FDA & Children’s Tylenol
May 14, 2011 by USA Post
FDA & Children’s Tylenol, Federal health officials are considering adding the dosing instructions for children under 2 years old for Children’s Tylenol and similar products, favored by many pharmaceutical and medical change.
The Food and Drug Administration meets next week to consider changes to the counter infant formulas that contain acetaminophen. Although safe when used as directed, acetaminophen has been the subject of the warning labels because of their potential to cause liver damage when overused.
The meeting will focus on a small group of liquid medications, including Tylenol, Triaminic, fevers children and babies’ little and several drugstore brands. These products have never contained information about the dosage for children under 2 to encourage parents to seek medical attention. Fever in infants under 6 months can be associated with dangerous infections such as meningitis and pneumonia.
The FDA said a group was asked whether the policy should be changed. Ananlysis by the agency showed that the majority of acetaminophen overdoses in children are found in children less than 2 years. FDA staff said the most common causes of the problems include: parent’s dosage misinterpretation of the information, giving a formula for a child or adult with a spoon or other delivery device rather than the cup included in the formula.
The FDA will also consider requiring dosing instructions based on weight with age-based instructions on the packaging, along with measuring cup universal formulas for all children. Almost all manufacturers have already adopted such measures voluntarily, but an FDA regulation that required them.
Dosing errors in children’s acetaminophen products accounted for 2.8 percent, or 7,500, of the 270,165 emergencies reported to poison control centers last year, according to the Dart Group.
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