At the intersection of bad marketing, inept regulation, and unwitting consumers, you’ll find the graves of young children, just some of the infants who, according to a new report from ProPublica, have become ill over the decades because Johnson & Johnson and other makers of acetaminophen-based painkillers insisted on selling two youth-targeted varieties of the drug while the FDA did what it does best — nothing.
Until 2001, Johnson & Johnson’s McNeil Consumer Products sold two types of Tylenol for parents and caregivers to use with children: Children’s Tylenol and Infant Tylenol. The two products contained different levels of acetaminophen and, surprising to some, the Infant formula actually had a higher concentration of acetaminophen than the Children’s version.
Making matters more confusing, FDA regulations meant that neither product contained specific dosing information for children under two years old, leaving that amount in the hands of the child’s physician. Which would have been fine, if there weren’t two similar products on the market that could be easily confused by doctors and patients alike.
See, if a child’s doctor or nurse assumes that the parent was using Children’s Tylenol, they would likely have suggested a larger dose than if the stronger Infant Tylenol was being used. But when the parents unwittingly bought, or were given, Infant Tylenol and used that higher dose, they put their child at risk for severe, possibly fatal, liver damage.
Between 2000 and 2009, the FDA received reports of 20 children dying from acetaminophen toxicity – a figure the agency said likely “significantly underestimates” the problem. Three deaths were tied directly to mix-ups involving the two pediatric medicines. Such errors may have caused some of the other deaths, but the agency has acknowledged that its data lacks sufficient detail to determine the precise cause….
[O]ne small study found that confusion between the two pediatric products was the most common reason for overdoses among kids with acetaminophen-related liver damage. A study conducted by McNeil found that about one child a year on average was hospitalized because of mix-ups involving its drugs.
Such tragic accidents are among the reasons that between 2001 and 2010, there were about twice as many deaths annually associated with acetaminophen than with all other over-the-counter pain relievers combined, according to data from the American Association of Poison Control Centers.
McNeil had asked the FDA for permission to put specific dosing instructions for infants on these products. Without this approval, it had to continue telling customers to get this guidance from their physicians.
Even after it became so clear that confusion over these dueling products were killing and injuring children that McNeil and others switched to a single-product system, the FDA has yet to allow clear dosing instructions for children two and under.
“It’s just not as straightforward as folks think,” a former FDA official explained — in 2002 — about why the agency had yet to approve infant dosing instructions for acetaminophen products, even though it had done so with ibuprofen-containing drugs. “But it is a priority to get done.”
Again, note that he said this in 2002. Eleven years ago.
Of course, instead of waiting for the FDA to do something about dosing instructions, McNeil could have ditched one of the two products. If there was only one product to choose from, then there can be no mix-up between doctors, nurses, parents, and retailers.
Testifying in a lawsuit brought by the parents of a child who died from acetaminophen toxicity, McNeil’s former medical director, Anthony Temple, admitted that he knew confusion between the two products had led to “maybe a couple of dozen, maybe a little more, where incidents of significant liver injury has occurred, and there’s probably a handful of those cases that were fatal.”
The plaintiffs’ attorney then asked, “And for 25 years you’ve elected to continue to offer Infants’ Tylenol in the concentrated form that has led to the death of babies, correct?”
To which, Temple replied, “Yes, we’ve continued to do it.”
Temple has said that the two versions of Tylenol remained on the market for years for the benefit of the children, and that switching to a single product for kids was “a second-best option” to getting those darn dosing instructions from the FDA.
“One death is too many,” PeterMax Miller, pharmaceutical marketing ethicist at the University of Colorado in Denver, and former exec at a competitor to J&J, tells ProPublica. “I would not have had any hesitation at all about yanking it off the shelf overnight. Everywhere. And Johnson & Johnson knows how to do that.”