Acetaminophen Continues to Rack Up Casualties and Escape Regulatory Control

Readers of the blog are familiar with the risks of acetaminophen, the active ingredient in Tylenol. Although this widely available, over-the-counter analgesic (pain medicine) is considered to be safe when taken at recommended doses, certain ordinary uses can damage or destroy the liver.

A described in a blockbuster investigative report by ProPublica.org, the FDA has long been aware of the science proving that acetaminophen can be risky, aware that the margin between the amount that helps and the amount that can harm is smaller than that of other over-the-counter pain relievers.

McNeil Consumer Healthcare, the unit of Johnson & Johnson that manufactures and promotes Tylenol, also understands the potential danger. The company has even promoted Tylenol’s safety in ads that say it’s the pain reliever “hospitals use most,” and the one “recommended by pediatricians.” See ProPublica’s companion piece on how confusion in pediatric dosing has killed some children due to inadvertent overdosing by their parents, and how the manufacturer and the FDA reacted to these unnecessary tragedies with glacial speed.

As ProPublica reports, McNeil has taken some steps to protect consumers, but for more than three decades, it has opposed safety warnings, dosage restrictions and other measures to ensure consumers fully understand the risks, and instead of proactively informing has worked to keep people from knowing the truth.

As the same time, federal regulators have diddled around, deferring decisions on consumer protections even while the FDA’s own advisory committees recommended them. The feds began a comprehensive review to set safety rules for acetaminophen in the 1970s. They haven’t finished yet. In the meantime, according to data from the Centers for Disease Control and Prevention (CDC), about 150 people die every year from acetaminophen overdose, which the agency even calls a “persistent, important public health problem.”

We’ve personally seen the unnecessary toll acetaminophen can take. One of the Tylenol lawsuits against McNeil referred to the in ProPublica story was ours. Our client, Antonio Benedi, had to have a liver transplant after taking standard doses of Tylenol for several days. He was a regular wine drinker who had no clue that alcohol significantly raised the risk of harm from acetaminophen, although McNeil knew. The jury decided the harm done to Benedi was worth more than $7.8 million in compensatory damages and $1 million in punitive damages.

That was almost 20 years ago. Still, as ProPublica shows, acetaminophen is injuring people who deserve regulatory and commercial protection they’re not getting. Benedi was quoted in last week’s ProPublica story: “[W]hen a company omits a known danger to them that could hurt people, they’re lying to us. I think that is outrageous.”

Every medicine, over-the-counter or prescription, has the potential to cause harm. Aspirin and ibuprofen, which often are options to acetaminophen, can lead to stomach bleeding, and in extremely rare cases, a potentially fatal skin reaction.

But acetaminophen carries a special risk. Approximately 1 in 4 Americans routinely take more over-the-counter pain relief pills of all kinds than they are supposed to, ProPublica reports. That’s especially ominous for acetaminophen, suggested one FDA report, because the drug’s narrow safety margin places “a large fraction of users close to a toxic dose in the ordinary course of use.”

So clear and so different are the risks of acetaminophen that at least 10 other industrialized countries restrict how much of the drug can be purchased at one time or require that pharmacies to be the only outlets that carry it.

In July, ProPublica notes, Johnson & Johnson’s over-the-counter revenue was up 26%. The company’s star product was Extra Strength Tylenol, which had doubled its market share the first half of this year. It was the No. 1 over-the-counter adult pain medicine in the U.S.

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