FDA Issues Warning on Key Asthma Drugs

FDA Issues Warning on Key Asthma Drugs
Advair, Foradil, Serevent and Symbicort should not be used alone due to safety concerns

By Steven Reinberg
HealthDay Reporter

THURSDAY, Feb. 18 (HealthDay News) - A new label warning will caution users of four widely used asthma drugs to avoid using these medicines as a sole or long-term means of symptom control, the U.S. Food and Drug Administration announced Thursday.

The medicines are GlaxoSmithKline's Advair and Serevent, Novartis's Foradil and AstraZeneca's Symbicort. All are in the class of drugs known as long-acting beta agonists (LABAs). Serevent and Foradil are single-agent LABAs while Advair and Symbicort also contain an inhaled corticosteroid.

LABAs should no longer be used alone in treating adults and children, the FDA said. In making its decision, the agency cited studies that found that using the drugs alone can actually increase the severity of asthma, leading to hospitalizations and even death.

The drugs should only be used for the shortest time possible, until asthma symptoms are under control, and be "discontinued, if possible, once asthma control is achieved," the agency said in a statement. People should then switch to another medication to maintain symptom control, the FDA said.

"We think the overall public health benefit is to reduce the use of LABAs," Dr. John Jenkins, director of FDA's Office of New Drugs in the Center for Drug Evaluation and Research, said during an early afternoon press conference Thursday.

"As we weighed the risks against the benefit of the drug, we recognized that there is still benefit for these products in patients who aren't adequately controlled on asthma controller medications," Jenkins said. "We wanted to maintain availability of these products, while also encouraging the safe use of the product."

According to Jenkins, most people should only require an inhaled corticosteroid to control their symptoms.

LABAs work to improve breathing and reduce asthma symptoms by relaxing the lung's airway muscles.

One expert said the announcements don't signal a radical departure for asthma care, although the recommendation to stop LABA use as soon as possible could bring problems for some.

"This could complicate care in certain settings," said Dr. Norman Edelman, chief medical officer for the American Lung Association. "This will require careful tailoring of treatment to individuals' disease and circumstance. Physicians should be aware of new guidelines and do so."

The makers of the four drugs will have to add this information to their product labels:

• These drugs must be used along with other asthma medications such as an inhaled corticosteroid.
• The drugs should only be used in people whose asthma is not controlled by other drugs.
• They should be used for the shortest time possible to bring asthma under control, and then other asthma drugs should replace them.
• Children and adolescents who need these drugs should use only combination drugs that contain both a LABA and a corticosteroid.

Although the drugs are also approved for use in chronic obstructive pulmonary disease (COPD), this warning only applies to their use by asthma patients, the agency said.

In addition, the FDA is requiring that manufacturers of these drugs do more studies to determine the safety of the medications when combined with inhaled corticosteroids.

One industry representative said her company supported the FDA move.

"AstraZeneca supports the efforts of the FDA to share additional benefit/risk information within the product label and will work closely with the FDA to make the appropriate changes," said company spokeswoman Dana Settembrino. "AstraZeneca is confident in the positive benefit-risk profile of Symbicort, which has been demonstrated by extensive clinical trial data and through use by millions of patients worldwide."

Thursday's announcement follows an FDA advisory panel decision in December 2008. The panel found that the risks linked to single-agent Serevent and Foradil outweighed their benefits for children and adults. At the time, Advair and Symbicort were excluded from that decision.

More information

For more information on asthma, visit the U.S. National Institutes of Health.

SOURCES: Feb. 18, 2010, teleconference with: John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Norman Edelman, M.D., chief medical officer, American Lung Association; Dana Settembrino, spokeswoman, AstraZeneca

Last Updated: Feb. 18, 2010

Remove Diabetes Drug Avandia From Market

Remove Diabetes Drug Avandia From Market: FDA Documents
Controversial medicine raises users' heart risk, leaked files suggest

By E.J. Mundell

SATURDAY, Feb. 20 (HealthDay News) -- The blockbuster type 2 diabetes drug Avandia raises users' odds for heart attack and heart failure and should be removed from the market, according to confidential U.S. government reports.

The New York Times on Saturday reported on documents from the U.S. Food and Drug Administration that find that if people now taking Avandia (rosiglitazone) switched to a similar medication, Actos, about 500 heart attacks and 300 cases of heart failure would be eliminated each month. And in a report from the Institute for Safe Medication Practice, Avandia was linked to 304 deaths in the third quarter of 2009 alone, the highest for any prescribed drug in that time period, the Times reported.

In one of the FDA documents, dated October 2008, Drs. David Graham and Kate Gelperin -- drug safety officials at the agency -- agreed that "rosiglitazone should be removed from the market."

The reports, obtained early by the Times, are yet another chapter in Avandia's checkered history. The drug was once taken by millions worldwide, but that changed after a study released in early May of 2007 by the Cleveland Clinic suggested that Avandia carried cardiovascular risks. That study, which included more than 28,000 people, found that Avandia increased a user's odds of heart attack by 43 percent compared to those not taking the medicine.

At the time, Dr. Bruce M. Psaty of the University of Washington -- who also co-wrote an accompanying editorial in the New England Journal of Medicine -- urged the FDA to restrict access to Avandia and cited both the agency and the drug's maker, GlaxoSmithKline, for poor oversight.

"The primary problem here is that studies that were needed early on about the health benefits of this drug were never done," Psaty told HealthDay. "As a result of the failure of the sponsor to do long-term clinical trials to show health benefits, as a result of the failure of the FDA to insist on it, we have data that are weak."

Following on the Cleveland Clinic study, the FDA demanded "black box" warnings on labeling for both Avandia and Actos, warning of a potentially heightened risk for heart failure. However, other studies found no raised level of heart risk, and at the time the agency said it had not reached a definitive conclusion on the data.

In November of the same year, the FDA updated Avandia's labeling to include a caution regarding heart attack risk. At the time, Dr. Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research, said that, "we are keeping Avandia on the market because we have concluded there isn't enough evidence to indicate that the risk of heart attack is higher for Avandia than other type 2 diabetes treatments."

The story got more complicated in 2008, as a number of studies emerged tying the use of Avandia to increased bone fracture risk.

Throughout 2009, more studies reiterating the drug's heart risks also came to light, including one published in the BMJ suggesting that Avandia's risk for heart failure seemed to outstrip those of its related rival, Actos.

By that point, "most clinicians [had] stopped using Avandia -- some will use Actos instead or go to another class completely," Dr. Carl J. Lavie, medical director of cardiac rehabilitation at the Ochsner Heart and Vascular Institute in New Orleans, told HealthDay at the time.

The emergence of the leaked documents on Saturday comes at a time when officials within the FDA seem to be at loggerheads over whether to ban Avandia or not, the Times reported. The newspaper said that some officials believe that safer alternatives exist, while others say the evidence on Avandia's safety is conflicted and the drug should remain available as a treatment option.

Trying to sort things out, in December of 2009 Woodcock asked officials at the FDA to convene another advisory committee to determine whether Avandia should remain on the market, with a decision expected this summer.

In the meantime, a bipartisan Senate investigation -- overseen by Sen. Max Baucus (D-Mont.) and Sen. Charles E. Grassley(R-Iowa) -- has pored over 250,00 internal documents from GlaxoSmithKline. The investigation has placed much of the blame for the Avandia debacle on the company, contending that it neglected to warn patients for years of the drug's dangers.

"G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk," according to the Senate investigation report, which is slated for release Monday but was obtained early by the Times.

Speaking to the newspaper Friday night, agency commissioner Dr. Margaret Hamburg said that, "I await the recommendations of the advisory committee. Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved."

In a statement released Saturday, GlaxoSmithKline said it "rejects the conclusions about the safety of Avandia (rosiglitazone)" as reported in that day's Times story.

"Contrary to the assertions in the story, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk or causes myocardial ischemic events," the company said. "In 2007, the FDA considered all the available scientific evidence on Avandia, including Dr. Graham's assertions of elevated heart attack risk and demands that the product be withdrawn. Based on the scientific evidence and a recommendation by an independent advisory committee of experts convened by the FDA, the agency has ruled that Avandia remain available to patients for the treatment of Type 2 diabetes."

In the wake of the controversy, GlaxoSmithKline had been directed by the FDA to conduct a trial comparing rates of heart attacks, strokes and heart-linked deaths among users of Avandia, Actos or a placebo. But according to internal documents accessed by the Times, Graham and Gelperin characterized the study, called TIDE, as "unethical and exploitive," with patients being given Avandia despite the fact that it appears to come with greater risks and no added benefit over Actos.

One of the Graham/Gelperin reports -- dated October 2008 -- concludes that, "Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable."

However, other FDA officials overruled those concerns and TIDE is still enrolling patients, with preliminary results expected by 2014. Responding to the criticism, GlaxoSmithKline noted Saturday that, "TIDE has been approved by an independent review board and appropriate safety boards that are responsible for assessing the safety of conducting the trial."

The ongoing controversy has dampened patients' and physicians' enthusiasm for Avandia. According to the Times, while sales of the drug topped $3.2 billion in 2006, those numbers plummeted soon after the first studies suggesting risk emerged a year later.

Still, "hundreds of thousands" of people still take Avandia, the Times noted. GlaxoSmithKline's patent on the drug expires in 2012.

More information

Find out more about diabetes care at the American Diabetes Association.

SOURCES; Carl J. Lavie, M.D., medical director, cardiac rehabilitation, and prevention director, Stress Testing Laboratory, Ochsner Heart and Vascular Institute, New Orleans; Bruce M. Psaty, M.D. Ph.D., University of Washington, Seattle; Feb. 20, 2010, news release, GlaxoSmithKline; Feb 20, 2010, The New York Times

Last Updated: Feb. 21, 2010

Shot Protects Against Chickenpox After Exposure

Shot Protects Against Chickenpox After Exposure
Vaccination within 5 days prevents or lessens illness in those at risk, study finds

TUESDAY, Jan. 26 (HealthDay News) -- There is good news for people who have never had chickenpox or received the vaccine but are exposed to the virus: vaccination within five days of exposure can significantly reduce the risk of illness, or at least make it less severe, Spanish researchers say.

The study, published in the January issue of the Pediatric Infectious Disease Journal, found that out of 67 people who received the varicella zoster vaccine within five days of exposure to chickenpox, only 22 got sick. That's about 62 percent fewer than would be expected to become ill with the disease. Based on past studies, 58 out of the 67 would be estimated to develop chickenpox.

The patients who did get chickenpox developed mild to moderate cases, suggesting that the vaccine is 79 percent effective in preventing moderate to severe disease. It didn't matter if those vaccinated were children or adults: the vaccine appeared to have the same effectiveness, the study authors noted in a news release from the journal's publisher.

"Available varicella vaccines administered within five days after exposure to chickenpox are effective in preventing chickenpox and highly effective in attenuating the disease," Dr. Maria Brotons and colleagues of Hospital Universitario Vall d'Hebron, Barcelona, stated in the news release.

Chickenpox often causes mild illness, but the virus can cause complications and scarring. Young children and teens are especially at risk of developing rare complications that can be serious.

More information

The Nemours Foundation has more on chickenpox.

-- Randy Dotinga

SOURCE: Lippincott Williams & Wilkins, news release, January 2010

Last Updated: Jan. 26, 2010

With Autism, Diet Restrictions May Do More Harm Than Good

With Autism, Diet Restrictions May Do More Harm Than Good
Study finds no increase in gastrointestinal problems in kids with the disorder

By Amanda Gardner
HealthDay Reporter

MONDAY, July 27 (HealthDay News) -- Children with autism do not have a higher incidence of gastrointestinal problems than other children, a new study has found.

However, autistic children do have a higher rate of constipation and eating issues, such as eating the same foods over and over, according to the study. But any number of factors, including medication, could cause these issues, the researchers said.

The findings appear in the August issue of Pediatrics.

Dr. Patricia Manning-Courtney, medical director of the Kelly O'Leary Center for Autism Spectrum Disorders at Cincinnati Children's Hospital Medical Center, said that the study is an important one because it was the first to scientifically compare the incidence of gastrointestinal (GI) problems in an autistic population with incidence in children who are developing normally.

Even so, it's unlikely to quell a controversy that has been raging for more than a decade.

"A couple of highly publicized cases of autism and loose stools in the late 1990s led to an impression that children with autism had a higher rate of GI dysfunction," she said. "It wasn't well characterized, but that got the story onto the national scene."

This, in turn, led to theories that diets free of gluten and the milk protein casein might help the problems, along with treatment with the hormone secretin. Some even proposed that problems with the gut might be the cause of autistic symptoms, giving the matter added urgency.

But the evidence in favor of these hypotheses was "fuzzy," Manning-Courtney said.

For the new study, researchers followed 124 children with autism and 248 children without autism until they turned 18.

Gastrointestinal diagnoses were classified into five groups: constipation; diarrhea; abdominal bloating, discomfort or irritability; gastroesophageal reflux or vomiting; and feeding issues or selectivity (people with autism often stick with the same food choices and have other "ritualistic tendencies" in eating).

The frequency of GI symptoms was about 77 percent in the autism group and 72 percent among the others, not considered a statistically significant difference.

However, almost 34 percent of the autistic children, compared with nearly 18 percent of the others, had constipation. Feeding issues were present in about 24 percent of the autistic children and 16 percent of those who weren't autistic, the study authors found.

Those differences could stem from what the researchers called neurobehavioral issues connected with autism, such as the ritualistic practices, they said.

"Many patients with autism insist on eating the same thing and might not consume enough fiber," said the study's lead author, Dr. Samar H. Ibrahim, a fellow in gastroenterology and instructor in pediatrics at the Mayo Clinic. "We think this may be contributing to the constipation."

Medications that autistic children take can also interfere with appetite and eating.

"In our study, around 50 percent of children were on stimulant medications, and those might affect appetite and might have something to do with issues with food," Ibrahim said.

Keith A. Young, vice chairman for research in the psychiatry and behavioral science department at Texas A&M Health Science Center College of Medicine, said he thought "the really interesting thing they found was that there wasn't any indication of celiac disease."

In the group studied, the researchers found just one case. A possible link between celiac disease and autism was proposed as far back as 1961.

"The only difference [between the two groups] was the constipation, which they kind of dismiss," Young said. "And I tend to agree with their conclusion that constipation might be related to the dietary habits of autistic kids."

The constipation and feeding difficulties identified in the study, though, are not the symptoms that people have been buzzing about, Manning-Courtney pointed out. It's mostly been about diarrhea and loose stools.

But the study was a small one and did not rely on rigorous, comprehensive diagnoses of autism for the participants, so it may just stir the pot for people on both sides of the debate.

The researchers, however, are urging parents away from restrictive diets.

"Patients with autism should be investigated the same way as normal patients when they have GI symptoms," Ibrahim said. "And doctors should do a thorough investigation before labeling them with any GI disorder because the overall incidence of any GI disorder did not differ from that of the overall population."

Manning-Courtney concurred. "For me, this study lends support to the recommendation I make to a lot of families that there is no evidence to support restricted diets," she said. "They're dangerous and risky. You have to think long and hard before you, as a parent, make that choice."

More information

Autism Speaks has more on autism.

SOURCES: Samar H. Ibrahim, M.B.Ch.B., fellow, gastroenterology, and instructor, pediatrics, Mayo Clinic, Rochester, Minn.; Patricia Manning-Courtney, M.D., medical director, Kelly O'Leary Center for Autism Spectrum Disorders, Cincinnati Children's Hospital Medical Center, Cincinnati; Keith A. Young, Ph.D., vice chairman, research, Department of Psychiatry and Behavioral Science, Texas A&M Health Science Center College of Medicine, College Station, Texas, and chairman, Tissue Advisory Board, Autism Speaks; August 2009 Pediatrics

Last Updated: July 27, 2009

Rotavirus Vaccine Could Save Millions of Children Worldwide

Rotavirus Vaccine Could Save Millions of Children Worldwide
Trials in Africa, Mexico show shot protects from the common diarrhea-causing disease

By Jennifer Thomas

HealthDay Reporter

WEDNESDAY, Jan. 27 (HealthDay News) -- Vaccinating infants ag

ainst rotavirus could save the lives of millions of children in developing nations who would otherwise die from the diarrhea-causing disease, two new studies show.

A study conducted in Malawi and South Africa found vaccinations reduced the rate of severe, life-threatening rotavirus in infants by more than 61 percent.

A second study found deaths from diarrheal disease in Mexico fell by more than 66 percent in children 11 months and younger during the 2009 rotavirus season compared to 2003-2006. In 2006-2007, Mexico's Ministry of Health and other major health providers made the rotavirus vaccine part of its national vaccination programs.

"A disease that may be a nuisance in the U.S. can be a killer in a poorer country," said Dr. Kathleen Neuzil, senior author of the African study and a senior advisor for immunization at PATH, an international non-profit organization that seeks to bring affordable health care to all. "Death from diarrheal disease in general is the second-leading cause of death among kids in developing nations."

The studies are published in the Jan. 28 issue of the New England Journal of Medicine.

More than half a million children die each year from rotavirus infection, according to the World Health Organization (WHO). Nearly half of those deaths occur in sub-Saharan Africa. Though there are many gastrointestinal diseases that can cause life-threatening diarrhea, rotavirus is among the most common. Among children hospitalized for severe diarrhea, rotavirus is the culprit in about 40 percent of cases globally, according to background information in the study.

Rotavirus is also common in the United States, with most children having a bout of it before 3 years of age, Neuzil said. But few American children die, largely because of better access to medical care and treatments such as oral rehydration -- a mixture of water and electrolytes.

The U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommends that American children receive the rotavirus vaccine at 2, 4 and 6 months of age.

But before the WHO's Strategic Advisory Group of Experts on Immunization would recommend vaccinating children in developing nations, it wanted to see research that showed the vaccines would be effective in poorer nations, Neuzil said.

Both of the rotavirus vaccines available are live oral vaccine. Prior research on other live oral vaccines, including polio and cholera, has shown they don't work as well among very low-income populations. The reasons are unclear, but some suspect poorer nutrition or higher rates of the disease in those countries mean that children may already have some antibodies to the virus, perhaps through breast milk, so the vaccine may not fully "take," Neuzil said.

Prior to publication of the new studies, the results were shared with WHO, which has since recommended the rotavirus vaccine for infants in developing nations, with the first dose being given between 6 and 15 weeks of age.

The WHO's recommendation is critical, Neuzil said, not only for influencing health-policy decisions, but for starting the flow of aid and philanthropic dollars to pay for rotavirus vaccination programs.

In the study in Africa, researchers divided nearly 5,000 infants from Malawi and South Africa into three groups: one-third received three doses of the vaccine, one-third received two doses and one-third received a placebo. Researchers then followed-up with weekly home visits and took stool samples to confirm suspected rotavirus infections.

Children who had received either the three-dose or the two-dose regimen were 61 percent less likely to develop severe rotavirus infection. In Malawi, the effectiveness was 49 percent, compared to about 77 percent in South Africa.

In the study in Mexico, the effect was no less dramatic. During the 2009 rotavirus season, deaths among infants 11 months old and younger fell 66 percent.

In 2003-2006, about 1,793 children under age 5 died from diarrhea-related diseases each year in Mexico. In 2008, that dropped to 1,118, or nearly a 35 percent reduction. Among children between ages 1 and 2 years, deaths fell by about 29 percent in 2008, even though only 10 percent to 15 percent of the population was eligible for vaccination.

In an accompanying editorial, Dr. Mathuram Santosham, a professor of international health and pediatrics at Johns Hopkins University Bloomberg School of Public Health, said the studies provide powerful evidence for instituting rotavirus vaccination programs in developing nations throughout the world.

Malawi, South Africa and Mexico are countries with very different socio-economic patterns, Santosham said, with Malawi among the poorest in the world and South Africa relatively more affluent.

"The data from Mexico is representative of data that one would expect from Latin American countries," he said. "Therefore, I believe that these data can be extrapolated to the majority of developing countries."

Still, there are challenges. To protect children, WHO recommends infants receive the first dose between 6 and 15 weeks. In poorer nations, adherence to those guidelines can be spotty.

"Rotavirus vaccine is a very powerful tool to combat one of the leading causes of childhood deaths -- diarrhea," Santosham said. "The challenge now is to make sure that every poor child in the world has access to this life-saving intervention."

In a related study from the same journal, researchers cautioned that vaccinating immune-compromised children may make them sick. But the illness is likely to be mild even in children who are HIV-positive, Santosham said in his editorial.

More information

The World Health Organization has more on rotavirus vaccine.

SOURCES: Kathleen Neuzil, M.D., M.P.H., senior advisor for immunization, PATH, Seattle; Mathuram Santosham, M.D., M.P.H., professor, international health and pediatrics, Johns Hopkins University Bloomberg School of Public Health, Baltimore; Jan. 28, 2010, New England Journal of Medicine

Last Updated: Jan. 27, 2010

Raising Co-Pays for Doctor Visits Raises Seniors' Hospital Use

Raising Co-Pays for Doctor Visits Raises Seniors' Hospital Use
Study suggests higher cost-sharing for outpatient visits may increase overall spending

By Karen Pallarito
HealthDay Reporter

WEDNESDAY, Jan. 27 (HealthDay News) -- Boosting co-pays for doctor visits and other outpatient care reduces seniors' use of those services, but it also may have the unintended consequence of sharply increasing hospitalizations, a new study suggests.

That money-saving strategy could end up inflating overall health-care spending and put vulnerable elderly at risk of skimping on needed care, the study authors suggest in a paper published in the Jan. 28 issue of the New England Journal of Medicine.

"From our perspective, it looks like increasing ambulatory-care co-payments for elderly patients is a counterproductive cost-containment strategy," said study author Dr. Amal N. Trivedi, an assistant professor of community health at the Alpert Medical School of Brown University in Providence, R.I. "It's a lose-lose proposition for most health plans because our study suggests it results in more health-care spending, and it's likely to harm the health of enrollees."

The study, involving nearly 900,000 seniors in 36 Medicare managed-care plans, is one of the first large, national examinations of the consequences of raising seniors' co-payments for outpatient services, the authors said.

The new findings are consistent with research on cost-sharing for prescription drugs, which shows that failing to consider the value of the medication or a person's medical and economic status can harm health, the research team noted.

Marsha Gold, a senior fellow at Mathematica Policy Research Inc. in Washington, D.C., said the effect on inpatient care shown in the study "seems a little high." But she agreed that appropriate use of health-care services is always a concern as cost-sharing goes up.

"When you're putting cost-sharing requirements on patients, you need to be aware of the different kinds of effects that it can have, both positive and negative," she said.

From a sample of 172 Medicare managed-care plans, Trivedi and colleagues identified 18 plans that raised outpatient co-payments between December 2001 and January 2006. Eighteen plans that made no changes in co-payments served as controls.

In Medicare plans that raised co-payments, the average amount seniors had to shell out nearly doubled, to $14.38 from $7.38 for primary care and to $22.05 from $12.66 for specialty care. In control plans, the average co-payment for primary and specialty care held steady at $8.33 and $11.38, respectively.

Medicare managed-care plans that increased co-payments had 19.8 fewer annual outpatient visits per 100 enrollees in the year after the increase, compared with plans that made no changes.

However, plans that hiked co-payments also had 2.2 additional annual hospital admissions and 13.4 more annual inpatient days per 100 enrollees, and the percentage of hospitalized enrolled increased by 0.7 percentage points.

Use of inpatient care was even greater for low-income and little-educated enrollees, blacks and seniors with hypertension, diabetes or a history of heart attack.

Trivedi said the concern is that people with these medical conditions may not be properly managed if higher co-payments are discouraging them from obtaining treatment in the outpatient setting.

"Our study suggests that health plans should refrain from increasing co-payments among the elderly and perhaps give some serious thought to reducing them, particularly for enrollees with chronic disease and low income," he said.

The authors estimate that a Medicare plan might save $7,150 per 100 enrollees in the short-term by boosting outpatient co-payments, but inpatient spending would swell by $24,000 per 100 enrollees in the year after the co-payment increase.

Gold urges seniors to get help understanding the various Medicare options available to them and weighing their total financial risk, including the premium and out-of-pocket cost-sharing. "It's worth stepping back and looking at the big picture," she said.

More information

Learn more about Medicare's health plan options at Medicare.gov.

SOURCES: Amal N. Trivedi, M.D., M.P.H., assistant professor, community health, Alpert Medical School, Brown University, Providence, R.I.; Marsha Gold, Sc.D., senior fellow, Mathematica Policy Research Inc., Washington, D.C.; Jan. 28, 2010, New England Journal of Medicine

Last Updated: Jan. 27, 2010

Wooden Toilet Seats Can Trigger Children's Rash

Wooden Toilet Seats Can Trigger Children's Rash
Harsh disinfectants can also prompt seat-linked skin woes, experts warn

MONDAY, Jan. 25 (HealthDay News) -- Harsh cleaning chemicals and wooden toilet seats -- especially those with varnishes and paints -- may be among the reasons why U.S. cases of toilet seat-related skin irritations among children appear to be increasing, researchers say.

Children can develop toilet seat dermatitis after repeated exposure to residue from harsh cleaning chemicals or after several uses of a wooden seat, said Dr. Bernard Cohen, director of pediatric dermatology at Johns Hopkins Children's Center, and colleagues.

The researchers analyzed five cases of toilet seat dermatitis among children in India and the United States, and report their findings in the February issue of the journal Pediatrics.

"Toilet seat dermatitis is one of those legendary conditions described in medical textbooks and seen in underdeveloped countries, but one that younger pediatricians have not come across in their daily practice," Cohen said in a Johns Hopkins news release. "If our small analysis is any indication of what's happening, we need to make sure the condition is on every pediatrician's radar."

The study found that missed and delayed diagnoses occurred in every case before a doctor made the correct diagnosis.

Any time a pediatrician sees a child with skin irritation around the buttocks or upper thighs, they should ask about toilet seats and cleansers used at home and at school, Cohen said.

Most cases of toilet seat dermatitis are mild and easy to treat with topical steroids. However, if not treated properly, the inflammation can persist and spread, causing painful and itchy skin eruptions and unnecessary discomfort for children and parents. Skin that's persistently irritated is vulnerable to bacteria and may lead to more serious infections that require treatment with oral antibiotics.

Cohen and his colleagues offered tips on how to prevent toilet seat dermatitis:

• Use paper toilet seat covers in public restrooms.
• Replace wooden toilet seats with plastic ones.
• Clean toilet seats and bowls daily.
• Don't use harsh cleansers, which often contain skin-irritating chemicals. Instead, use rubbing alcohol and hydrogen peroxide, which is effective and gentler on the skin.

More information

The U.S. National Library of Medicine has more about contact dermatitis.

-- Robert Preidt

SOURCE: Johns Hopkins Children's Center, news release, Jan. 25, 2010

Last Updated: Jan. 25, 2010

Copyright © 2010 HealthDay. All rights reserved.