The amount of acetaminophen these patients had ingested was close to the recommended daily dose of 4 grams. The median was 6 grams per day — a surprise, because the toxic dose was thought to be between 10 and 15 grams, Erush said. She also found that most of these patients had other risk factors, such as chronic alcohol use. McNeil said that it had asked Lee and Erush for patient information in order to examine their conclusions. Both researchers said they had not provided McNeil such records, citing patient privacy issues.
The agency invited a grieving mother to tell her story at a public hearing. He started to feel sick and started on Theraflu — apparently not realizing that it, too, contained acetaminophen.
Soon, Marcus felt bad enough to check himself into a hospital, where he lapsed into a coma. Eight days after Marcus entered the hospital, Kate and her husband decided to end life support. It was total shock, walking around in a daze, not knowing, angry at God, angry at everything.
The Trunks sued McNeil and settled for an undisclosed amount. McNeil did not respond to questions about the case. When the Trunks took their concerns to the FDA hearing, Kate was so nervous that her husband kept checking her blood pressure.
But she delivered a call to action: She wanted acetaminophen clearly labeled to warn that the drug could poison and even kill. The committee recommended adding a warning aimed at all users, not just drinkers, that overdosing can damage the liver. This time, McNeil gave ground, agreeing with the need for a liver warning. In , the agency launched a modest public service advertisement initiative.
Because too much can damage your liver. A key problem the campaign hoped to address: double dipping, or overdosing by inadvertently taking more than one medication that contains acetaminophen. That risk had grown as McNeil and its competitors expanded the number of acetaminophen products on drugstore shelves. The drug was in medications targeted at consumers suffering all manner of ills, from colds to arthritis aches to insomnia caused by pain.
McNeil wanted the FDA to include warnings about other over-the-counter pain relievers, arguing that they posed risks at least as serious as acetaminophen. McNeil did not respond directly to questions about its opposition to the campaign. But it stressed that it had launched numerous acetaminophen safety education efforts , both on its own and with industry and government partners. Although the agency had prevailed, its safety initiative fizzled. Major media outlets were reluctant to run the public health announcements.
Thirty-five percent of respondents said it was safe to take the maximum recommended dose of Extra Strength Tylenol with NyQuil, a cold remedy that also contains acetaminophen. The margin of error was 3. Officials reviewed the science, the reports of deaths and side effects, and the long history of regulatory delays.
Officials concluded that deaths from acetaminophen poisoning had risen dramatically over the decade between and They zeroed in on how the drug differed from other over-the-counter pain relievers.
The report also suggested removing an entire class of pediatric products to reduce the potential for dosing mix-ups. At the same time, the FDA officials who wrote the report gave a candid assessment of the fierce resistance they expected from drug makers to certain proposals.
In June , the agency gathered nearly 40 experts in a Maryland Marriott to weigh in on its recommendations. Everyone in the room, including executives from McNeil and other companies, knew the stakes. Kuffner objected to dropping the daily recommended dose below 4 grams.
He suggested directing consumers to take one pill at a time until they felt pain relief, gradually easing up to a maximum of 4 grams a day only as necessary. When it came time to vote, Judith Kramer, a physician and professor of medicine at Duke University, reminded her fellow panelists of the opportunity before them, noting that attempts to make acetaminophen safer had foundered for decades.
These conditions frequently can overshadow the public health considerations. And I think that we can't let that happen. Four years later, the agency has not enacted any of its own suggestions for over-the-counter acetaminophen.
In interviews, FDA officials acknowledged that it has taken longer than it should. They blamed a combination of science and bureaucracy.
Despite 50 years of sales and more than 30, published papers, there remain unknowns about acetaminophen. A Canadian government study found six people had suffered serious liver damage after taking less than the maximum recommended dose.
By contrast, a case report described a man who survived after ingesting as much as 60 grams all at once. In response to questions, McNeil first wrote in an email that 8 grams, or double the maximum daily dose, over several days can damage the liver. Later, when asked to confirm this figure, the company declined to do so.
It pointed to data showing that at least 10 grams a day for at least 2 to 3 days can threaten the liver. The agency said that the procedure it set back in the s for revising rules for older drugs "was not rapid, but there were many fewer steps to the process that today is long.
For prescription drugs, the FDA can act more swiftly, and it has limited the amount of acetaminophen in such medicines. In , the FDA limited the amount of acetaminophen that can be put in prescription drugs to milligrams per pill, and gave companies until January to implement the change.
Yet the agency continues to allow the sale of over-the-counter pills that contain up to milligrams of acetaminophen — twice as much. The label for the over-the-counter version of the drug, taken by far more Americans, mentions neither of those potential consequences.
Tylenol with Codeine No. Tylenol 3, as it is commonly known, carries a black box warning about acetaminophen, and each pill contains milligrams, less than the new limit of milligrams. By contrast, a single pill of Extra Strength Tylenol — sold at newsstands, gas stations and big-box retailers across the land — delivers milligrams of acetaminophen. The bottle carries no black box warning. Two pills, containing the same medication, made by the same corporation, carrying the same brand name, regulated by the same agency — but subject to different standards.
While the FDA remains stuck on rules for over-the-counter acetaminophen, McNeil has reversed course on one major proposal. Just a month after adamantly opposing dosing reductions at the advisory committee meeting, McNeil wrote top FDA officials, offering a plan that recognized the will of the advisory committee. Although the company had insisted for half a century that 4 grams of medicine per day was the most appropriate dose for pain relief, the company said it was ready to recommend taking no more than 3 grams a day or six pills of its flagship product, Extra Strength Tylenol.
The company implemented the change in The move echoed other instances, such as the alcohol warning, in which the company opposed safety proposals until the FDA signaled its intent. Then the company adopted measures voluntarily as the agency plodded toward final rules. In Canada and other countries, the company still instructs users of Extra Strength Tylenol that they can take up to 4 grams a day — eight pills. The FDA had said it would issue proposed rules for over-the-counter acetaminophen by the end of August.
But the agency missed that deadline, pushing it back to December. In many other countries, authorities have taken a very different approach to regulating acetaminophen. At least 10 other industrialized countries — including Australia, New Zealand, Germany, Finland, Denmark, Sweden and Switzerland — have placed some kind of restrictions on the drug, a FDA report said. Most limit how much can be sold at one time or require pharmacies to be the only outlets that carry it.
Some European countries with strict regulations have remarkably few deaths. Any of those combinations can overwhelm the liver and be lethal, said George Fredericks , pharmacy director at Albany Memorial, Samaritan and St. Mary's hospitals. But attempted suicide accounts for twice as many liver injuries as accidental overdoses, according to the U.
Centers for Disease Control and Prevention. Acetaminophen is not usually used for recreational purposes. Allen Stefane , medical director of child and adolescent psychiatry at Ellis Hospital in Schenectady. Symptoms of acetaminophen overdose include abdominal pain, nausea and vomiting, among others. But they often don't appear for 24 hours, Long said. Acetaminophen "has to be metabolized by the liver, and you have to overwhelm the body's ability to break it down. Once that happens, you don't start to have symptoms until you have liver damage," Long said.
During a staggered overdose, the drug likely builds up in the liver and kills the cells, Simpson said. Staggered overdose patients may have fared less well because they did not receive the appropriate treatment soon enough, or because they had been drinking alcohol along with acetaminophen, he said.
The new study "sheds light on the fact that the maximum recommended daily dose should be strictly adhered to," said Dr. Acetaminophen also appears in combination with other drugs in certain prescription products. In January the Food and Drug Administration asked all manufacturers of acetaminophen to lower the dose in a single tablet to mg.
Even at this dose, patients who took two tablets every four hours for 24 hours would be at risk for a staggered overdose, Lenchus said. Doctors need to consider the possibility of overdoses when patients come to the hospital after taking acetaminophen, even if the patients have not obviously taken many pills at once, Lenchus said.
This triggers a chain of reactions that can lead to death. According to a literature review, liver failure caused by acetaminophen overdose causes death in approximately 28 percent of cases. Among those who have liver failure, 29 percent require a liver transplant. Those who survive an acetaminophen overdose without needing a liver transplant may experience long-term liver damage. In general, adults can take between milligrams mg and 1, mg of acetaminophen every 4 to 6 hours.
The chart below contains more detailed dosage information for adults based on the type of product and the amount of acetaminophen per dose. For children, the dose varies according to weight. If your child is under the age of 2, ask your doctor for the correct dose.
In general, children can take around 7 mg of acetaminophen per pound of their body weight every 6 hours. Call or poison control right away if you suspect you, your child, or someone you know took too much Tylenol. Early treatment is associated with lower mortality rates in both children and adults. Treatment for a Tylenol or acetaminophen overdose depends on how much was taken and how much time has passed.
If less than an hour has passed since the Tylenol was ingested, activated charcoal may be used to absorb the remaining acetaminophen from the gastrointestinal tract.
When liver damage is likely, a drug called N-acetyl cysteine NAC may be given orally or intravenously. When used as directed, Tylenol is safe for most people. However, you should speak to your healthcare provider before using Tylenol if you have any of the following conditions:.
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