Tylenol Overdose Information
11/22/07 - Judge upholds $5 Million Judgement for 1-year-old who died after overdose of Infants' Tylenol
02/18/08 - Warning: Pain Relievers, Like Tylenol, Can Cause Death
03/22/08 - Acetaminophen Liver Damage on the Rise
09/01/08 - Anthrax Suspect Dies from Tylenol Overdose
12/21/06 - FDA proposes warning on acetaminophen painkillers 30 years after the fact
05/27/09 - FDA group recommends stronger warnings, dose limits for acetaminophen citing liver risk
J&J July 14, 2009 Conference Call: J&J “strongly” disagrees with an FDA advisory panel’s recent call for new limits on the sale of acetaminophen, the active ingredient in J&J’s Tylenol. The company has given its own recommendations to the FDA, which must make a final decision on what to do. “This will take some time to sort out,” Caruso said. He said that Tylenol for adults notches about $1 billion in yearly sales.
MARKETING TYLENOL: In the 1970s J&J sales reps began solemnly informing healthcare professionals that aspirin had been associated with Reye's syndrome. Johnson & Johnson used its army of sales reps to convinced doctors to routinely warn new moms about the risk for Reye’s syndrome in infants and toddlers who are given aspirin. It became common practice to give nursing mothers a small supply of Tylenol along with a warning to avoid aspirin when they checked out of hospital maternity wards.
That was phase one of J&J’s two-phase marketing strategy to persuade new moms to buy Tylenol.
Phase two involved setting up contracts with hospitals whereby J&J offered Tylenol at whatever price necessary to make sure Tylenol captured a monopolistic share of the non-prescription analgesic market at hospitals throughout the country. J&J gave Tylenol to hospitals for free if that’s what it took to dominate that piece of the market.
J&J executives knew that once they got patients started on Tylenol in the hospital, they would probably have a Tylenol customer for life. In the 1970s and 80s Tylenol represented 90 percent of the non-prescription analgesic market in hospitals.
It’s a tribute to Johnson & Johnson's marketing effort that so many people have heard of Reye’s and its association with aspirin, given how extremely rare it is. In 1986 there were approximately 100 cases in the U.S. In the UK there were 172 cases reported between 1986 and 1999; only 17 associated with aspirin use.
The data available does not confirm a specific or causal role for aspirin. It is likely that, if aspirin is involved in Reye's syndrome, it acts to compound injuries to an already stressed metabolism.
More Americans probably fear aspirin as a cause of Reye's syndrome than fear acetaminophen as a cause of severe liver damage. Yet there are approximately 2,000 cases of acute liver failure annually in this country, resulting in about 500 deaths. (see The Big Bucks in Tylenol)
Autism linked to Tylenol use?
The Long War on Aspirin
June 20, 2006
By FRED GARDNER
Johnson & Johnson’s Acetaminophen is the active ingredient in Tylenol. McNeil Laboratories first marketed it (in combination with a barbiturate) in 1953 as a safer alternative to aspirin. The big selling point was that aspirin, then the best-selling painkiller, is hard on the stomach. Preceding the launch, McNeil had hired a leading critic of aspirin, a gastroenterologist named James Roth, and organized a conference. "In 1951," the company history recounts, "the safety and efficacy of acetaminophen was described at a scientific symposium in New York City sponsored by the Institute for the Study of Analgesic and Sedative Drugs.
According to the research reported at this symposium, acetaminophen was found to be as effective as aspirin for pain relief and fever reduction, but without the side effects of aspirin such as stomach irritation, gastrointestinal bleeding, and impairment of the blood to clot normally.
"McNeil launched Tylenol Elixir for Children -pure acetaminophen- in 1955. The company history says, "The outstanding success of Tylenol was attributed to a unique marketing strategy: to inform health care professionals of the undesirable effects of aspirin and ask them to recommend Tylenol to patients susceptible to these effects."
After Johnson & Johnson acquired McNeil in 1959 the safer-than-aspirin pitch was complemented by a massive giveaway of the product to doctors and hospitals, creating market share by irresistible financial force.
In the 1970s J&J sales reps began solemnly informing healthcare professionals that aspirin had been associated with "Reye's syndrome" (pronounced "Rise") a potentially fatal condition involving the liver and ultimately the brain of infants and children following viral illness. In 1982 the Surgeon General issued a warning to this effect. (Ralph Nader's Public Health Research Group received credit in the media for pressuring the government to act.) In 1986 the FDA required all aspirin products in the U.S. to carry a warning label stating "children and teenagers who have or are recovering from chicken pox, flu symptoms or flu should NOT use this product."
A second sentence was added in 2003: "If nausea, vomiting, or fever occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a rare but serious illness."
It is a tribute to Johnson & Johnson's marketing effort that so many people have heard of Reye's and its association with aspirin, given how extremely rare it is. In '86 there were approximately 100 cases in the U.S. In the UK there were 172 cases reported between 1986 and 1999 -only 17 associated with aspirin use.
Aspirin (an extract of willow bark) is not as benign as cannabis, but it, too, has been on the receiving end of a corporate disinformation campaign. J&J has whipped up exaggerated fears of lethality.
In 2004 an Australian government committee evaluated the Reye's warning statement on aspirin in a report that noted numerous inconsistencies in the diagnosis itself. "The viral illness which proceeds Reye's Syndrome varies" from country to country, the report said. In the US almost all Reye's cases involve varicella or influenza A or B; but in the UK and Australia, gastrointestinal and other viruses are involved. "In the US, the cases are usually over five years of age, with a median age of six-seven years. In the UK the median age of cases was 10-15 months ... These differences between Reye's Syndrome as it is commonly seen in the US and the UK and Australian cases, have led to questions about whether the term 'Reye's Syndrome'refers to the same disease in both countries or, in fact, whether it refers to a single disease at all, or a heterogeneous group of disorders ...
"Despite over 20 years of study, there is still debate about the nature of the association between aspirin and Reye's Syndrome," according to the Australian report, whose authors reviewed all the relevant studies. In many cases it turned out that the symptoms attributed to Reye's were actually manifestations of inborn errors of metabolism -the body couldn't make enough of a certain enzyme. In 1987 a researcher named Orlowski at the Children Hospital in Camperdown -Reye's old hospital- reviewed the records of 20 patients diagnosed with Reyes and found that only one had been administered aspirin, and "this patient had a zero salicylate level when admitted hospital after severe vomiting."
In 1999 Orlowski reevaluated 26 surviving Reye's Syndrome patients who had been assessed in 1990 and found that 18 had been diagnosed in the intervening years with other conditions, 15 of them with inborn metabolic disorders. Orlowski also reanalyzed the records of all 49 patients in the 1990 study and determined that "six had probable Reye's Syndrome, two had possible Reye's syndrome, 23 were unlikely to have had Reye's Syndrome, and Reye's Syndrome was excluded in 18 patients."
The report notes that "A number of studies have been conducted to investigate how aspirin could be involved in Reye's Syndrome. However, no clear mechanism of action has been defined. It is clear from the epidemiology studies that other factors apart from viral illness and aspirin exposure are involved ... The data available does not confirm a specific or causal role for aspirin. It is likely that, if aspirin is involved in Reye's syndrome, it acts to compound injuries to an already stressed metabolism."
More Americans probably fear aspirin as a cause of Reye's syndrome than fear acetaminophen as a cause of severe liver damage. Yet, as discussed in a previous column there are approximately 2,000 cases of acute liver failure annually in this country, resulting in about 500 deaths.
Acetaminophen overdose is the leading cause for calls to Poison Control Centers (133,000 in '04, more than half required a trip to the ER or doctor's office). The mechanism of action is not mysterious: the liver, as it breaks down acetaminophen, makes a toxic compound, N-acetyl-para-benzoquinoneimine, which is then transformed to a benign one. In cases of overdose, the liver can't fully process the toxin, which accumulates. For those with liver damage from hepatitis and/or heavy alcohol use, a "therapeutic" dose can lead to acute failure. Recently Dr. William Lee presented data at a conference showing that one in eight cases of acute liver failure attributed to hepatitis B also involves acetaminophen poisoning.
Your correspondent asked Dr. Lee why manufacturers combine -"bundle"- acetaminophen with synthetic opiates, as in Percocet and Vicodin. (Tylenol with codeine is ubiquitous, while most U.S. pharmacies don't even stock aspirin with codeine.)
Lee replied, "The point of the bundling from the physician's standpoint is that you do not need a triplicate form to fill in which most of us use very rarely -have, but keep in a bottom drawer and (like me yesterday) cannot find... when we are on the run and trying to get someone relief. These compounds are the only ones that can be called in and written on a plain scrip. Not sure how it got enacted, however."
If the rationale for making the acetaminophen-opioid drugs available by "plain scrip" is regulatory rather than medical, we suspect that J&J lobbyists had a hand in establishing it. This is not a conspiracy theory, it's a conspiracy hypothesis. There are people in DC who should be able to substantiate or disprove it. The question is: which lobbyists working for which corporations fixed which codes so that "bundling" drugs would facilitate prescription writing?
Johnson & Johnson has paid out countless millions of dollars over the years to settle suits by Tylenol victims and minimize adverse publicity. Occasionally the wall of silence by the corporate media gets breached, but the message that Tylenol causes liver damage has yet to reach the masses. A 1998 article in Forbes by Thomas Easton and Stephen Herrera critiqued J&J's strategy:
"J&J has made grudging concessions, strengthening the warning label a little at a time... Why not warn about people about possible liver failure? J&J says that 'organ specific' warnings would confuse people. Why not talk about the risk of death? That would promote suicides, says the company." The Forbes piece concluded, "[CEO James] Burke's successor has a painful choice. He can rewrite the label, putting on it the verbal equivalent of a skull and crossbones. Or he can go on paying off victims, and hope for the best."
Congressional Report: FDA Unable to Protect Public from J&J Drugs
Case Study: The Johnson & Johnson Tylenol Crisis
Department of Defense (DoD) Joint Course in Communication, Class 02-C, Team 1
Before the crisis, Tylenol was the most successful over-the-counter product in the United States with over one hundred million users. Tylenol was responsible for 19 percent of Johnson & Johnson's corporate profits during the first 3 quarters of 1982. Tylenol accounted for 13 percent of Johnson & Johnson's year-to-year sales growth and 33 percent of the company's year-to-year profit growth. Tylenol was the absolute leader in the painkiller field accounting for a 37 percent market share, outselling the next four leading painkillers combined, including Anacin, Bayer, Bufferin, and Excedrin. Had Tylenol been a corporate entity unto itself, profits would have placed it in the top half of the Fortune 500 (Berge, 1998).
During the fall of 1982, for reasons not known, a malevolent person or persons, presumably unknown, replaced Tylenol Extra-Strength capsules with cyanide-laced capsules, resealed the packages, and deposited them on the shelves of at least a half-dozen or so pharmacies, and food stores in the Chicago area. The poison capsules were purchased, and seven unsuspecting people died a horrible death. Johnson & Johnson, parent company of McNeil Consumer Products Company which makes Tylenol, suddenly, and with no warning, had to explain to the world why its trusted product was suddenly killing people (Berge, 1998).
Primary Evidence. Robert Andrews, assistant director for public relations at Johnson & Johnson recalls how the company reacted in the first days of the crisis: "We got a call from a Chicago news reporter. He told us that the medical examiner there had just given a press conference-people were dying from poisoned Tylenol. He wanted our comment. As it was the first knowledge we had here in this department, we told him we knew nothing about it. In that first call we learned more from the reporter than he did from us." Andrew's dilemma points out something that has become more prevalent with the expansion of 24 hour electronic media. The media will often be the first on the scene, thus have information about the crisis before the organization does (Berge, 1990).
Johnson & Johnson chairman, James Burke, reacted to the negative media coverage by forming a seven-member strategy team. The team's strategy guidance from Burke was first, "How do we protect the people?" and second "How do we save this product?" The company's first actions were to immediately alert consumers across the nation, via the media, not to consume any type of Tylenol product. They told consumers not to resume using the product until the extent of the tampering could be determined. Johnson & Johnson, along with stopping the production and advertising of Tylenol, withdraw all Tylenol capsules from the store shelves in Chicago and the surrounding area. After finding 2 more contaminated bottles Tylenol realized the vulnerability of the product and ordered a national withdraw of every capsule (Broom, 1994).
By withdrawing all Tylenol, even though there was little chance of discovering more cyanide laced tablets; Johnson & Johnson showed that they were not willing to take a risk with the public's safety, even if it cost the company millions of dollars. The end result was the public viewing Tylenol as the unfortunate victim of a malicious crime (Broom, 1994).
Johnson & Johnson also used the media, both PR and paid advertising to communicate their strategy during the crisis. Johnson & Johnson used the media to issue a national alert to tell the public not to use the Tylenol product. In the first week of the crisis Johnson & Johnson established a 1-800 hot line for consumers to call. The company used the 1-800 number to respond to inquires from customers concerning safety of Tylenol. They also establish a toll-free line for news organizations to call and receive pre-taped daily messages with updated statements about the crisis (Berge, 1990).
Before the crisis Johnson & Johnson had not actively sought press coverage, but as a company in crisis they recognized the benefits of open communications in clearly disseminating warnings to the public as well as the company's stand (Broom, 1994).
Several major press conferences were held at corporate headquarters. Within hours an internal video staff set up a live television feed via satellite to the New York metro area. This allowed all press conferences to go national. Jim Burke got more positive media exposure by going on 60 Minutes and the Donahue show and giving the public his command messages (Fink, 1986).
Johnson & Johnson communicated their new triple safety seal packaging- a glued box, a plastic sear over the neck of the bottle, and a foil seal over the mouth of the bottle, with a press conference at the manufacturer's headquarters. Tylenol became the first product in the industry to use the new tamper resistant packaging just 6 months after the crisis occurred (Berge, 1990).
Secondary Evidence. The initial media reports focused on the deaths of American citizens from a trusted consumer product. In the beginning the product tampering was not known, thus the media made a very negative association with the brand name.
All 3 networks lead with the Tylenol story on the first day of the crisis. CBS put a human face on the story which contained the following: "When 12 year-old Mary Kellerman of Elk Grove Village, Ill., awoke at dawn with cold symptoms; her parents gave her one Extra-Strength Tylenol and sent her back to bed. Little did they know, they would wake up at 7:00 a.m. to find their daughter dying on the bathroom floor." (Kaplin, pg. 1, 1998)
The print media weighed in with equally damaging headlines: Time Magazine, "Poison Madness in the Midwest," Newsweek, "The Tylenol Scare," The Washington Post, "Tylenol, Killer or Cure."
The media was not only focused on the deaths but it was also pervasive. Throughout the crisis over 100,000 separate news stories ran in U.S. newspapers, and hundreds of hours of national and local television coverage. A post crisis study by Johnson & Johnson said that over 90 percent of the American population had heard of the Chicago deaths due to cyanide-laced Tylenol within the first week of the crisis. Two news clipping services found over 125,000 news clippings on the Tylenol story. One of the services claimed that this story had been given the widest US news coverage since the assassination of President John F. Kennedy (Kaplin, 1998).
Media reporting would continue to focus on Tylenol killing people until more information about what caused the deaths was made available. In most crises media will focus on the sensational aspects of the crisis, and then follow with the cause as they learn more about what happened.
Scholarly Journals. Scholars have come to recognize Johnson & Johnson's handling of the Tylenol crisis as the example for success when confronted with a threat to an organization's existence. Berge lauds the case in the following manner, "The Tylenol crisis is without a doubt the most exemplary case ever known in the history of crisis communications. Any business executive, who has ever stumbled into a public relations ambush, ought to appreciate the way Johnson & Johnson responded to the Tylenol poisonings. They have effectively demonstrated how major business has to handle a disaster." (pg. 19, 1990)
The Tylenol case was the bases for many of the crisis communications strategies developed by researchers over the last 20 years. Berg's suffering strategy and Benoit's Rectification strategies both were developed from doing case studies of how Johnson & Johnson handled the Tylenol poisonings (Coombs, 1995).
Discussion. The crises category in the Johnson & Johnson Tylenol case is Terrorism. Combs defines terrorism as intentional actions taken by external actors designed to harm the organization directly (hurt employees or customers) or indirectly (reduce sales or disrupt production). Product tampering, hostage taking, sabotage, and workplace violence are examples of terrorism. The violent, outside agent promotes attributions of external locus and uncontrollability.
The Tylenol product tampering clearly fits the Terrorism category. An external agent, presumably, acted to hurt the customers and possibly the employees of Johnson & Johnson. The other categories, Faux Pas, Accidents, or Transgression do not fit in the Tylenol case, so there was no cross-categorization in this case.
Crisis Response Strategies used by Johnson & Johnson: Johnson & Johnson employed Forgiveness and Sympathy strategy for this crisis. Forgiveness strategy seeks to win forgiveness from the various publics and create acceptance for the crisis.
Johnson & Johnson used Remediation and Rectification, both Forgiveness strategies, in the Tylenol crisis. Remediation offers some form of compensation to help victims of the crisis. Johnson & Johnson provided the victim's families counseling and financial assistance even though they were not responsible for the product tampering. Negative feelings by the public against Johnson & Johnson were lessoned as the media showed them take positive actions to help the victim's families (Berg, 1990).
Rectification involves taking action to prevent a recurrence of the crisis in the future. Johnson & Johnson's development of Triple sealed packaging is an example of rectification. They also developed new random inspection procedures before the shipment of Tylenol to retailers (Berg, 1990).
Sympathy strategy was a big component of Johnson & Johnson's crisis communication strategy. Sympathy strategy wins support from the public by portraying the organization as the unfair victim of an attack from an outside entity. Johnson & Johnson's willingness to accept losses by pulling the Tylenol product developed sympathy with the public (Berg & Robb, 1992).
The Johnson & Johnson Tylenol crisis is an example of how an organization should communicate with the various publics during a crisis. The organization's leadership set the example from the beginning by making public safety the organizations number one concern. This is particularity important given the fact that Johnson & Johnson's main mission with Tylenol is to enhance the public's well-being or heath.
Although Johnson & Johnson's leadership performed superbly during the crisis there were some important areas Tylenol improved upon after the crisis. Johnson & Johnson did not have a proactive public affairs program before the crisis. The only media relations engaged in by Johnson & Johnson was in the advertising and marketing area. In the early stages of the crisis Tylenol was informed about what was going on from a Chicago reporter. If this particular reporter had been more contentious or adversarial the whole crisis may have taken on a different form in the public's perception.
Johnson & Johnson's failure to employ/establish a positive relationship with the media, a key stakeholder, forced the company to respond to the crisis in an advertising-like manner. Johnson & Johnson received criticism from the media for not being genuine due to the slick sales-like response ads run during the crisis. The personal messages with the media from the CEO of the organization enabled Johnson & Johnson to overcome this problem.
Today Johnson & Johnson has completely recovered its market share lost during the crisis. The organization was able to reestablish the Tylenol brand name as one to the must trusted over-the-counter consumer products in American. Johnson & Johnson's handing of the Tylenol crisis is clearly the example other companies should follow if the find themselves on the brink of losing everything.
NYT: March 5, 1986
PAINKILLER IN TYLENOL IS LINKED TO LIVER DAMAGE IN ALCOHOLICS
By ERIK ECKHOLM
Medical scientists warned yesterday that acetaminophen, the painkiller in Tylenol and many other aspirin substitutes, can cause serious liver damage in alcoholics. Two experts recommended that chronic, heavy drinkers not use the drug and called on the Federal Government to require that warnings of the danger be included on product labels.
''This is an underappreciated problem,'' said Dr. Edward J. Huth, editor of The Annals of Internal Medicine, which is publishing a new report on the problem today.
A medical spokesman for Johnson & Johnson, the manufacturer of Tylenol, which has been the nation's most popular acetaminophen product, responded that such cases of liver damage were rare and confined to severe alcoholics who had exceeded the recommended dosage. The spokesman said company officials had not yet had a chance to review the new study and were concerned that it would create unwarranted alarm because it was appearing in a climate of public fear about the safety of Tylenol products.
Johnson & Johnson halted sales of Tylenol in capsule form last month after cyanide-tainted capsules of Extra-Strength Tylenol were discovered on store shelves, a matter unrelated to today's report. #5 Deaths Are Cited The new study, by Dr. Leonard B. Seeff of the Veterans Administration Medical Center in Washington and four colleagues, described 25 patients, all chronic alcoholics, who developed liver disorders after taking acetaminophen at doses the scientists described as ''in or near the therapeutic range.'' Five of the patients died.
The scientists said it was impossible to estimate the overall prevalence of the toxicity problem or its fatality rate. But they said such poisonings might be more widespread than published reports indicated. They and another expert said they suspected that doctors had failed to detect many cases of acetaminophen poisoning in alcoholics, confusing it with liver ailments caused by alcohol abuse itself.
The study's principal author and a second expert said alcoholics, many of whom had been told by doctors that acetaminophen was safer for them than aspirin, should be cautioned against the drug.
''It's a potential threat,'' said Dr. Seeff. ''If someone in my family were an alcoholic, I'd strongly advise them not to take Tylenol.''
''Chronic heavy drinkers should avoid acetaminophen altogether,'' said Dr. Martin Black, an expert on liver disorders at the Temple University School of Medicine. ''Or if they use it, they should only take regular-strength tablets, and not exceed six tablets a day.''
Dr. Thomas N. Gates, medical director of the McNeil Consumer Products Company, the Johnson & Johnson subsidiary that makes Tylenol, said alcoholics need not avoid the drug but that they should be warned not to exceed the recommended dose.
Standard ''regular-strength'' tablets contain 325 milligrams of acetaminophen, while ''extra-strength'' tablets contain 500 milligrams. Severe liver damage has been documented in some patients taking as little as 3,000 milligrams, or 3 grams, a day, according to Dr. Black, and in other reported cases patients have taken amounts from 3 to 17 grams. The recommended maximum daily dose is 4 grams.
The Federal Government estimates that nearly 11 million American adults are alcoholics. Dr. Seeff said he could not specify what levels of alcohol consumption over what period would expose a person to acetaminophen toxicity. But he stressed that only persistent, heavy drinkers appeared to be at risk. There is no evidence, he said, of danger to those seeking relief from headaches after isolated episodes of hard drinking.
The effects of acetaminophen poisoning cannot be distinguished from those of alcohol-caused liver disease without analysis of the patient's blood, which reveals marked differences in enzyme patterns between the two conditions, experts said. Patients usually suffer few symptoms until the damage is severe, manifested in jaundice and nonspecific complaints such as nausea, vomiting and abdominal pain.
In today's report, the scientists worried that unsuspecting physicians might administer acetaminophen to a liver-damaged patient who is already suffering a toxic effect from the drug. ''A fatal outcome might then be attributed to the underlying alcoholic liver disease,'' the report said.
In interviews yesterday, both Dr. Seeff and Dr. Black said they believed the Food and Drug Administration should require products containing acetaminophen to bear a warning about the possible hazards for chronic, heavy drinkers. Dr. Gates said his company had been studying whether to add a notice about the problem to its labels.
A spokesman for the F.D.A. said the need for new labeling requirements would be studied in light of new evidence, but that past reviews had indicated the problem was not common enough to warrant a special warning.
For people who are prone to stomach bleeding, a condition common among alcoholics, doctors often recommend acetaminophen as an alternative to aspirin and ibuprofen, the other two leading painkillers available without prescription, because it is less likely to irritate the stomach.
But in view of the possible threat to the liver, scientists said, for some alcoholics acetaminophen might be as dangerous as aspirin or more so.
''I'm saying that for the chronic drinker, neither drug is ideal,'' Dr. Seeff said. ''Chronic drinkers face a problem.''