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Pediatric segment of cough/cold markets still in flux.

NEW YORK--Over-the-counter medicines have long been the front line of defense for parents coping with colds and flu in their children. Although O-T-C products have been available and used safely for decades, instances of misusage have fueled controversy and prompted some critics, including some medical professionals, to question their efficacy and recommend against their use.

Contributing to negative perceptions in recent years was the massive 201 0 recall of 43 pediatric O-T-Cs by McNeil Consumer Healthcare, a division of Johnson and Johnson. The recall followed an inspection of a McNeil plant by the Food and Drug Administration that uncovered deficiencies in the manufacturing processes. The recall was implemented even though an FDA commissioner described the possibility of serious health problems resulting from use of the medicines as remote.

The recalled products, which included children's versions of Tylenol, Motrin and Benadryl, have since returned to store shelves and sales, propelled by a heavy marketing investment from 1811, are soaring. According to data from SymphonyIRI Group Inc., sales of liquid internal analgesics during the 12 weeks ended December 30 soared nearly 21% to $101.5 million. The biggest gains were posted by McNeil's Children's Tylenol, which became the leading brand on the strength of a 60% dollar increase; No. 3 Children's Motrin; and Infant's Motrin, which moved into the sixth rank.

Other brands performed well, too: Pfizer Consumer Healthcare's Infant's Advil took the No. 5 spot with a 28% sales increase, while Little Fevers from Prestige Brands International Inc. reported a dollar gain of nearly 22% that propelled the brand into seventh place.

Like other categories, cough/cold benefits from product innovation. Although it is not a segment that has been associated with external analgesics, Wellco Brands, a new company focused on creating unique products for the entire family, has introduced Healerz For Noses, a pain relief cream developed to soothe the delicate skin under the nose that can become irritated from colds and allergies. According to the company, there are no other products at retail indicated for this use.

Healerz For Noses is formulated with lidocaine for pain relief, benzalkonium chloride antiseptic to ward off infection and aloe for its soothing properties. It is specially packaged in six single-use packets that can easily be carried on the go.

In recent years manufacturers have moved to allay safety concerns by revising the labels of their pediatric cough-cold medicines to encourage and facilitate their proper use. For example, O-T-Cs that contain antihistamines now carry a warning against using them to sedate children or make them sleepy. Dosing instructions for children ages four and older have not changed, but labels now advise parents and caregivers not to use them for children under the age of four.

Nevertheless, O-T-C cough-cold remedies remain somewhat controversial. The American Academy of Pediatrics (MP), for example, recommends that O-T-C cough-cold remedies not be given to infants or small children and contends that they have not been proven effective. Instead, the AAP recommends other methods to treat cold symptoms, such as saline nasal sprays or drops and suction bulbs to remove mucus from the nose.

However, O-T-C children's liquid analgesics clearly remain the most popular and convenient way to combat fever and headaches or body aches associated with flu. The primary analgesics, acetaminophen (used in Tylenol) and ibuprofen (the active ingredient in Advil and Motrin), are both long-proven to be effective in treating pain and fever in children and adults.

The key to safe and effective use of these medicines, as emphasized by the Consumer Healthcare Products Association (CHPA), is to follow dosing instructions on the label and, if necessary, ask one's doctor about proper dosage for a child of a given age and weight. Parents should also take care to avoid double dosing by giving their child more than one medicine with the same active ingredient. Finally, all medicines should be stored out of children's sight and reach.

A very different kind of safety issue has surrounded misuse of O-T-C cough medicines by teenagers seeking a drug high. The CHPA has been aggressive in partnering with other organizations, such as the Community Anti-Drug Coalitions of America (CADCA), to raise parents' awareness of potential for such abuse.
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Title Annotation:Cough/Cold/O-T-C
Date:Feb 11, 2013
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