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FDA hearing on kids’ cold medicines spells greater confusion for parents

Nationally recognized pediatrician Dr. Jennifer Shu offers tips and drug-free options to help children breathe better when they are sick

Parsippany, NJ, October 7, 2008 – The FDA’s decision to hold a hearing about the safety, efficacy and use of cold and cough medications by children may leave parents with questions about how to safely treat a child who is suffering from nasal congestion.  Since children get an average of six to ten colds per year, each lasting anywhere from one to two weeks, it is important that parents are aware of safe, drug-free alternatives for children's nasal congestion that can help children breathe better without unwanted side effects.

The recent FDA hearing highlighted a significant need for further investigation of the efficacy of over-the-counter kids’ cough and cold medicines, and stems from January’s recommendation to discontinue the use of the OTC drugs to treat infants and children under two years of age.  As part of the ongoing hearings, the FDA is assessing the proper use of these products in the population of children 12 years of age and under and is considering limiting their availability. 

“With the recent news and FDA hearings on children’s cough/cold medicines, parents may be feeling a sense of confusion when it comes to treating their children suffering from nasal congestion," said Dr. Jennifer Shu, nationally recognized pediatrician, mom and co-author of award-winning parenting books published by the American Academy of Pediatrics.  "Drug-free remedies, such as new Breathe Right Kids nasal strips provide nasal congestion relief that helps children breathe better so they can sleep better and are a great alternative to over-the-counter pediatric cold medications for nasal congestion.  As a drug-free option, parents do not have to worry about unwanted side effects – something that gives me peace of mind when treating my own child.” 

Breathe Right Kids nasal strips are now available and are specifically designed to fit small noses to help open a child’s nasal passages to instantly relieve congestion.  Each drug-free, non-prescription nasal strip consists of a flexible "spring-like" band placed across the bridge of the nose.  Breathe Right Kids nasal strips are comfortable to wear, can be worn overnight and are gentle for a child's delicate skin.

Additionally, a recent study in healthy children shows that Breathe Right Kids nasal strips help children breathe better by improving airflow when lying down to go to sleep.  Findings also indicate that the strips are well-tolerated by children, comfortable to wear and easy to remove. 

Dr. Shu also recommends keeping the old stand-by remedies on the list of things to try for an ailing child, including rest, drinking plenty of fluids, eating chicken soup and taking over-the-counter fever reducers as needed. 

"Other simple drug-free remedies such as humidifiers or vaporizers, and Breathe Right Kids nasal strips all stand to provide nasal congestion relief while giving parents an alternative to over-the-counter cold medications for nasal congestion," said Dr. Shu. "But when it comes to the common cold, it’s important to remember that an ounce of prevention is worth a pound of cure.  Parents should remind children to wash hands frequently or use a hand sanitizer to avoid germs that can cause illness in the first place."

Research from the CDC shows more than 7,000 children ages 11 and younger head to the emergency room each year due to the misuse of cough/cold medicines.  Additionally, a recent study by the Consumer Healthcare Products Association showed that a quarter of parents would use adult medicine and adjust the dose to treat their child if pediatric cough/cold products were no longer available without a prescription.  This practice may result in dosing strengths that are inappropriate and potentially harmful for children.

For more information about new Breathe Right Nasal Strips for Kids, please visit www.breatheright.com.

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world’s largest over-the-counter consumer healthcare products companies.  Its more than 30 well-known brands include the leading smoking cessation products, Nicorette^® and NicoDerm^®, as well as many medicine cabinet staples, alli^®, Aquafresh^®, Sensodyne^®, and TUMS^®, which are trademarks owned by and/or licensed to GlaxoSmithKline Group of Companies.

About GlaxoSmithKline

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For company information visit: http://www.gsk.com.