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Health & Fitness (231)
The Centers for Disease Control and Prevention released the number Monday to spotlight the growing threat of germs that are hard to treat because they've become resistant to drugs.
Finally estimating the problem sends "a very powerful message," said Dr. Helen Boucher, a Tufts University expert and spokeswoman for the Infectious Diseases Society of America. "We're facing a catastrophe."
Antibiotics like penicillin and streptomycin first became widely available in the 1940s, and today dozens are used to kill or suppress the bacteria behind illnesses ranging from strep throat to the plague. The drugs are considered one of the greatest advances in the history of medicine, and have saved countless lives.
But as decades passed, some antibiotics stopped working against the bugs they previously vanquished. Experts say their overuse and misuse have helped make them less effective.
In a new report, the CDC tallied the toll of the 17 most worrisome drug-resistant bacteria. The result: Each year, more than 2 million people develop serious infections and at least 23,000 die.
Of those, the staph infection MRSA, or methicillin-resistant Staphylococcus aureus, kills about 11,000, and a new superbug kills about 600. That bacteria withstand treatment with antibiotics called carbapenems - considered one of the last lines of defense against hard-to-treat bugs.
Germs like those have prompted health officials to warn that if the situation gets much worse, it could make doctors reluctant to do surgery or treat cancer patients if antibiotics won't protect their patients from getting infections.
"If we're not careful, the medicine chest will be empty" when doctors need infection-fighting drugs, said CDC Director Dr. Tom Frieden.
It's not clear that the problem is uniformly growing worse for all bugs. Some research suggests, for example, that MRSA rates may have plateaued and a separate CDC report released Monday in JAMA Internal Medicine found that serious MRSA infections declined 30 percent between 2005 and 2011.
MRSA bacteria have been the target of many hospital infection control efforts. These germs often live without symptoms on the skin, but also can cause skin or tissue infections, and become more dangerous when they enter the bloodstream.
Serious, invasive MRSA declined in all settings for a total of 80,461 infections in 2011, the journal report found. Most were linked with health care in people who'd recently been hospitalized or received other medical treatment. But for the first time, the more than 16,000 infections picked up in community settings outnumbered the 14,000 infections that began in the hospital.
A 2005-2010 study in the same journal suggests that pig manure might be a cause of some mostly less serious MRSA infections in people living near fertilized farm fields.
The study is based on patients from Danville, Pa.-based Geisinger Health System. It offers only circumstantial evidence, but the authors said the MRSA link is plausible because antibiotics are widely used on pig farms and other livestock operations to enhance animal growth, and the drugs are found in pig manure.
The study involved nearly 3,000 MRSA cases, about half of them not linked with health-care. The authors estimated that living near pig manure-fertilized fields may have accounted for about 11 percent of MRSA not linked with health care.
But how the germs might spread from pig manure to people with no close animal contact is uncertain, the study authors said. Close contact with an infected person or sharing personal items used by an infected person is the usual way MRSA spreads.
Dr. William Schaffner, a Vanderbilt University infectious disease specialist, called the report "very provocative" but inconclusive.
Asked generally about antibiotic use in farm animals, the CDC's Frieden said it's an important problem, but he added, "Right now the most acute problem is in hospitals and the most resistant organisms are in hospitals."
Tanner contributed to his report from Chicago.
JAMA Internal Medicine: HTTP://JAMAINTERNALMEDICINE.COM
WASHINGTON (AP) — Michelle Obama has pushed America to eat healthier and to exercise more. Now she says we should "drink up" too. As in plain water. And as in more of it.
She's getting behind a campaign being announced Thursday by the Partnership for a Healthier America to encourage people to drink more water.
Organizers say too many people don't drink enough water daily and about one-fourth of kids below age 19 don't drink any water at all on any given day.
The first lady launched an initiative in 2010 to tackle childhood obesity. In the past, she has advocated switching from sugary sodas to water. But officials behind this new effort say it's strictly about getting people to drink more water — not about promoting water over other beverages.
More than 100 nonprofits and related organizations, which specialize in everything from running soup kitchens to organizing farm workers, have been recruited by the federal government to sign up "navigators" to help the 30 million uninsured people who can now gain coverage.
Many of the groups have little expertise in health insurance. And the timeline for training the workers is tight. According to the new health law, people can begin shopping among the new policies on Oct. 1. The enrollment period lasts six months. Coverage begins in January.
"I think there's a lot of concern about whether, with all these state requirements, they are going to be ready to go," said Katie Keith, a former research professor at Georgetown University, who has been tracking the heath care legislation. "You want people out there educating consumers."
Deploying the guides for the uninsured is one of the first hurdles for the new health system as it transitions from an abstract political debate in Washington to a real-life process in communities. It is one of the steps government officials are concerned about as critics warn that the Affordable Care Act could become a "train wreck."
The guides will be sent to community events with laptops to help people sign up for insurance online. They will work at food banks, shelters, churches and free clinics where the uninsured are likely to be.
The short time available for training raises questions about how prepared the workers will be to answer people's questions about the different policies and government subsidies available. Community groups received the course materials for the 20-hour training only days ago. Many have just begun to post the openings on job boards.
A small scream came from Tara McCollum Plese when she was asked whether her group, Arizona Alliance for Community Health Centers, has hired any of the 45 workers authorized in its federal grant. "Ack! No," she said Thursday. Her group has posted a job description, she said, and is now flooded with inquiries for the positions, which pay about $15 an hour. She's since heard one worker has been hired.
Not one navigator has been hired yet under the $2 million grant obtained by the Ohio Association of Foodbanks. The Illinois Eye Institute, which will help with enrollment in the Chicago area, plans to train a dozen staffers for the task.
The work will be more difficult than what most other temporary employees, such as census workers, do. The navigators must listen to a family's real-world story, assess its income, and figure out eligibility for the Medicaid program, which provides health care for the poor, or for new tax credits, each with its own complicated rules.
If the system works as federal officials hope, more than half of the nation's uninsured, which amount to 15 percent of the population, will get coverage.
In Texas, with the highest percentage of uninsured residents, eight groups are receiving a total of $10.8 million and plan to train more than 150 paid workers and volunteers. Tim McKinney, CEO of United Way of Tarrant County, which got the largest grant, said many people without insurance are looking for information.
In Mississippi, workers will go into rural areas without Internet access to help people with the enrollment and policy-shopping process, which is done online.
"When Oct. 1 rolls around, we're going to be ready to rock 'n' roll," said the Rev. Michael O. Minor of Oak Hill Baptist Church in Hernando, Miss.
In 17 states, navigators have additional hoops to jump through because of new state laws affecting the federal health care law, such as required background checks for the workers.
Republican members of the House Committee on Energy and Commerce have also called on some of the assisting groups to explain how consumers will be protected when they speak with a navigator. The Republicans' letter sets a Sept. 13 deadline for the groups to produce documents.
"This request threw us for a loop quite honestly," said Plese of the Arizona health center group. "We haven't even drawn down any funds from the grant."
Will there be enough time for the hiring and training?
"It has to be enough time," said Laura Goodhue, executive director of Florida CHAIN, a consumer health group involved in the training. "We have to do what we have to do."
--- AP writer Ann Sanner contributed to this report from Columbus, Ohio.
--- AP Medical Writer Carla K. Johnson can be reached at HTTP://WWW.TWITTER.COM/CARLAKJOHNSON .
The Albert and Mary Lasker Foundation announced the recipients of the $250,000 prizes on Monday. The awards will be presented Sept. 20 in New York City.
The Gateses won the public service award "for leading a historic transformation in the way we view the globe's most pressing health concerns and improving the lives of millions of the world's most vulnerable," the Lasker foundation said.
They have donated more than $26 billion to their philanthropic foundation. They often team up with agencies that can provide diverse expertise, the Lasker foundation said, noting that they supported an international partnership that has helped immunize hundreds of millions of children against killer diseases. Their current priorities include polio, agriculture and family-planning information and services.
The Lasker clinical medical research award will be shared by Graeme Clark, an emeritus professor at the University of Melbourne in Australia, Ingeborg Hochmair of the company MED-EL in Innsbruck, Austria, and Blake Wilson of Duke University in North Carolina, for developing the modern cochlear (KAH'-klee-er) implant. More than 320,000 people around the world use the implants for severe hearing loss, the foundation said.
The devices stimulate the auditory nerve with electric signals. Hochmair and Clark worked independently, in the face of scientific skepticism that electrical stimulation could produce meaningful hearing. The implants were approved in the U.S. in 1985.
Wilson later designed a new way for implants to process speech, which has allowed most users to understand words and sentences with no visual cues. The advance fueled a growth in implant use that began in the early 1990s, the foundation said.
The Lasker award for basic medical research will be shared by Richard Scheller of the biotech company Genentech and Dr. Thomas Sudhof of Stanford University. With research they began independently in the late 1980s, they unraveled details of how brain cells release chemical messengers to communicate with each other. Scientists are beginning to find connections between the molecular equipment they studied and serious illnesses like Parkinson's disease, the foundation said.
A study released Thursday by the nonprofit Kaiser Family Foundation found that government tax credits would lower the sticker price on a benchmark "silver" policy to a little over $190 a month for single people making about $29,000, regardless of their age.
By pairing their tax credit with a stripped-down "bronze" policy, some younger consumers can bring their premiums down to the range of $100 to $140 a month, while older people can drive their monthly cost even lower - well below $100 - if they are willing to take a chance with higher deductibles and copays.
A separate study released Wednesday from Avalere Health, a private data analysis firm, took a wide-angle view, averaging the sticker prices of policies at different coverage levels.
Before tax credits that act like a discount, premiums for a 21-year-old buying a mid-range "silver" policy would be about $270 a month, the Avalere study found. List-price premiums for a 40-year-old buying a mid-range plan will average close to $330. For a 60-year-old, they were nearly double that at $615 a month.
Starting Oct. 1, those who don't have health care coverage on the job can go to new online insurance markets in their states to shop for a private plan and find out if they qualify for a tax credit. An estimated 4 out 5 consumers in the new markets will be eligible for some level of tax credit.
Come Jan. 1, virtually all Americans will be required to have coverage, or face fines. At the same time, insurance companies will no longer be able to turn away people in poor health.
The Obama administration, which is running the markets or taking the lead in 35 states, is not expected to release final premiums until close to the Oct. 1 launch date. But the two private studies provide an early look at the emerging market.
Caroline Pearson, lead author of the Avalere study, said it will be competitive, but there will be big price differences among age groups, states and even within states.
The bottom line is mixed: Many consumers will like their new options, particularly if they qualify for a tax credit. But others may have to stretch to afford coverage.
"We are seeing competitive offerings in every market if you buy toward the low end of what's available," said Pearson, a vice president of Avalere.
However, for uninsured people who are paying nothing today, "this is still a big cost that they're expected to fit into their budgets," Pearson added.
The Obama administration said consumers will have options that are cheaper than the averages presented in the Avalere study. "We're consistently seeing that premiums will be lower than expected," she said. "For the many people that qualify for a tax credit, the cost will be even lower."
The Kaiser study found that while premiums will vary significantly across the country, they are generally coming in lower than forecast by the government's own experts. It cautioned against comparing premiums under Obama's law to what individually insured people currently pay, because the new coverage is more robust.
Avalere crunched the numbers on premiums filed by insurers in 11 states and Washington, D.C. Kaiser analyzed 17 states and the District of Columbia. Both studies included a mix of states running their own insurance markets and ones in which the federal government will take charge.
The states analyzed by Avalere were California, Connecticut, Indiana, Maryland, New York, Ohio, Rhode Island, South Dakota, Vermont, Virginia and Washington.
In addition to those, Kaiser included Colorado, Maine, Montana, Nebraska, New Mexico and Oregon.
No data on premiums were publicly available for Texas and Florida - together they are home to more than 10 million of the nation's nearly 50 million uninsured people - and key to the law's success.
However, Pearson said she's confident the premiums in the Avalere study will be "quite representative" of other states, because clear pricing patterns emerged.
Four levels of plans will be available under Obama's law: bronze, silver, gold and platinum. Bronze plans will cover 60 percent of expected medical costs; silver plans will cover 70 percent; gold will cover 80 percent and platinum 90 percent.
All plans cover the same benefits, but bronze features the lowest premiums, paired with higher deductibles and copays. Platinum plans would have the lowest out-of-pocket costs and the highest premiums.
Mid-range silver plans are considered the benchmark, because the tax credits will be keyed to the cost of the second-lowest-cost silver plan in a local area.
And there's another important detail for consumers to be aware of: People with modest incomes may come out ahead by sticking with a silver plan instead of going for the lower premiums with bronze. Additional help with out-of-pocket costs like copays will only be available to people enrolling in a silver plan.
Although the sticker price for premiums rises dramatically above age 40, the tax credits are shaping up as a powerful equalizer for older consumers. That's because they work by limiting what you pay for premiums to a given percentage of your income.
For example, someone making $23,000 would pay no more than 6.3 percent of his or her annual income - $1,450 - for a benchmark silver plan. The amount you pay stays the same whether the total premium is $3,000 or $9,000.
However, those tax credits taper off rapidly for people with solid middle-class incomes, above $30,000 for an individual and $60,000 for a family of four.
The Avalere study also found some striking price differences within certain states, generally larger ones. In New York, with 16 insurers participating, the difference between the cheapest and priciest silver premium was $418.
WASHINGTON (AP) — Flu vaccination is no longer merely a choice between a jab in the arm or a squirt in the nose. This fall, some brands promise a little extra protection.
For the first time, certain vaccines will guard against four strains of flu rather than the usual three. Called quadrivalent vaccines, these brands may prove more popular for children than their parents. That's because kids tend to catch the newly added strain more often.
These four-in-one vaccines are so new that they'll make up only a fraction of the nation's supply of flu vaccine, so if you want a dose, better start looking early.
But that's only one of an unprecedented number of flu vaccine options available this year.
Allergic to eggs? Egg-free shots are hitting the market, too.
Plus there's growing interest in shots brewed just for the 65-and-older crowd, and a brand that targets the needle-phobic with just a skin-deep prick.
"We're moving away from the one-size-fits-all to choosing the best possible vaccine for an individual's age and condition," said Dr. Gregory Poland, an infectious disease specialist at the Mayo Clinic.
"The flip side of that," he said, is that "this will be a confusing year" as doctors and consumers alike try to choose.
Federal health officials recommend a yearly flu vaccine for nearly everyone, starting at 6 months of age. On average, about 24,000 Americans die each flu season, according to the Centers for Disease Control and Prevention.
Some questions and answers about the different vaccine varieties to choose from:
Q: What's the difference between those new four-strain vaccines and the regular kind?
A: For more than 30 years, the vaccine has offered protection against three influenza strains — two common Type A strains called H1N1 and H3N2, and one strain of Type B. Flu strains continually evolve, and the recipe for each year's vaccine includes the subtypes of those strains that experts consider most likely to cause illness that winter.
Type A flu causes more serious disease and deaths, especially the H3N2 form that made last year such a nasty flu season. But the milder Type B flu does sicken people every year as well, and can kill. Two distinct Type B families circulate the globe, making it difficult to know which to include in each year's vaccine. Adding both solves the guesswork, and a CDC model estimates it could prevent as many as 485 deaths a year depending on how much Type B flu is spreading.
Q: How can I tell if I'm getting the four-strain vaccine?
A: All of the nasal spray version sold in the U.S. this year will be this new variety, called FluMist Quadrivalent. The catch is that the nasal vaccine is only for healthy people ages 2 to 49 who aren't pregnant.
If you prefer a flu shot, ask the doctor or pharmacist if the four-strain kind is available. Younger children, older adults, pregnant women and people with chronic health conditions all can use flu shots. Four-strain versions are sold under the names Fluzone Quadrivalent, Fluarix Quadrivalent and FluLaval Quadrivalent.
Manufacturers anticipate producing between 135 million and 139 million doses of flu vaccine this year. Only about 30 million doses will offer the four-strain protection.
Q: Who should seek it?
A: Type B flu tends to strike children more than the middle-aged, Poland noted. And he said it's not a bad idea for seniors, who are more vulnerable to influenza in general. But the CDC doesn't recommend one vaccine variety over another, and the American Academy of Pediatrics said either kind is fine — just get vaccinated.
Q: How are these new vaccines different from the high-dose flu shot for seniors?
A: Fluzone High-Dose protects against the traditional three strains of flu, but it quadruples the standard vaccine dose in an effort to rev up age-weakened immune systems don't respond as actively to regular flu shots.
The government calls the high-dose shot an option for seniors, not one that's proved better. Last week, Sanofi Pasteur said initial results from a study of 30,000 seniors vaccinated over the past two flu seasons suggest the high-dose shot is about 24 percent more effective. Federal health officials will have to review the full study results to see if they agree.
Q: What if I'm allergic to eggs?
A: Traditional flu vaccine is made from viruses grown in eggs, and specialists say it's usually not a problem unless someone has a serious egg allergy. But the new FluBlok vaccine eliminates that concern because it is made with cell technology, like many other nonflu vaccines. So far, it's only for use in people ages 18 to 49.
Q: What if I'm scared of needles?
A: If you don't qualify for the ouchless nasal spray vaccine, there is one shot made with a teeny-tiny needle that pricks the skin instead of muscle. Called Fluzone Intradermal, it's available for 18- to 64-year-olds, and protects against the usual three strains.
Q: How soon should I be vaccinated?
A: Early fall is ideal, as it's impossible to predict when flu will start spreading and it takes about two weeks for protection to kick in. But later isn't too late; flu season typically peaks in January or February.
Q: How much does flu vaccine cost?
A: The vaccine is covered by insurance, and Medicare and some plans don't require a copay. Drugstore vaccination programs tend to charge about $30; expect the quadrivalent versions to be slightly more expensive.
Johnson & Johnson says the warning will appear on the cap of new bottles of Extra Strength Tylenol sold in the U.S. starting in October and on most other Tylenol bottles in coming months. The warning will make it explicitly clear that the over-the-counter drug contains acetaminophen, a pain-relieving ingredient that is the nation's leading cause of sudden liver failure.
"We're always looking for ways to better communicate information to patients and consumers," says Dr. Edwin Kuffner, vice president of McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol.
Overdoses from acetaminophen send 55,000 to 80,000 people in the U.S. to the emergency room each year and kill at least 500, according to the Centers for Disease Control and Prevention and the Food and Drug Administration. Acetaminophen can be found in more than 600 over-the-counter and prescription products used by nearly one in four American adults every week, including household brands like Nyquil cold formula, Excedrin pain tablets and Sudafed sinus pills.
Tylenol is the first of these products to include such a warning label on the bottle cap. McNeil says the warning is a result of research into the misuse of Tylenol by consumers. The new cap message will read: "CONTAINS ACETAMINOPHEN" and "ALWAYS READ THE LABEL."
The move comes at a critical time for the company, which faces more than 85 personal injury lawsuits in federal court that blame Tylenol for liver injuries and deaths. At the same time, the Food and Drug Administration is drafting long-awaited safety proposals that could curtail the use of Tylenol and other acetaminophen products.
Much is at stake for McNeil and its parent company. Johnson & Johnson does not report sales of Tylenol, but total sales of all over-the-counter medicines containing acetaminophen were more than $1.75 billion last year, according to Information Resources Inc., a retail data service.
Safety experts are most concerned about "extra-strength" versions of Tylenol and other pain relievers with acetaminophen found in drugstores. A typical two-pill dose of Extra Strength Tylenol contains 1,000 milligrams of acetaminophen, compared with 650 milligrams for regular strength. Extra Strength Tylenol is so popular that some pharmacies don't even stock regular strength.
Most experts agree that acetaminophen is safe when used as directed, which generally means taking 4,000 milligrams, or eight pills of Extra Strength Tylenol or less, a day.
Each year, some 100 million Americans use acetaminophen, but liver damage occurs in only a fraction of 1 percent of users. Still, liver specialists say those cases are preventable. Part of the problem, they say, is that there are sometimes hundreds of pills in a bottle, making it easy for consumers to pop as many as they please. For example, McNeil sells Extra Strength Tylenol in bottles containing up to 325 tablets
"The argument goes that if you take acetaminophen correctly you will virtually never get into trouble," says Dr. William Lee of the UT Southwestern Medical Center, who has studied acetaminophen toxicity for four decades. "But it's the very fact that it's easily accessible over-the-counter in bottles of 300 pills or more that puts people in harm's way."
Lee applauded the new warning, but said McNeil's marketing has contributed to the "freewheeling" way that Americans take the drug. For decades, McNeil has advertised Tylenol as "the safest kind of pain reliever" when used as directed. "That has been their standard ploy in the past, and I would argue that safest it is not," he says.
McNeil's Kuffner stands by the company's safety claim: "When taken as directed, when people read and follow the label, I believe that Tylenol and the acetaminophen ingredient is one of the safest pain relievers on the market."
McNeil is the only major drugmaker adopting the bottle cap warning at this time, according to the Consumer Healthcare Products Association, a trade group for over-the-counter medicine companies.
"While this is not an industrywide initiative at this time, it fits squarely within the many ongoing industrywide educational initiatives to further acetaminophen safe and responsible use by consumers," said Emily Skor, a vice president with the trade group, which represents McNeil, Bayer Healthcare, Procter & Gamble and other nonprescription drugmakers.
20 YEARS OF WARNINGS
McNeil has updated the safety warnings on Tylenol periodically since the 1990s.
In 1994, the company added a warning about the risk of liver damage when combining alcohol with Tylenol following a lawsuit brought by Antonio Benedi, a former aide to President George H.W. Bush, who fell into a coma and underwent emergency liver transplant after mixing Tylenol with wine at dinner.
A jury awarded him $8.8 million in damages after concluding that McNeil failed to warn consumers about the risk. The FDA made the alcohol warning mandatory for all manufacturers of acetaminophen in 1998.
Then, in 2002, an expert panel of FDA advisers recommended that the government agency require all acetaminophen products to carry a warning about the risk of "severe liver damage" when not taken as directed. The group's votes are non-binding, though the FDA usually follows them. McNeil voluntarily added the warning to its products in 2004, five years before the FDA made it mandatory.
Today, McNeil appears to be moving ahead of regulators again. In 2009, the FDA assembled another expert panel to consider more sweeping changes to reduce acetaminophen overdoses. The panel recommended a half-dozen major changes, including lowering the maximum nonprescription daily dose for adults. McNeil voluntarily adopted that recommendation, lowering the recommended adult dose of Extra Strength Tylenol to 3,000 milligrams per day, or six pills of Extra Strength Tylenol, down from 4,000 milligrams per day, or eight pills. The label stipulates that patients can still take a higher dose under doctor's directions.
But the company has not embraced a more drastic recommendation by the FDA's expert panel: eliminating the over-the-counter "extra-strength" formulation altogether, which would mean lowering the acetaminophen dose from 1,000 milligrams to 650 milligrams, or two tablets of 325 milligrams each. The panel said the 1,000 milligram dose should only be available via prescription.
McNeil argues that the lower dose is less effective and could drive people to take anti-inflammatory pain relievers, a different class of drugs that includes aspirin and ibuprofen. Those medicines can cause stomach ulcers and dangerous gastrointestinal bleeding.
FDA spokeswoman Erica Jefferson says the agency is actively working on new rules for both children and adult acetaminophen products. While the agency won't give a timeframe for completion, the federal government's website that tracks new regulations lists December as the target date for publishing the proposed rules.
As early as 1977, FDA advisers recommended adding more warnings to the acetaminophen label about liver damage, but the agency didn't require the language until 2009.
"They are very slow to respond to these things and it's always a little frustrating," says Dr. Lewis Nelson of New York University, who chaired the 2009 FDA panel.
ANATOMY OF AN OVERDOSE
Experts first identified acetaminophen overdose as a major public health concern in the 1990s, but it has taken years to form a clearer picture of the problem.
Acetaminophen overdoses occur when the liver is overwhelmed by too much of the drug, producing a toxic byproduct that kills liver cells. Liver failure occurs when most cells are no longer able to function. At that point, a patient then generally has 24 to 48 hours to live without a transplant.
Of the roughly 500 acetaminophen deaths reported annually, about half are accidental, with the rest deemed suicides. About 60 percent of the unintentional overdoses involve prescription opioid-acetaminophen combination drugs such as Percocet and Vicodin, according to a database of liver failure cases run by Dr. Lee at the Southwestern Medical Center in Dallas. Those two products alone were prescribed more than 173 million times last year, according to IMS Health.
So how do these accidental acetaminophen deaths occur? Imagine you've had major dental surgery, and your dentist prescribes a five-day supply of Percocet. You take the recommended two pills every six hours for 2,600 milligrams of acetaminophen, well below the 4,000-milligram-a-day safety threshold.
But you're still experiencing pain, so you decide to add Extra Strength Tylenol, six caplets a day for another 3,000 milligrams. Now you're feeling better but you still have trouble sleeping, so you take Nyquil, for another 650 milligrams. After a few days on this 6,250 milligram regimen, experts say acute liver damage is a real risk.
The labels on all of these products warn against mixing them. But researchers say many consumers either don't read or don't understand such warnings.
Even after taking into account people who ignore labels, there are still cases of liver damage that stump researchers. These are the people who have apparently taken about 4,000 milligrams a day or less, well within the safety threshold.
"It's still a little bit of a puzzle," says Dr. Anne Larson, of the Swedish Medical Center in Seattle. "Is it genetic predisposition? Are they claiming they took the right amount, but they really took more? It's difficult to know."
The question is critical in the lawsuits piling up against McNeil in the Eastern District of Pennsylvania, near McNeil's headquarters in Fort Washington, Pa. Virtually all of the 85 cases claim that the plaintiffs suffered liver failure despite taking Tylenol as directed.
According to one of those complaints, Madeline Speal, of Salzburg, Pa., took Tylenol for three days in November 2009 "at appropriate times and in appropriate doses." But on Nov. 28, she was admitted to Latrobe Area Hospital with catastrophic liver damage. She was then transferred to the University of Pittsburgh Medical Center where she underwent an emergency liver transplant.
The cases against McNeil, which share the same legal wording, allege that the company risked the lives of consumers by making "conscious decisions not to redesign, re-label, warn or inform the unsuspecting consuming public."
The lawsuits have been consolidated under a single federal judge to streamline the pretrial process, though they will eventually be returned to judges in their original districts for trial.
J&J and McNeil continue to reiterate that Tylenol is safe. "We remain confident in the safety and efficacy of Tylenol products, which rightfully have been trusted by doctors, hospitals and consumers for more than 50 years," McNeil said in a statement.
But lawyers for the patients suing McNeil say Tylenol can still be dangerous even when used at or just above recommended levels.
"Products that are available to consumers should have a reasonable margin of safety," said Laurence Berman, one of several attorneys representing Tylenol users.