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FDA Hearing on Kids' Cold Medicines Spells Greater Confusion for Parents

Wednesday, October 8, 2008 General News J E 4
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PARSIPPANY, N.J., Oct. 7 The FDA's decision to hold ahearing about the safety, efficacy and use of cold and cough medications bychildren may leave parents with questions about how to safely treat a childwho is suffering from nasal congestion. Since children get an average of sixto ten colds per year, each lasting anywhere from one to two weeks, it isimportant that parents are aware of safe, drug-free alternatives forchildren's nasal congestion that can help children breathe better withoutunwanted side effects.

The recent FDA hearing highlighted a significant need for furtherinvestigation of the efficacy of over-the-counter kids' cough and coldmedicines, and stems from January's recommendation to discontinue the use ofthe OTC drugs to treat infants and children under two years of age. As partof the ongoing hearings, the FDA is assessing the proper use of these productsin the population of children 12 years of age and under and is consideringlimiting 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 theirchildren suffering from nasal congestion," said Dr. Jennifer Shu, nationallyrecognized pediatrician, mom and co-author of award-winning parenting bookspublished by the American Academy of Pediatrics. "Drug-free remedies, such asnew Breathe Right Kids nasal strips provide nasal congestion relief that helpschildren breathe better so they can sleep better and are a great alternativeto over-the-counter pediatric cold medications for nasal congestion. As adrug-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 specificallydesigned to fit small noses to help open a child's nasal passages to instantlyrelieve congestion. Each drug-free, non-prescription nasal strip consists ofa flexible "spring-like" band placed across the bridge of the nose. BreatheRight Kids nasal strips are comfortable to wear, can be worn overnight and aregentle for a child's delicate skin.

Additionally, a recent study in healthy children shows that Breathe RightKids nasal strips help children breathe better by improving airflow when lyingdown to go to sleep. Findings also indicate that the strips arewell-tolerated by children, comfortable to wear and easy to remove.

Dr. Shu also recommends keeping the old stand-by remedies on the list ofthings 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, andBreathe Right Kids nasal strips all stand to provide nasal congestion reliefwhile giving parents an alternative to over-the-counter cold medications fornasal congestion," said Dr. Shu. "But when it comes to the common cold, it'simportant to remember that an ounce of prevention is worth a pound of cure.Parents should remind children to wash hands frequently or use a handsanitizer to avoid germs that can cause illness in the first place."

Research from the CDC shows more than 7,000 children ages 11 and youngerhead to the emergency room each year due to the misuse of cough/coldmedicines. Additionally, a recent study by the Consumer Healthcare ProductsAssociation showed that a quarter of parents would use adult medicine andadjust the dose to treat their child if pediatric cough/cold products were nolonger available without a prescription. This practice may result in dosingstrengths that are inappropriate and potentially harmful for children.

For more information about new Breathe Right Nasal Strips for Kids, pleasevisit http://www.breatheright.com.

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world's largestover-the-counter consumer healthcare products companies. Its more than 30well-known brands include the leading smoking cessation products, Nicorette(R)and NicoDerm(R), as well as many medicine cabinet staples, alli(R),Aquafresh(R), Sensodyne(R), and TUMS(R), which are trademarks owned by and/orlicensed to GlaxoSmithKline Group of Companies.

About GlaxoSmithKline

GlaxoSmithKline -- one of the world's leading research-basedpharmaceutical and healthcare companies -- is committed to improving thequality of human life by enabling people to do more, feel better and livelonger. For company information visit: http://www.gsk.com.Contacts: Mark Polisky Debbie Bolding GolinHarris GlaxoSmithKline Consumer Healthcare 312.729.4417; cell: 773.330.2866 412.200.3872; cell: 412.523.4899 mpolisky@golinharris.com deborah.g.bolding@gsk.com

SOURCE GlaxoSmithKline Consumer Healthcare
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