Navigation Links
Statement from the Consumer Healthcare Products Association on Today's Joint FDA Advisory Committee Recommendations Regarding Pediatric Over-the-Counter Cough and Cold Medicines
Date:10/19/2007

WASHINGTON, Oct. 19 /PRNewswire-USNewswire/ -- Following is a statement by Linda A. Suydam, D.P.A., president of the Consumer Healthcare Products Association (CHPA), regarding the recommendations issued today by the U.S. Food and Drug Administration's Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee. At a meeting this week, the joint committee addressed the use of over-the-counter cough and cold medicines in children.

"For decades, parents and other caregivers have relied upon and trusted pediatric cough and cold medicines to relieve symptoms of the common cold in children and provide real comfort to children with runny noses, congestion and coughs.

"We believe that some of today's advisory committee recommendations support and confirm the risk-management efforts we have proposed. However, other recommendations -- notably the split vote to make single active ingredients no longer available for use in children under six years old -- if adopted by FDA, would unduly limit parents' access to medicines that work and are safe when taken as directed. The committee's split majority vote on this matter clearly did not reflect a consensus of opinion, and we hope the FDA will weigh this recommendation with great caution. Adoption of this recommendation would leave parents with no over-the-counter medicinal relief when their children are suffering from cold symptoms.

"The data clearly show that these medicines are very safe when used as directed and that harm to this age group, while very rare, is attributable in most cases to accidental ingestion -- an issue of safekeeping that is best addressed through education.

"Over-the-counter cough and cold medicines with multiple ingredients play an important role in relieving suffering from the common cold. It is easier and more practical to treat a child with a multiple symptom relief product. And the data presented at the advisory committee meeting show that multiple-ingredient products are as safe if not even less susceptible to misuse.

"Today, the advisory committee decided that there was insufficient evidence in pediatric populations to support efficacy. This is an issue we will address with FDA. We are already planning pharmacokinetic studies in children, which are the first step toward confirming correct dosing, and we will work with FDA to design appropriate pediatric clinical efficacy studies."

CHPA is the 126-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplement products.

http://www.chpa-info.org


'/>"/>
SOURCE Consumer Healthcare Products Association
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Paracetamol May Cause Live Damage Warns Consumer Education and Research Centre
2. Iodex goes to SmithKline Beecham consumer Healthcare
3. Consumer group seeks Sibutramine ban
4. Identifying What Consumers Look For On Food Stuff Labels
5. Consumers Becoming More Health Conscious Than Calorie Conscious
6. With More Appearance Conscious Consumers The Need For Slimming Products Is Rapidly Rising
7. Consumers of soft drinks to be more alert
8. Consumers Worried About Trans-Fats The Most
9. New Plastic Surgery Unit Set Up In Kolkata To Meet Ever-Increasing Consumer Demand
10. Health care system “Consumer friendly” by 207
11. Chocolate makers to be health wise and urge consumers to be too!
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/24/2017)... ... April 24, 2017 , ... Salus ... announces the company’s VideoMedicine mobile platform has launched Quick Care, a new service ... day, Quick Care provides patients with the option to request and begin a ...
(Date:4/24/2017)... IL (PRWEB) , ... April 24, 2017 , ... Rod ... the Senior Housing News website. , Rod has been at the forefront of Gardant ... company’s culture. As CEO, Rod has overseen the opening of more than 40 new ...
(Date:4/24/2017)... ... , ... Donna Parker, L. Ac. reads all sorts of books on ... be very practical. She wanted to write a guide/workbook that would give readers step-by-step ... prompted her in writing “ A Clear Path to a Vibrant Life : 7 ...
(Date:4/24/2017)... ... April 24, 2017 , ... Miami ... attending the 2017 Oral Reconstruction Foundation’s 2017 Symposium on Tissue Regeneration and Implant ... will present its annual Global Symposium at the Fontainebleau Hotel located in Miami ...
(Date:4/23/2017)... ... April 23, 2017 , ... "An event Horizon is ... the process rendered in my Art and Music. These are created as Metaphysical Transformations ... the boundary of mystery culminate to the ultimate singularity.", -- Karen Salicath Jamali , ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... Companion animal vaccines ... pets such as canine, avian and feline. ... such as Attenuated Live Vaccines, Conjugate Vaccines, Inactivated ... Recombinant Vaccines. Attenuated live vaccines are derived from ... have been weakend under laboratory conditions. Conjugate vaccines ...
(Date:4/18/2017)... , April 18, 2017 Cogentix Medical, Inc. ... providing the Urology, Uro/Gyn and Gynecology markets with innovative ... first quarter ended March 31, 2017 after the market ... The Company will host a conference call and webcast ... Tuesday, May 2, 2017 at 4:30 p.m. Eastern Time ...
(Date:4/18/2017)... SUNNYVALE, Calif. , April 18, 2017 /PRNewswire/ ... results of collaboration started in 2016, in which ... "Artificial Brain SOINN". The companies achieved initial results ... ultrasound solution by Artificial Brain SOINN. The results ... Tokyo Big Sight, April 19-21, at booths 4505 ...
Breaking Medicine Technology: