A new, less-concentrated formula of infant acetaminophen has just hit the shelves, prompting the Food and Drug Administration to reinforce safety recommendations about the drug.
Until now, liquid acetaminophen for infants has been available in 80 mg/0.8 mL concentrations. The new product is a 160 mg/5 mL formula. Physicians should clearly specify which product to use, because confusion over the two formulas could lead to fatal overdoses, according to Carol Holtquist, director of FDA Division of Medical Error Prevention and Analysis.
"If a pediatrician prescribes a 5 mL dose of the less-concentrated liquid acetaminophen, but the parents administer a 5 mL dose of the more-concentrated liquid acetaminophen, the child can receive a potentially fatal overdose during the course of therapy," Ms. Holtquist said in a safety alert. "Conversely, if a physician prescribes a dose based on the more-concentrated liquid acetaminophen and the less-concentrated medication is used, the child might not receive enough medication to fight a fever."
The new formula may also be packaged with an oral syringe, instead of the dropper parents are accustomed to. It’s critical that adults giving the medication pay careful attention to the packaging directions, and use the correct device.
"Do not mix and match dosing devices," the FDA warned.
The new formulation is a response to the agency’s 2009 recommendation that manufacturers change their infants’ acetaminophen concentration to the lower 160 mg, to help prevent unintentional dosing errors that occurred with the 80-mg formula. The new product began appearing in stores earlier this year. "However, since this change is voluntary, products with the old concentration of acetaminophen marketed for infants are still available in stores and in medicine cabinets," the safety update noted.
Physicians should counsel parents carefully about giving acetaminophen to infants, the FDA said. Writing the desired dose and dosing directions on a prescription can help caregivers choose the recommended product and administer it correctly.
"[Physicians] should counsel caregivers on product differences," including how to read the label and instructions. "Caregivers should carefully read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen (in mg/mL), dosage, and directions for use."