FDA claims cough medicine news coverage is premature
WASHINGTON Recent news that the Food and Drug Administration has made decisions regarding the sale of pediatric cough and cold medicines have been premature, according to press statements issued by both the FDA and the Consumer Healthcare Products Association earlier this week.
“Recent media reports have misstated the FDA’s position on the use of pediatric cough and cold medicines, and these inaccurate reports may unnecessarily alarm and confuse parents who have successfully relied on these medicines to relieve the cough and cold symptoms in their children for generations,” stated CHPA president Linday Suydam on Tuesday. “FDA has not called for a ban on medicines for children under 6. Rather, the agency has presented a variety of internal and external recommendations for discussion at [an] upcoming advisory committee meeting,” she said. The meeting Suydam referenced is to take place Oct. 18 and 19.
“The Agency has not reached any final decisions as to actions to be taken in response to a Citizen Petition that requested FDA address the use of … products in children less than 6,” the FDA stated on Monday. “Any review document included in this package [that was posted online] that contains specific recommendations should not be considered final decisions by the agency. After hearing the recommendations of the advisory committee, FDA will determine the course of action.”
Current pediatric labels advise parents to ask a doctor about use of antihistamines for children under 6 years of age. Professional labeling for children between 2 and 6 years of age is available to health providers for the antihistamines. Other products containing decongestants, antitussives (cough suppressants) or expectorants are not labeled for children less than 2 years of age.
“Based on our commitment to the health and wellbeing of our nation’s families, and because children under age 2 are most vulnerable to misuse of over-the-counter cough and cold medicines, we are recommending that labeling for children under 2 be strengthened to read, ‘Do Not Use’ versus ‘Ask a Doctor.’ We also are recommending that language be added to the label of OTC antihistamines to read, ‘Do not use to sedate children,’” Suydam said. “In the coming months, we’ll be launching a major educational campaign alerting parents and caregivers to use great caution when administering medicines to children. Specifically, we will target parents and caregivers of children under two, as well as pediatricians, to further underscore that over-the-counter medicines should not be given to children under two.
NatExpo East enjoys record numbers
NEW YORK Natural Products Expo East last week posted 7 percent growth in overall attendance this year with more than 25,000 attendees and 1,790 exhibits, the organization announced Tuesday.
“The record-breaking success of this show reflects the escalating economic clout of natural, organic and healthy products,” stated Fred Linder, president of New Hope Natural Media.
With the natural and organic products industry growing at 9.7 percent annually and topping more than $56 billion in consumer sales, according to The Natural Foods Merchandiser’s 2007 Market Overview, Natural Products Expo East benefited from national trends toward healthier lifestyle choices across multiple channels of trade, including food and pharmacy.
Winners of the 2007 New Products Showcase Awards were: BeeCeuticals Organics Bee-Yond Body Rub (Personal Care/Health & Beauty); FoodShouldTasteGood MultiGrain Tortilla Chips and Manitoba Harvest Hemp Foods & Oils Organic Hempmilk (Food – tie); Nelsons Rescue Remedy Pastilles (Supplement/Herbs); Sweetriot 100 percent Dark Chocolate Cacao Nibs (Green/Environmentally-friendly); Wise-Acre Frost Teas (Innovation); and Zhena Gypsy Tea (Packaging).
Natural Products Expo East will relocate to Boston in 2008. Scheduled for October 15-18 at the Boston Convention and Exhibition Center, the move accommodates the industry’s growth, the organization noted.
Innovia introduces first home-use ear infection monitor
LENEXA, Kan. Innovia Medical on Tuesday launched EarCheck Middle Ear Monitor, the first clinically proven, physician-recommended, home-use device that accurately detects the presence of middle ear fluid, a key sign of a middle ear infection.
While EarCheck is for home use, it is based on the same patented and proven technology, acoustic reflectometry (or sound waves), used in doctor’s offices since 1997 and included in the American Academy of Pediatrics’ and American Academy of Family Physicians’ Clinical Practice Guideline for the Diagnosis and Management of Acute Otitis Media (middle ear infection), the company stated.
EarCheck works by sending a pleasant chirping sound into the ear canal. Some of this sound bounces off the eardrum and travels back to the instrument’s built-in processor. EarCheck then analyzes the reflected sound to determine if there is fluid in the middle ear.
The presence of fluid is represented by a 1-5 scale on an easy-to-read color display, where level 1 (Green) indicates Fluid/Ear Infection Unlikely and where levels 3-5 (Red) indicates a high Likelihood of Fluid/Ear Infection and suggests you consult with your child’s healthcare professional.
The device was developed because more than 80 percent of children under the age of three have had one or more ear infections, and nearly 50 percent have had three or more. While an infection can develop anytime, the majority occur during the cough/cold season, from October through March, when fluid lingering in the ear after a cold or flu becomes infected with either bacteria or virus.
The EarCheck Middle Ear Monitor is currently available at Wal-Mart and Babies “R” US or through one of the many online retailers that can be located from EarCheck’s website, www.earcheck.com. EarCheck’s suggested retail price is as high as $59.