Thursday, May 19th, 2011
The FDA’s Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee met yesterday morning to discuss adding dosing directions for infants to the labels of medication containing acetaminophen.
Currently, labels instruct parents to consult pediatricians first before dosing kids under 2 years old. The advisory committees voted in three rounds (two were unanimous) to have future labels include dosing instructions for children as young as 6 months. The dosing instructions were to be based on weight, not age, for accuracy.
As over-the-counter drug manufacturers move toward a standard acetaminophen concentration for liquid medicine, based on a mandate by the FDA, the advisory committees also voted that pills, chewables, and meltaway tablets should also have one standard acetaminophen concentration in the future.
Incorrect dosing of acetaminophen, which is commonly used to relieve symptoms of pain and fever in young children, can lead to liver poisoning. If the FDA agrees to what the committees advise, infant medicine containing acetaminophen will have clearer instructions in the future.
Read more of the lateste acetaminophen news:
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Monday, May 9th, 2011
In light of last week’s acetaminophen news, Parents spoke to Dr. Edward Kuffner, M.D., Vice President, OTC Medical Affairs & Clinical Research for McNeil Consumer Healthcare, the makers of Tylenol. Tylenol, part of Johnson & Johnson, is already in the process of making changes to their infants’ and children’s products, says Kuffner.
Along with other OTC medicine manufacturers, Tylenol will be standardizing the acetaminophen doses for infants and children. Currently, Tylenol has removed their infants’ medication from store shelves so only children’s medication is available, but they will still remain separate products. This means infants’ medication will be back in stores in time for the upcoming cold and flu season.
Formulas are also remaining the same, but bottles and dosing equipment will be updated. Infants’ and Children’s liquid Tylenol will have enhanced bottles with flow restrictors that will prevent spilling, provide ease of dispensing, and stop kids from drinking out of the bottle easily. Infants’ Tylenol will also have a new dosing device, a clearly-marked syringe that will provide accurate dosing and administration. Children’s Tylenol will still include a clearly-marked cup.
Right now, all OTC (not just Tylenol) infants’ and children’s medication do not include proper dosing information for children under 2. Instead, labels instruct parents to consult pediatricians. Tylenol is also working with the FDA to change this to include proper dosing instructions for children 6 months and up. Parents with children under 6 months should still consult pediatricians.
Tylenol also has these helpful tips, formed from the acronym NURSE, for giving medicines to infants and children:
Never give adult medicines to children.
Use the measuring device (syringe, dropper, dosage cup) that comes with the medicine every time you use it. Don’t use kitchen spoons (teaspoons or tablespoons).
Read and follow instructions on the label. Never give more than the recommended dose and do not give the medication more frequently than recommended.
Store all medicines out of the reach of children. Immediately following use, always restore the child resistant cap and put the medicine back into a high and out of sight location.
Every child grows. Know the infant’s or child’s weight and/or age to help determine the appropriate dosage.
Dr. Kuffner says it’s always best to dose according to your child’s weight instead of age, since it’s more accurate. If you don’t know your child’s weight, dose by age or consult a doctor.
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Thursday, May 5th, 2011
Starting as early as June, over-the-counter drug manufacturers will no longer produce acetaminophen in concentrated liquid drops for infants. Acetaminophen, a common ingredient in various OTC medications for children, is included to reduce symptoms of pain and fever.
The Consumer Healthcare Products Association (CHPA), a non-for-profit group that represents OTC drug manufacturers, decided on this step to reduce dosing errors and prevent accidental poisonings in infants. Currently, liquid acetaminophen is sold in two concentrations: 80 mg/0.8 mL or 80 mg/1.0 mL, with droppers for infants; 160 mg/5 mL, with cups for children ages 2-11. The two different concentrations have often caused confusion, leading parents to give kids incorrect doses due to badly-marked droppers or cups.
Johnson & Johnson and other drug manufacturers will cease production of the 80 mg/0.8 mL and the 80 mg/1.0 mL concentrations through 2012. Instead, 160 mg/5 mL will become the standard concentration for all ages, along with cups for older kids and new syringes with flow restrictors for infants, which will provide accurate dosing and reduce spills. Most medications with acetaminophen do not have proper dosing instructions for kids under 2 years; instead, the labels instruct parents to contact pediatricians. Tylenol, produced by Johnson & Johnson, will be working on a case to urge the Food and Drug Administration (FDA) to include correct acetaminophen dosing information for children 6 months and up on labels.
For now, both concentrations will still be on shelves until CHPA can work with retailers to remove the infant concentrations. Parents can keep acetominophen medications they already have or purchase them in stores, but read labels and dosing directions carefully. Always consult a trusted pediatrician to clarify the concentration of your child’s dose, especially if you have any questions or concerns.
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