
December 24, 2014 1092

How to Avoid Post-Holiday Shopping Crowds

in General News For All Sites by SurfKY News
December 24, 2014 1041

Holiday Waste by the Numbers

in General News For All Sites by SurfKY News

SurfKY News Group, Inc.
Corporate Office & Studio
1125 Nebo Rd.  •  Madisonville, KY 42431
270.452.2727 (phone)
  •  270.452.2249 (fax)


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

social fbsocial twsocial yt
social gpsocial flrsocial rss