Acetaminophen in children: An old drug with new warnings

Question I frequently suggest to parents to use acetaminophen to treat their children’s fever and pain. Recently, I had a child in my office who presented with a target-lesion skin rash a day after receiving acetaminophen. The rash resolved after 3 days and after stopping administration of acetaminophen. Does acetaminophen carry a risk of adverse events such as this?Answer Like any other medication or active substance, acetaminophen preparations might carry a risk of adverse events. In recent years a potential association between acetaminophen and asthma was investigated, and the US Food and Drug Administration recently published a warning about potential severe but rare skin reactions associated with acetaminophen. Although acetaminophen is mostly a safe medication, health care providers should be alert and advise parents about the possibility of rare but severe adverse events.Acetaminophen is the over-the-counter (OTC) antipyretic¹ and analgesic² medication most commonly used in children. While a large number of parents underdose the medication for fever³ and are also unaware of the availability of the medication in a form for rectal administration (eg, for children who are vomiting),⁴ acetaminophen is being used commonly worldwide.^5–7Despite its frequent use and years of research, the exact mechanism of action of acetaminophen is unknown. Reduction of pain through suppression of inflammatory-related prostaglandins has been offered as a possible mechanism, and reduction of fever via a central effect on the temperature centre in the brain has also been shown. It is metabolized by the liver.Since the approval of acetaminophen by the US Food and Drug Administration (FDA) in 1951, a tremendous amount of research has been conducted on the drug, and thousands of reports have been published documenting its potential adverse effects.