• 22
  • June
    2011

Recently, the U.S. Food and Drug Administration's panel of health advisors voted to recommend placing additional dosing information on labels of medicines containing acetaminophen, a common fever reducer and pain reliever. Currently, labels of acetaminophen-containing drugs like Children's Tylenol provide dosing instructions for children over two years old.

For children under age two, the labels instruct parents to ask their doctor for an appropriate dose. The recommended dosing instructions are intended to protect young children from the risk of a drug overdose or medication error by supplying guidelines for dosing children between 6 months and two years old.

Protecting Children from Acetaminophen Overdosing

According to FDA data, acetaminophen-related overdoses are most common in children under two years old, and the number of these types of overdoses has increased over the past 10 years. The American Association of Poison Control Centers reported 270,000 overdoses of acetaminophen in 2010, and dosing errors accounted for 7,500 of those cases.

While acetaminophen is generally considered safe for young children, too much can cause liver toxicity, potentially leading to poisoning and liver failure, according to an Associated Press news report.

Dr. Richard Dart, president of the American Association of Poison Control Centers said that acetaminophen overdoses are rare but present potentially severe events that could lead to a child's death. The recommendation to change medicine labels "will lessen the chance that parents will give their children the wrong dose," he said, improving safety for our children.

Recommending Acetaminophen Dosing

The panel recommended that medicines containing acetaminophen provide dosing information based on children's weight. Considering the variation in children's weight in their early years, weight is a more accurate measure than age to determine an appropriate dose.

It is still best to verify dose amounts with doctors, but the FDA panel determined that providing dosing instructions for children age 6 months to two years is better than having parents guess the proper dose amount and unintentionally give too much to their children.

Source: FDA Advisers Urge Infant Doses for Kids' OTC Fever Relievers