15 May 2010

Spouses of Dementia Patients More Likely to Develop the Disease Too

The Detroit Free Press

Married adults who have a spouse with dementia are much more likely themselves to develop dementia, according to a study published last week in the Journal of the American Geriatrics Society.

The study suggested that either the stress of being a caregiver or something about the shared environment of the couple contributes to the second case of dementia.

Researchers from Utah examined 2,442 married people ages 65 and older, none of whom had dementia at the start of the study. They were monitored for 12 years.

During that time, 125 cases of dementia were diagnosed in husbands and 70 cases in wives and 30 cases in which both the husband and wife were diagnosed. The analysis showed that people with a spouse with dementia had a six times higher risk of developing dementia themselves. The risk, however, was much higher for men caring for their wives than for wives caring for their husbands.

"On the positive side, the majority of these individuals with spouses who develop dementia did not themselves develop dementia," said lead author of the study, Dr. Maria Norton of Utah State University.

09 May 2010

When Autism Begins may Dictate how Severe Illness will be

The Detroit Free Press

Among the most baffling observations about autism is that some children appear to have symptoms early in life while others develop normally and then regress before they reach their third birthday.

Still others have mild developmental delays and then experience a plateau in development.

Evidence suggests these are different types of autism. Researchers at Kennedy Krieger Institute in Baltimore found in a new study that children with early symptoms may actually be at lower risk for poorer outcomes than children who develop normally and then experience a loss of skills.

In data collected from 2,720 parents, researchers found that children with regression had a distinct increase in the severity of symptoms, such as not attaining conversational speech. The outlook was even worse for children whose parents also said the regression phase was severe.

"Children with developmental plateau are an especially under-researched group, and these findings have important implications for those designing and prioritizing clinical evaluations," a coauthor of the study, Dr. Paul Law, said in a news release.

More than one-third of the parents surveyed said they had concerns about their child's general development before they noticed the more obvious signs of regression.

The study is published online in the Journal of Autism and Developmental Disorders.

08 May 2010

An Alcoholic's Savior - Was it God, Belladonna, or Both

NY Times

 
In October 1909, Dr. Alexander Lambert boldly announced to a New York Times reporter that he had found a surefire cure for alcoholism and drug addiction. Even more astounding, he stated that the treatment required “less than five days.” The therapy consisted of an odd mixture of belladonna (deadly nightshade), along with the fluid extracts of xanthoxylum (prickly ash) and hyoscyamus (henbane). “The result is often so dramatic,” Lambert said, “that one hesitates to believe it possible.”

Dr. Lambert was hardly a quack looking for headlines. He was widely known as Theodore Roosevelt’s personal physician, a professor of medicine at Cornell Medical College and an expert on alcoholism. Dr. Lambert had years of experience taking care of thousands of alcoholics at Bellevue Hospital’s infamous “drunk ward.” In fact, it was on this storied hospital ward where he experimented with the belladonna cure.

He had obtained the recipe from a layman named Charles B. Towns, who, in turn, claimed to have learned about it from a country doctor. In 1901, Mr. Towns opened a substance abuse hospital in New York City at 293 Central Park West, between 89th and 90th Streets. He needed Dr. Lambert because he lacked a medical degree and, hence, professional credibility; Dr. Lambert needed Mr. Towns, because for all his medical knowledge, he had relatively little to offer his patients in terms of an effective treatment.

The Towns Hospital attracted only the wealthiest alcoholics and addicts, who gladly paid exorbitant fees for a treatment that “successfully and completely removes the poison from the system and obliterates all craving for drugs and alcohol.” Because of Prohibition and the paradoxical rise in alcoholism in 1920, the Towns Hospital restricted its practice to drying-out well-to-do alcoholics.

Perhaps the most famous patient was William Griffith Wilson, better known as Bill W., the co-founder of Alcoholics Anonymous. In the early 1930s, Mr. Wilson was consuming more than two quarts of rotgut whiskey daily, a definite health risk according to Alexander Lambert, who found in his copious research that consumers of cheap or bootlegged alcohol were far more prone to seizures, delirium tremens and brain damage than those who drank the expensive stuff. Between 1933 and 1934, at his wife’s urging and on his wealthy brother-in-law’s dime, Mr. Wilson was admitted to Towns four times. The cost upon admission was steep: up to $350 (roughly $5,610 today) for a four- to five-day stay.

Although Mr. Wilson made some progress in temporarily abstaining, he relapsed after each of the first three hospitalizations. It was around this time that he reunited with a drinking buddy named Ebby Thacher. Unlike previous times, when they went out on wild binges, Mr. Thacher told him that he quit booze and was a member of the Oxford Group, a church-based association devoted to living on a higher spiritual plane guided by Christianity. As a demonstration, on Dec. 7, 1934, Mr. Thacher took Mr. Wilson to the Calvary Mission on East 23rd Street and Second Avenue, where the most drunken of New York’s Depression-era down-and-outers went to be fed and, it was hoped, “saved.”

A few days later, a drunken Wilson staggered back into the Towns Hospital. There, his physician, William D. Silkworth, sedated him with chloral hydrate and paraldehyde, two agents guaranteed to help an agitated drunk to sleep, albeit lightly. This was especially important because the medical staff members had to wake patients every hour for at least two days to take the various pills, cathartics and tinctures of the belladonna regime.

On the second or third day of his treatment, Mr. Wilson had his now famous spiritual awakening. Earlier that evening, Mr. Thacher had visited and tried to persuade Mr. Wilson to turn himself over to the care of a Christian deity who would liberate him from the ravages of alcohol addiction. Hours later, depressed and delirious, Mr. Wilson cried out: “I’ll do anything! Anything at all! If there be a God, let him show himself!” He then witnessed a blinding light and felt an ecstatic sense of freedom and peace. When Mr. Wilson told Dr. Silkworth about the event, the physician responded: “Something has happened to you I don’t understand. But you had better hang on to it.”

Hang on to it he did. Indeed, this experience ultimately led Mr. Wilson to abstain from alcohol for the remaining 36 years of his life and to co-create the novel program whereby one alcoholic helps another through a commitment to absolute honesty and a belief that a higher power can help one achieve sobriety.

Long before Mr. Towns touted his cure for alcoholism, belladonna (as well as henbane) was known to cause hallucinations. The hallucinations brought on by alcoholic delirium tremens tend to be a transmogrification of things the alcoholic is actually seeing or experiencing into a realm of sheer terror. A stray coil of rope may appear to be a poisonous cobra; a pattern on the wallpaper seems to transform into a poisonous spider. But they can also be tactile, like the sensation of insects crawling on the skin. Other hallucinations associated with alcohol withdrawal, or alcoholic hallucinosis, tend to be brief and involve hearing accusatory or threatening voices.

Belladonna hallucinations, on the other hand, are typically based on recent discussions the person had but become far more fantastic. Many times, these visions appear to fulfill the wishes one might have had during the inspiring experience.

Several decades after his 1909 announcement, Alexander Lambert took great pains to distance himself from belladonna. Although Dr. Lambert found the detoxification process to be useful in the short run, he became discouraged by its toxicity, its propensity to induce hallucinations and the fact that many of those he treated at Bellevue relapsed and returned for subsequent treatment. Something more was needed, he declared, and that task fell to Bill Wilson and an alcoholic physician from Ohio named Bob Smith, who created Alcoholics Anonymous in 1935.

Were Bill Wilson’s spiritual awakening and influential sobriety the products of a belladonna hallucination shortly after his discussions with his friend Ebby Thacher? Could they have been incited by his alcohol withdrawal symptoms? Or did something else happen to him that science cannot explain? In the end, millions of people who have benefited from Alcoholics Anonymous and similar 12-step alcohol rehab programs  in New York and around the world would say that such pharmacological, physical or spiritual parsing hardly matters.

07 May 2010

DC Passes Medical Marijuana Bill

Associated Press

WASHINGTON — The D.C. Council has passed a measure to legalize medical marijuana, sending the bill to Washington Mayor Adrian Fenty.

Under the measure passed Tuesday, the nation's capital would join 14 states that allow medical marijuana.

Patients with chronic illnesses such as AIDS or cancer could obtain marijuana with a doctor's recommendation. It would be given out at five to eight distribution centers.

Patients would be limited to two ounces of marijuana per month.

If Fenty signs the bill as expected, Congress would have 30 days to review before it becomes law.

In 1998, residents voted to legalize medical marijuana, but Congress blocked the initiative from taking effect for years.


FDA Orders Baxter International to Recall and Destroy Faulty Hospital Pumps

LA Times


 
 
The Food and Drug Administration has ordered Baxter International Inc. to recall 200,000 of the company's Colleague brand pumps, escalating its scrutiny of infusion pumps used primarily in hospitals to deliver fluids to patients.

The FDA said the Deerfield, Ill.-based drug and device maker must "recall and destroy" all of its Colleague pumps, saying the action was based on "a long-standing failure" of the company to correct serious problems with them. Baxter will incur a special pretax charge of $400 million to $600 million in its first quarter to cover the cost of the recall.

The FDA said the Deerfield, Ill.-based drug and device maker must "recall and destroy" all of its Colleague pumps, saying the action was based on "a long-standing failure" of the company to correct serious problems with them. Baxter will incur a special pretax charge of $400 million to $600 million in its first quarter to cover the cost of the recall.

"The situation has languished far beyond what it should have," said Bob Parkinson, Baxter's chairman and chief executive, speaking Tuesday to shareholders attending the company's annual meeting in Deerfield.

Infusion pumps are devices most commonly found in hospitals, delivering fluids, medicine and nutritional liquids via a timing mechanism that controls the amount of medication a patient receives.

The FDA said infusion pumps, including Baxter's Colleague, had caused "persistent safety problems."

In the last five years, the FDA has received more than 56,000 reports of adverse events that included serious injuries and more than 500 deaths. The agency did not say how many adverse events were linked to Baxter's Colleague pump.

On April 23, the FDA launched a new initiative to address infusion pump safety that required manufacturers to perform more tests before the devices are sold. The next week, Baxter rival Hospira of Lake Forest, Ill., said it was ceasing sales of its infusion pump Symbiq after customers complained that the alarm failed "at the end of infusion in certain conditions."

Parkinson said the kind of design improvements the FDA wanted were "close to impossible" for Baxter to accomplish "without fundamentally redesigning the pump."

By the end of last week, the FDA had rejected Baxter's corrective action plan for the Colleague pumps. The agency called the plan "unacceptable" and said it would have allowed the company to keep a device with "known safety concerns" on the market until 2013. The FDA said it was not satisfied with Baxter's timetable for fixing Colleague, a pump the company stopped selling in 2005 because of various design flaws, battery failures and related software issues.

"The FDA has been working with Baxter since 1999 to correct numerous device flaws," the agency said in a statement. "Since then, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors and other issues."

Baxter has been operating under a 2006 consent decree with the FDA that allowed the agency to recall the pumps. Although Colleague pumps remain on the U.S. market, Baxter has not sold or distributed them for five years. In Colleague's last full year on the market, the device generated $170 million in sales.

The medical product giant said it worked with the FDA to minimize disruption to hospitals using the Colleague pumps. The company will be offering healthcare facilities the opportunity to exchange the pumps without charge.

Baxter will offer to exchange its Sigma Spectrum infusion pumps for the Colleague brand. Baxter spokeswoman Erin Gardiner described the Sigma Spectrum as a next-generation "smart pump."

05 May 2010

Stomach Cancer on the Rise Among Young, White Adults

Business Week
Reasons not known, but the trend is worrisome, experts say


While rates of lower stomach cancer continue to decline for most groups in the United States, a new study finds that among young, white men and women the rate is increasing.

The main cause of lower stomach cancer is infection with the bacteria Helicobacter pylori, while cancer in the upper stomach is often caused by acid reflux. Most stomach cancers are found in those aged 65 and older. In the United States, blacks, Asian Americans and Hispanics have the highest rates of stomach cancer, according to the researchers.

"We confirmed what had been previously understood about gastric cancer, that in most groups it has been declining over the last 30 years," said lead researcher Dr. Charles Rabkin, a senior investigator at the U.S. National Cancer Institute.

"We found one exception to that trend, which was that young, white Americans, ages 25 to 39, actually had increasing rates of gastric cancer," he said. "That was an unexpected finding, and a disturbing finding."

The report is published in the May 5 issue of the Journal of the American Medical Association.

For the study, Rabkin's team used data from the National Cancer Institute's Surveillance, Epidemiology and End Results (SEER) program, which identified 39,003 cases of gastric cancer diagnosed from 1977 through 2006.

The researchers compared differences in the rates of stomach cancer over the period by age, race and other factors.

They found that, over 30 years, the rate of lower stomach cancer dropped from 5.9 to 4.0 per 100,000 people among whites, from 13.7 to 9.5 per 100,000 among blacks, and from 17.8 to 11.7 per 100,000 among other racial groups.

However, among whites, although the rates fell for most people, they increased for men and women aged 25 to 39. "The increase is estimated to be about 2.7 percent per year," Rabkin said. "That may sound like a small number, but over a number of years that percentage can grow just like compound interest on a loan."

The primary cause of lower stomach cancer is the bacteria H. pylori. Changes in the infection patterns over the last 50 years might explain the increasing rates of stomach cancer among younger whites, the researchers noted.

In older whites, the drop in lower stomach cancer is consistent with declines in H. pylori infection. This decline in infection is due to improved hygiene and less crowding during childhood, when the infections are often acquired.

"We don't know why the rate of gastric cancer is rising in young whites," Rabkin said.

It could indicate a change in the age when they become infected or an increase in the prevalence of the infection, the researchers added. It is also possible that something else is causing the cancer brought on by the eradication of H. pylori.

Dietary factors, such as eating salt and salt-preserved foods, are also associated with noncardia gastric cancer. Smoking is another risk factor for upper and lower stomach cancers, the researchers noted.

Dr. Jaffer A. Ajani, an oncologist in the Department of Gastrointestinal Medical Oncology at the University of Texas M.D. Anderson Cancer Center and co-author of an accompanying journal editorial, said that "this is a novel finding -- I don't think we need to be alarmed about this."

However, Ajani thinks the trend needs to be investigated. "One possibility is that these are Eastern Europeans, who have come to the United States. Eastern Europeans have gastric cancer in different places," he said.

The trend may be just a blip, which is already disappearing, Ajani said. "My personal opinion is that it is just among Eastern Europeans," he said.

"This probably needs further investigation," noted Dr. Ahmedin Jemal, strategic director for cancer occurrence at the American Cancer Society.

"Anything that occurs in the younger age group indicates a burden in the future," Jemal said. "So, it is important to find out what is contributing to this increase so you can avert the future cancer burden."

In another report in the same journal, researchers with the Global Advanced/Adjuvant Stomach Tumor Research International Collaboration (GASTRIC) Group studied whether surgery alone or in combination with chemotherapy offered the best survival for stomach cancer patients. They looked at 17 clinical trials that included over 3,800 patients. Among 1,857 patients who had surgery, 1,067 died within seven years of the procedure, compared with 1,000 deaths among 1,924 patients who also had chemotherapy.

Oregon Has Lowest Rate of Childhood Obesity

Associated Press

 
What's the magic in Oregon that keeps kids lean? It's a mystery health officials would like to solve as they admit all states are failing — by a mile — to meet federal goals for childhood obesity.

Oregon has the nation's lowest rate of hefty kids, according to a new government study, which found big gaps between regions and ballooning obesity rates in many states from 2003 to 2007.

More than 16 percent of American children ages 10 to 17 years were not just overweight, but obese, in 2007. That's a 10 percent rise from 2003. Mississippi topped the nation with more than a fifth of its kids obese.

Oregon was the star, with the lowest rate of obesity — defined as body mass index in the 95th percentile or above — at just under 10 percent. And Oregon was the only state whose childhood obesity fell significantly from 2003 to 2007.

Even the best states fell short. The federal Healthy People 2010 initiative set a childhood obesity goal of 5 percent. Only Wyoming girls came close to that, according to the study appearing in May's Archives of Pediatrics and Adolescent Medicine.

"You've got such wide differences at the geographic level, which means there is potential to further reduce obesity," said lead author Gopal Singh, an epidemiologist with the U.S. Health Resources and Services Administration.

What works? It's unclear how much states can overcome the effects of poverty, race and family history — all of which have complex links to obesity.

Black and Hispanic young people in the study were twice as likely as whites to be overweight or obese, even when the researchers took into account other risk factors like inactivity and poverty.

Oregon is 90 percent white. It also has a high rate of breast-feeding, and some research suggests that protects against obesity.

Oregon law sets nutrition standards in schools and requires chain restaurants to provide nutritional information on request. Those steps, taken recently, wouldn't have shown up in the new study's results, but may reflect Oregon's inherent interest in health.

The figures for this analysis came from a representative telephone survey of parents who gave information about their children. Figures for about 47,000 children were analyzed for 2003 and about 44,000 children for 2007. That's not as accurate as a government survey that weighs and measures children. Data from that suggest childhood obesity rates nationwide may be starting to stabilize.

In a separate paper based on the same data, Singh found that a child living in a neighborhood with unsafe surroundings, poor housing and no access to sidewalks, parks and recreation centers had 20 to 60 percent higher odds of being obese or overweight.

Experts blame the rise in childhood obesity on fast food, neighborhoods without sidewalks, television, video games, schools neglecting physical education and a host of other societal changes, said Dr. Joe Thompson, director of the Robert Wood Johnson Foundation Center to Prevent Childhood Obesity.

Now, lawmakers must move the obesity numbers in the right direction to save future medical costs, if for no other reason, Thompson said.

04 May 2010

National Physical Activity Plan aims to get Americans moving

USA Today

One day, most kids may jump on their bikes and ride to school.

While they're there, they'll be playing active games in high-caliber physical education classes and doing lots of fun recreational activities before and after school.

Adults should be able to walk, bike or jog to work, the grocery store or a local park or community recreation center, where they will be able play golf or tennis or take exercise classes.

And doctors may talk to their patients about an important new "vital sign" — their physical activity level.

These are among the goals that could be achieved with comprehensive, wide-ranging strategies outlined in the new U.S. National Physical Activity Plan, which is being released today by an expert panel representing influential health organizations. Among groups involved are the Centers for Disease Control and Prevention, the American College of Sports Medicine, the American Heart Association and the American Cancer Society.

The purpose: to create an environment in which Americans can be physically active where they live, work and play, says Russell Pate, an exercise researcher at the Arnold School of Public Health at the University of South Carolina-Columbia. He chaired the panel.

Experts have been encouraging people to be physically active for years because it lowers the risk of heart disease, stroke, cancer, diabetes, osteoporosis and a long list of other health problems.

To get the health benefits of exercise, adults need at least 2½ hours of moderate-intensity activity a week, such as brisk walking, or 1¼ hours of a vigorous-intensity activity, such as jogging or swimming laps, or a combination, federal guidelines say.

But right now, only 31% of Americans do enough regular leisure-time physical activity; about 40% do no regular leisure-time physical activity, government statistics show.

Exercise tough to fit in


The national physical activity guidelines have not been sufficient to get people moving, Pate says. "Educating, cajoling and finger-wagging are not enough."

It's difficult to work physical activity into daily life, partly because of sprawling communities and long commutes, and many people don't have safe and attractive places to walk, he says.

Colleen Doyle, nutrition and physical activity director for the American Cancer Society and a member of the panel that created the plan, says, "We are at a crisis with our health in large part because we eat too much and we're not active enough."

Among ideas in the plan:


• Make sure roadway spending includes money for "complete streets," accommodating cars, bikes and pedestrians.

• Have doctors assess patients' physical activity levels at appointments and discuss ways they can meet the activity guidelines.

• Encourage early childhood education programs to have little ones as physically active as possible.

• Provide access to and opportunities for physical activity before and after school.

• Encourage school officials to find ways for children to walk and bike safely to school.

• Provide tax breaks for building owners or employers who provide amenities in workplaces that support active commuting, such as showers in buildings, secure bicycle parking, free bicycles or transit subsidies.

• Increase funding and resources for parks, recreation, fitness and sports programs and facilities in areas of high need.

Pate says such ideas would need to be implemented with cooperation from elementary school principals, county council members, state legislators, Congress and corporate human resource directors.

Price could be high

Not everyone agrees the plan will get folks moving.

"Most people are overweight not because there isn't a sidewalk in their neighborhood but because we like to eat and we don't like to exercise," says David Boaz, executive vice president of the Cato Institute, a libertarian think tank in Washington, D.C.

And the price of the changes could be high. "Everything costs something," Boaz says. "Every action has a cost, and when it's government-involved, whether it's federal or local, they are generally less efficient with money. This is the elite planning for how the masses should live."

Nancy Brown, chief executive officer for the American Heart Association and a member of the panel, says: "There's no question that anytime you want to make wholesale change on anything, there's a cost involved with it. But there is also a huge return on investment."

Some of the changes won't cost anything, Pate says. Others will require resources to be redirected, and still others will require new resources, but the payoff will come in saving lives and health care dollars, he says.

Kansas Man Leading the Charge to Change Senior Care

Morning Sun

 
Steve Shields is on a mission to change the way we take care of our parents and grandparents. Shields, an international expert on nursing homes, is president and CEO of Meadowlark Hills in Manhattan, one of the nation’s most innovative retirement communities.

“Our approach really is pretty simple. It’s to get residents involved in making their own decisions – to take control of their own lives,” Shields said.

Shields is the final speaker in this year’s Sunflower Foundation Advocacy in Health Speaker Series. He will speak at 3:30 p.m. on Wednesday, May 5, at the Oread Hotel in Lawrence. The event is free and open to the public.

Shields will emphasize the importance of nonprofits working together to help change systems of care and Raleigh retirement communitues. “In this time of increasingly scarce resources, we can’t lose our passion and our imagination for creating change,” Shields said. “Now, more than ever, we need to be strong advocates for the people we serve, and we need to help them become more effective advocates for themselves.”

“Steve was selected to present as part of our Advocacy in Health Speaker Series because of his success in changing long-held beliefs and improving lives,” said Billie Hall, president and CEO of the Sunflower Foundation.

“Sometimes ‘advocacy’ is seen as only happening through direct contact with legislators and local officials, and that’s important. But sometimes advocacy involves pushing for regulatory change – and just getting people to work together in different ways,” she said. “Steve is an excellent example of someone who helped bring about needed change by advocating within a system.”

As a pioneer in eldercare reform, Shields has helped transform traditional nursing homes and retirement facilities into the “Household” model of senior care in Michigan as well as in more than 40 other states and 10 countries. He co-authored In Pursuit of the Sunbeam: A Practical Guide to Transformation from Institution to Household and The Household Model Business Case. He is also a faculty member at the Kansas State University Center on Aging, where he teaches leadership in long term care.

This is the Sunflower Foundation’s second year to feature nationally known speakers as part of its advocacy initiative, which is designed to provide education and training opportunities for nonprofit leaders in Kansas who want to become more involved in public policy.

03 May 2010

Johnson and Johnson Recalls 43 OTC Children's Meds

The Washington Post

 
A division of Johnson & Johnson is recalling 43 over-the-counter medicines made for infants and children -- including liquid versions of Tylenol, Motrin, Zyrtec and Benadryl -- after federal regulators identified what they called deficiencies at the company's manufacturing facility.

The voluntary recall, which was announced late Friday by McNeil Consumer Healthcare, affects hundreds of thousands of bottles of medicine in homes and on store shelves throughout the United States and its territories and in nine other countries -- a vast portion of the children's medicine market.

The Food and Drug Administration is advising parents and caregivers to stop using the affected products, although Commissioner Margaret A. Hamburg called the potential for serious health problems resulting from the medications "remote."

FDA inspectors had begun a routine inspection April 19 in the company's Fort Washington, Pa., plant when they noticed "manufacturing deficiencies" that triggered the recall, said Douglas Stearn, a senior FDA official.

Stearn said the plant's manufacturing process was "not in control," a term regulators use to describe flawed procedures that affect the composition of medicine. Federal investigators do not know when the problems at McNeil began, but Stearn said that "this does go back in time" and that "we have to try to figure that out."

While the FDA investigates, McNeil has suspended operations at the facility. In a statement, the company said: "Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles." It said the problems may affect "purity, potency or quality."

Marc Boston, a McNeil spokesman, would not discuss the deficiencies cited by the FDA or say when the manufacturing facility was shut down. The company also declined to disclose the amount of products affected by the recall. In addition to the United States, Puerto Rico and Guam, the medicines were sold in Canada; the Dominican Republic; Dubai, in the United Arab Emirates; Fiji; Guatemala; Jamaica; Panama; Trinidad and Tobago; and Kuwait.

A complete list of recalled products is on the company's Web site.

McNeil received consumer complaints associated with some of the recalled medicines, but the company's decision to pull them was not made on "the basis of adverse medical events," said Boston, who declined to elaborate.

If a child who has taken any of the recalled medications exhibits any unexpected symptoms, parents or caregivers should contact a doctor, federal officials said. Consumers or health-care providers who experience problems connected to the recalled medicines are asked to contact the FDA.

As of Saturday, the FDA was not aware of any health problems related to the recalled products, said spokeswoman Elaine Gansz Bobo.

Parents and caregivers can use generic versions of the affected medicines; they are not affected by the recall. The FDA cautioned against giving adult versions to infants and children, noting the potential for serious problems.

This is at least the third major recall of Tylenol products by McNeil since 2008.


In January, McNeil recalled 49 types of Tylenol products made for adults and two Tylenol products made for children after consumers complained of a mold-like odor and of temporary and minor nausea, stomach pain, vomiting and diarrhea. The company determined that some of the medicines had been contaminated by trace amounts of a chemical that is sometimes present on shipping and storage material.

In 2008, McNeil recalled 21 types of children's and infants' Tylenol liquid products, saying that although the products met internal standards, an unused portion of one inactive ingredient did not meet all quality standards.