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Tylenol Maker Tells Parents of Health Risks

New York Times, October 19, 1997

SAN FRANCISCO, Oct. 18 (AP)- The makers of Tylenol, the nation's most popular pain reliever, will tell parents for the first time through labels and advertising that too much of the drug can harm their children.

Relatively small overdoses of acetaminophen - Tylenol's active ingredient - have been blamed for liver damage and even deaths in children in the United States.

Containers with new labeling for infant Tylenol are scheduled to reach stores in six to seven weeks, said Ron Schmid, a spokesman for the manufacturer, McNeil Consumer Products Company.

Labels will caution that the contents are concentrated acetaminophen and that taking more than the recommended dose "could cause serious health risks," Mr. Schmid said on Friday.

Beginning next month, McNeil will also take out magazine advertisements to inform parents about correct dosages. A television campaign is un the works as well, Schmid said

Deborah Regosin-Hodges, whose 14-month old daughter, Sophie, underwent a partial liver transplant in 1994, applauded the labeling change. Sophie was accidentally overdosed because her parents and physician were unaware that grape-flavored infant Tylenol is 3 times stronger than children's Tylenol, according to a lawsuit they filed against the doctor and McNeil.

"I was very excited, and pretty surprised," Ms. Regosin-Hodges said of the labeling changes. "If nothing ever came out of this as far as our lawsuit goes, I would just be happy if another child was saved."

The Food and Drug Administration's over-the-counter drug advisory committee in September recommended additional changes in labeling for acetaminophen, which is also used in Anacin 3 and other pain relievers.

The F.D.A. wants manufacturers to explain correct dosages for children under 2 years old, instead of using the current language that simply directs parents to consult their doctors. McNeil, a subsidiary of Johnson & Johnson, supports the changes, Mr. Schmid said.

Critics say that children and infant's Tylenol comes in kid-pleasing flavors and is marketed as a safe alternative to aspirin and other pain relievers. Consumers were not told that giving a child as little as twice the proper dose over a period of time could destroy their livers.

Overdoses are all too easy, they say. Children like the taste and sneak an extra swig. Or Dad doesn't know Mom just gave the baby Tylenol and administers a second dose. Parents confuse regular, extra-strength, children's and infant's formulas.

The American Association of Poison Control Centers figures for 1996 show 31,511 children under 6 suffered inappropriate exposure to pediatric acetaminophen products. Most needed no treatment, but there were minor effects in 631 children, moderate - meaning requiring some treatment - in 63, and life-threatening or permanent effects in six.

John Bolton, a pediatrician from San Francisco, has campaigned for years to change Tylenol's marketing and said the tougher labels are a step in the right direction.

"The vast majority of people think that acetaminophen is a very inoccuous chemical and don't think twice about using it four or five times a day for a very minor fever," Bolton said.