Posted On: September 27, 2013 by Patrick A. Malone

How Big Pharma and the Feds Caused Infant Deaths Over Confusing Acetaminophen Dosages

For 15 years, McNeil Consumer Healthcare, a division of Johnson & Johnson, had sold two versions of Tylenol for young children even though the company knew that parents and doctors were confusing the two. They knew that confusion could have serious, even deadly, results. The FDA ignored the problem.

We’ve addressed the problem with dosing with acetaminophen, the active ingredient in Tylenol, and now a shocking story by the investigative news site probes even deeper into the confusion over the two types of pediatric Tylenol, and why that’s so dangerous. Remarkably, the story says, “Drop for drop, the strength of Infants’ Tylenol far exceeded that of Children’s Tylenol.

“In addition, the active ingredient in Tylenol, acetaminophen, has what the FDA deems a narrow margin of safety. The drug is generally safe at recommended doses, but the difference between the dose that helps and the dose that can cause serious harm is one of the smallest for any over-the-counter drug.”

Other manufacturers’ products compounded the problem by also offering two children’s products with different concentrations of acetaminophen. Between 2000 and 2009, 20 reports of children who died from acetaminophen toxicity were filed with the FDA, which acknowledged that the figure probably “significantly underestimates” the true incidence.

Between 2001 and 2010, according to the American Association of Poison Control Centers, about twice as many deaths each year were associated with acetaminophen than with all other over-the-counter pain relievers combined, according to data from. Tens of thousands more are hospitalized for overdoses.

ProPublica tells the heartbreaking stories of babies who suffered unnecessarily. To see how the intersection of federal regulatory sloth and pharmaceutical company misbehavior conspired to harm and sometimes kill people seeking only to relieve pain, see our blog, “Acetaminophen Continues to Rack Up Casualties and Escape Regulatory Control.”

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