PALM BEACH GARDENS, Fla., May 19, 2011 /PRNewswire/ -- Underscoring the importance of weight-based dosing for over-the-counter (OTC) children's acetaminophen medications, AccuDial Pharmaceutical, Inc. made seven recommendations to the Food & Drug Administration (FDA) at the meeting of the Joint Pediatric Advisory Committee and Non-Prescription Drugs Advisory Committee meeting on Tuesday, May 17, 2011 concerning children's single-ingredient acetaminophen products.
Bob Terwilliger, Chairman and CEO of AccuDial said, "AccuDial supports all recommendations made by the Consumer Healthcare Product Association (CHPA) to the Joint Advisory Committee. A majority of healthcare professional groups including the American Association of Pediatricians support the recommendations made by CHPA and AccuDial."
"Dosing by age is a core issue of the safety and efficacy of acetaminophen products for children," Terwilliger said. "Many pharmaceutical manufacturers and various FDA websites state, 'if possible, dose by weight.' Dosing instructions by age or weight ranges are very confusing for many parents. For example, when dosing by age or weight ranges, only the smallest or youngest child in each group receives 15 milligrams per kilogram, the optimal dose. The remainder are under-dosed by 17-50% depending on where they fall in the age or weight ranges," said Terwilliger.
AccuDial Pharmaceutical is an OTC children's medication manufacturer whose business is premised upon the weight-based dosing of children's OTC drug products. At the meeting, AccuDial Pharmaceutical supported and recommended the following to the panel:
- Dosing of acetaminophen for all children (12 lbs. to 95 lbs.) should be done primarily by WEIGHT (i.e., weight-based dosing) as it is the Standard of Care in Pediatrics and recommended by various industry Initiatives.
- Children should be dosed by Age only when their weight is not known.
- A single concentration (160mg/5mL) of acetaminophen should be marketed for use in all children. Concentrated Infants' Drops of Acetaminophen, which can include concentrations as much as 300% that of the standard 160 mg/mL dose, should not be manufactured any longer due to their contribution to the incidence of accidental acetaminophen overdoses by parents leading to death or serious injury in children.
- Acetaminophen pediatric liquid medications should include calibrated and clearly marked dosing spoons or oral syringes with doses consistent with the medication's label.
- The prominent display of a distinctive universal icon on the label of all OTC children's medications containing acetaminophen in order to reduce the risk of overdose due to a parent unknowingly giving a child multiple medications that include acetaminophen.
- The inclusion of "flow restrictors" in OTC liquid medication bottles containing acetaminophen in order to reduce the risk of overdose due to unsupervised ingestion by children.
- Better child-resistant packaging of acetaminophen products through newly designed closure systems and bottles that are child-proof to help reduce accidental ingestion.
- The maximum dose of acetaminophen should be increased from 480mg to 640mg to promote consistent weight-based dosing of acetaminophen at 15mg/kg, which has been accepted as a safe and effective dose of acetaminophen by the FDA (and supported by pediatric pharmacokinetic studies, i.e., Dr. Anthony Temple, 1983, Journal of Pediatric Pharmacology).
Dr. Brian Kaplan, M.D. gave AccuDial's recommendations to the committee and added, "I have treated over 15,000 children in my career as a physician and I believe these recommendations will resolve all the issues and problems relevant to dosing acetaminophen to children."
Wednesday morning the FDA Advisory Committee approved the following:
- Dosing instructions for children between ages 6 months to 2 years of age, based on weight and age; and
- Dosing instructions by weight (as well as age) on the Drug Facts label for all children's single-ingredient acetaminophen medicines.
ABOUT ACCUDIAL PHARMACEUTICAL
Children's AccuDial® is a revolutionary line of OTC medications designed to give your child an accurate dose of medicine. The weight of children in the same age group can vary greatly, and they should not always be given the same amount of medicine. According to the American Medical Association, 72% of children are dosed inaccurately with OTC medications. Using the patented AccuDial rotating dosing system, a caregiver simply turns the label of the bottle and matches the child's weight with the correct dose listed in milliliters.
The information contained in this press release include "forward looking statements." All statements other than statements of historical facts included in this press release, including the Company's prospects, plans, financial position and business strategy, may constitute forward-looking statements. These statements are based on the beliefs and assumptions of our management and on the information currently available to our management at the time of such statements. Forward looking statements generally can be identified by the words "believes," "expects," "anticipates," "intends," "plans," "estimates" or similar expressions that indicate future events and trends. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company can give no assurance that these expectations will prove to be correct, and the Company's actual results may differ significantly from the results discussed in these forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as the result of new information, future events or otherwise.
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SOURCE AccuDial Pharmaceutical, Inc.