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FDA Cites Dosing Errors in New Recommendations for Children's OTC Medications

Friday, October 17, 2008 General News
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PALM BEACH GARDENS, Fla., Oct. 16 Underscoring theimportance of weight-based dosing for over-the-counter (OTC) children'smedications, the Food and Drug Administration (FDA) recently announced itsrecommendation that cold and cough medications be relabeled: "For ChildrenAges 4 and Up."
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Emphasizing that dosing errors and accidental ingestions are the leadingcauses of adverse events in children related to cough and cold ingredients,OTC manufacturers voluntarily agreed to change the dosing directions,according to the Consumer Healthcare Production Association (CHPA).
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Dosing by age rather than weight is a core issue of the safety andefficacy of cough/cold products for children. Many pharmaceuticalmanufacturers state on their labels or Web sites, "If possible, dose byweight," but actually provide directions in wide age groups because there isnot enough room to provide dosing directions by specific weight. For example,the instructions for a popular cough medication has children in the 2 to 6 agegroup with weights ranging from 24 lbs. to 48 lbs., all receiving the samedose of medication. By weight-based dosing standards, only children weighingbetween 24 lbs. and 28 lbs. would achieve effective results. The remainderwould be under-dosed by 17%-50%.

"It has been my experience that when dosed correctly, over-the-countermedications work properly. But, when we under-dose, symptoms return before thenext scheduled dosing," said Brian Kaplan, M.D., a pediatrician and 20-yearemergency room physician who is used to seeing the result of inaccuratedosing. "I recommend weight-based dosing to all my patients and applaud thedirection the industry is taking. I'm pleased to see more health careprofessionals and caregivers focusing on the real problem - proper dosing."

To meet the need for safe and effective dosing, Dr. Kaplan spent sevenyears creating AccuDial, a patented, rotating labeling system that enablesprecise dosing of children's medications by weight.

AccuDial, Inc. has filed with Health Canada for approval to launch afamily of nine over-the-counter analgesic, allergy, cold, and coughmedications by mid-2009. The company is working on obtaining Food and DrugAdministration approvals in the United States, as well as internationalregulatory agencies for European distribution. The company's patented dosingsolution enables a caregiver to rotate the bottle's label and quickly find thecorrect dose based on a child's specific weight. Every AccuDial productincludes a dosing spoon that is calibrated to match the dosing directions.

The information contained in this press release include "forward-lookingstatements." All statements other than statements of historical facts includedin this press release, including the Company's prospects, plans, financialposition, and business strategy, may constitute forward-looking statements.These statements are based on the beliefs and assumptions of our managementand on the information currently available to our management at the time ofsuch statements. Forward-looking statements generally can be identified by thewords "believes," "expects," "anticipates," "intends," "plans," "estimates,"or similar expressions that indicate future events and trends. Although theCompany believes that the expectations reflected in these forward-lookingstatements are reasonable, the Company can give no assurance that theseexpectations will prove to be correct, and the Company's actual results maydiffer significantly from the results discussed in these forward-lookingstatements. The Company undertakes no obligation to publicly update or reviseany forward-looking statements, whether as the result of new information,future events, or otherwise. For more information on AccuDial, visitwww.accuratedose.com .

SOURCE AccuDial, Inc.
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