two U.S. Food and Drug Administration advisory committees plan to meet Tuesday and Wednesday to decide whether to recommend that dosages of the instructions on the labels of medicinal products containing acetaminophen should be refined to protect children under the age of 2 against possible and even liver failure the death.
Currently, the labels of these drugs reducing fever, which include children Tylenol, have dosing instructions for children aged 2 years and more. For children less than 2 years, the labels simply tell parents "ask a doctor."
The American Academy of Pediatrics (AAP) and drug manufacturers are both strongly for giving parents the dosages of additional information.
"If give us parents better information, they can give enough medicine to work well, at the same time to minimize side effects," said Dr. Daniel Frattarelli, pediatrician at Dearborn, Michigan, who chairs the Committee for medicinal products of the Academy and who plans to testify before a jointmeeting for two days, the nonprescription drugs Advisory Committee and the Pediatric Advisory Committee.
"Parents want to do the right thing for their children," he said. "We as a medical community have give them this information so that they are able to do so.".
Although the evidence shows that acetaminophen is safe for young children, parents should be careful with it, pediatricians note. Giving too much can be toxic to the liver, causing the failure, poisoning and even liver.
In 2010, there were 270 000 overdose reported acetaminophen, according to the American Association of Poison Control Centers. Determination of the errors produced acetaminophen involving children represented about 7 500 cases - 3%.
In a perfect world, parents of babies and toddlers to consult even their pediatrician or pharmacist for determination of necessary drugs, said Dr. William Basco, Director of the General Pediatrics at the Medical University of South Carolina.
But the reality is that many parents are not to do this and is rather guess on the appropriate dosage. "There is no advantage to the parents to guess the correct dose", said Basco.
Makers of the drugs, including McNeil Consumer Healthcare, which makes Tylenol, also support the change.
"McNeil is committed to encourage the safe and proper operation of medicines in children, including the addition of new dosage information on acetaminophen Pediatric OTC label to help caregivers and health care providers to mix properly children."especially those 6 to 23 months old "society wrote in documents submitted to the FDA."
In comparison, medications containing ibuprofen - reducing of heavily used over-the-counter fever--already include dosing information for children aged of less than 2 years.
Medicines for children containing acetaminophen sold over-the-counter since 1959, and dosing information for children was on the labels since the 1970s, according to McNeil.
Back then, doses for children were somewhat crude - children 12 years and most were advised to take the dose for adults, children 6 to 12 were said to take half, and children aged less than 6 were told to take a quarter of the adult dose.
Since then, as doctors have learned more about drugs, dosage recommendations for infants and toddlers have become more refined and now should be based on weight, no age, according to AAP. (Age is always listed on the labelling of the packages, said AAP.) Weight of Kids' can vary widely at any age, the right dose for a child on the side most heavy is perhaps not the right dose for a smaller child of the same age.
Acetaminophen is safe, even in infants if used properly, drug manufacturers and the AAP call enlargement information labelling for children aged 6 months and more.
Parents should always be encouraged to consult their doctor before giving drugs to younger children, especially those aged less than 3 months, said Frattarelli. Fever greater than 100.4 degrees must be taken very seriously in infants, whose immune systems are not fully developed, and whose vaccination did not yet fully beaten, he explains.
The AAP will also recommend dosage instructions in millilitres, more accurate than teaspoons. "Many parents think that they can open the drawer for silverware and get a spoon, but this is not a good way to do so", said Frattarelli.
In addition, AAP intends to apply that acetaminophen will be sold in products marketed to children in formulations "single agent", rather than the products that contain acetaminophen and other drugs. That would help avoid the parents without wanting to give a double dose of acetaminophen because they gave their child say, a drug against cough also contains acetaminophen and Tylenol for children beyond this.
Earlier this month, the Consumer Healthcare Products Association, a trade association for manufacturers of prescription drugs, has agreed to sell that a concentration of acetaminophen in products for babies and children prevent errors of assays.
Previously, for example, the child Tylenol drops of liquid have been much more concentrated than Tylenol for children, which could easily lead to confusion if the parents did not read the label or whether there is a difference.
Drug manufacturers agreed to gradually eliminate the concentration drops infant from this year.
In a given week, approximately 23% of children aged under 2 years are acetaminophen, according to context of McNeil.
"Acetaminophen dosage errors are a rare adverse event but potentially very serious that can lead to failure liver or even death for the children,", said Dr. Richard Dart, President of the American Association of Poison control centres, in a press release. "This decision will reduce the chance that parents will give their children the wrong dose."
At the hearing, the FDA will also add a regimen based on the weight of the regimen based on age for children 2 to 12 and make it compulsory to include a universal measurement tool with the formulas for all children.
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