On April 24, 1995, Marcus Trunk, a 23-year-old construction worker from Upper Dublin, Pa., died from treating a sprained wrist with Tylenol, a drug he thought was completely safe
This April, the first of two dozen pending cases involving plaintiffs who fell seriously ill or died from the same medication will be heard in a New Jersey court. And 120 more cases are headed for federal court in Philadelphia. They claim that McNeil-PPC Inc., the company that makes Tylenol, and others repeatedly concealed the serious health risks of the painkiller, also known as acetaminophen.
Tylenol is the best-known brand name for acetaminophen, but the drug is an ingredient in more than 600 products such as Sudafed, Robitussin, NyQuil, Cepacol and Coricidin. It is so ubiquitous that consumers can — and regularly do — unwittingly take much more than they should. It's those multiple doses that can be lethal.
For decades, experts urged the Food and Drug Administration to take a few simple steps to protect the public from acetaminophen poisoning. And for decades, they watched in frustration as other countries took those steps, while little progress was made here.
Acetaminophen is the No. 1 cause of acute liver failure in the United States. Overdoses send more than 78,000 people to the emergency room a year. Studies suggest that several hundred people die from accidental acetaminophen toxicity each year, like Marcus Trunk.
"In some ways, it's not a huge number," said William Lee, a liver disease expert at the University of Texas Southwestern Medical Center in Dallas. "But most of them are young, healthy people. These are preventable deaths."
The pain reliever is effective when taken correctly. But it has a narrow margin of safety and can quickly become toxic when taken in doses not much greater than the recommended limits, or when combined with alcohol. And because acetaminophen is in so many drugs, people often have no idea how much they have taken. (The FDA has ruled only recently that narcotic combination painkillers such as Percocet and Vicodin no longer list the cryptic abbreviation "APAP," and instead spell out "acetaminophen" on the label.) Even hospitals lose track, giving patients more than the maximum.
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While the FDA has gradually required stronger health warnings on labels, critics say that the agency has acted too slowly and meekly.
For 19 years, one of the most compelling voices among them has been Kate Trunk's.
After graduating from high school, Marcus, the older of her two sons, went to work for his uncles, restoring brick buildings in Philadelphia.
When he hurt himself on the job, his doctor prescribed Tylenol 3, a painkiller containing codeine and 300 milligrams of acetaminophen in each pill. Still in pain, but eager to get back to work, Trunk also took some regular Tylenol, which had been marketed for decades as the analgesic that "hospitals recommend most." Each of those pills contained 325 milligrams of acetaminophen.
Soon, he grew achy and feverish. Thinking he had a cold, he treated himself with Thera-flu, which also contains acetaminophen — 650 milligrams in each dose.
His symptoms grew worse, Kate Trunk said, until he ended up in Abington Memorial Hospital, where the doctors suspected he had hepatitis. "They gave him more Tylenol," she said.
His parents had just moved to Florida. On Easter Sunday, they got a call from the hospital. Kate flew to Philadelphia immediately.
As she stood by his bedside, she remembers him telling her, "Oh, Ma, I think I'm going to die."
A week later, Marcus was dead. "When the autopsy report came back, we said, 'acetaminophen toxicity? What's that?' Is it incredibly rare? It turned out it wasn't incredibly rare."
That summer, Kate and Carmen Trunk began fighting for more explicit warnings on the labels of all medications containing acetaminophen, warnings that they believe might have saved their son's life. "I would have loved for it to happen bam, bam, bam," she said. "But that's not how it works."
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Since the late 1960s, evidence had been mounting that the drug can be lethal in doses exceeding 4,000 milligrams a day, and less when combined with alcohol. Anyone who has been fasting or eating very little, as those who are ill tend to do, is also at greater risk for liver damage from the drug.
In 1977, an advisory committee appointed by the FDA asked the agency to set a "standard dose" of no more than 325 milligrams of acetaminophen in any one pill. The group also said a warning about liver damage should be "obligatory" on labels. But it was not until 2001, when another FDA panel reached the same conclusions, that the agency began to take action.
It is important to note, health experts warn, that the primary over-the-counter alternatives to acetaminophen — aspirin and other non-steroidal anti-inflammatories — have their own dangerous side effects. They can cause ulcers and gastric bleeding. (Unlike non-steroidal anti-inflammatories and aspirin, Tylenol does not reduce inflammation. Rather, it reduces fever and mitigates pain.) And in children, aspirin can cause Reye's syndrome, a potentially fatal condition.
Acetaminophen dosing for children is even more confusing than for adults. Currently, labels do not offer any recommended dose for children under 2 years old. Instead, parents and caretakers are told to ask a doctor.
Three years ago, the FDA asked manufacturers of prescription drugs with acetaminophen to voluntarily limit the amount to 325 milligrams in each pill by Jan. 14, 2014. As of the deadline, about half the manufacturers had complied, the FDA reported.
"We hepatologists have been asking for a long time that the FDA follow the lead of the United Kingdom, which limited amounts years ago," said Santiago Munoz, director of the Center for Liver Disease at Capital Health Medical Center in Pennington, N.J. The United Kingdom also requires drugs with acetaminophen to be packaged in blister packs, forcing the consumer to be more deliberate.
The 325-milligram limit for prescription tablets "is a first step," Munoz said.