MAY 5, 2011

In a move to curb overdoses of the pain and fever medicine acetaminophen, Johnson & Johnson and other drug makers will switch to a single concentration in their over-the-counter remedies for infants and children, according to three of the companies.

The medicines, including J&J’s Tylenol, now come in different concentrations depending on whether they are for infants or older children. That has made it confusing for parents to figure out how much to give, causing overdoses and, in rare cases, deaths.
In 2009, there were 14 hospitalizations caused by pediatric versions of medicines containing acetaminophen, but no deaths, according to the most recent data from the American Association of Poison Control Centers.

Under the move expected to be announced Thursday, drug makers will voluntarily discontinue the more concentrated infant drops and sell just a single concentration of infants’ and children’s medicines containing acetaminophen. The appropriate dose will still vary by age of the child.

Perrigo Co., which makes 95% of the kids’ acetaminophen medicines sold under private labels, says its products should be switched over to the single 160 milligrams per 5 milliliter concentration by the summer.
J&J’s McNeil Consumer Healthcare unit plans to roll out the single concentration as its infants’ Tylenol bottles return to the market later this year and the beginning of next, following a lengthy recall.
Novartis AG, maker of Triaminic, confirmed that the company would follow suit.
Acetaminophen is the most commonly used medicine for relieving pain and fevers in children, according to the Consumer Healthcare Products Association, which will be announcing the switch. According to a 2008 study, 23% of caregivers had given infants under 2 years of age a single-ingredient acetaminophen medicine during the previous week. Companies sold $153 million in kids’ acetaminophen medicines in the year leading up to April 10, Perrigo said.

Manufacturers of acetaminophen products have been under pressure from the U.S. Food and Drug Administration to help minimize medication errors. A 2009 meeting of experts convened by the agency prompted drug makers to revise the labels on medicine bottles and provide specific dosing instructions for children under 2.

Another meeting is scheduled for later this month to discuss further steps, such as adding to the labels to include dosing instructions based on children’s weight.

Switching to a single concentration will help prevent medication errors, “but I still think there could be better things done with the labeling,” said Allen Vaida, executive vice president of the Institute for Safe Medication Practices, who participated in the FDA’s 2009 meeting and serves on its Drug Safety and Risk Management Advisory Committee.

At the 2009 meeting, companies including J&J resisted moving to a single pediatric concentration. Now, J&J is seeking to regain the confidence of parents after more than a year of recalls of Tylenol and other popular brands. Last week, the company said it would give its medicine bottles a new cap, called a flow restrictor or dose-limiting cap, that allows parents to insert a syringe to draw out the correct dose.