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FDA Announces New Safety Controls for Long-Acting Beta Agonists, Asthma Meds
Posted: 2/19/2010
The U.S. Food and Drug Administration today announced that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.
These new requirements are based on FDA analyses of clinical trials showing that use of these long-acting medicines is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults and death in some patients with asthma. The drugs involved include the single agent products Serevent and Foradil and combination medications Advair and Symbicort that also contain inhaled corticosteroids. These medications improve a patient?s ability to breathe freely and reduce the symptoms of asthma by relaxing muscles in the lung?s airways.
The FDA will now require that the product labels reflect the following:
* The use of LABAs is contraindicated without the use of an asthma controller medication such as inhaled corticosteroid. Single-agent LABAs should only be used in combination with an asthma controller medication; they should not be used alone;
* LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications;
* LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
* Pediatric and adolescent patients who require a LABA in addition to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA to ensure compliance with both medications.
"Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death," said Badrul Chowdhury, M.D., director of the Division of Pulmonary and Allergy Products in the FDA?s Center for Drug Evaluation and Research.
"The risks of hospitalization and poor outcomes are of particular concern for children; parents need to know that their child with asthma should not be on a LABA alone," said Dianne Murphy, M.D., director of the FDA?s Office of Pediatric Therapeutics.
LABAs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations only apply to the use of LABAs in the treatment of asthma.
For answers to frequently asked questions, visit http://www.lungchicago.org/news-going-in-depth/
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Cleaner air equals longer lives: study
Posted: 2/19/2010
From Reuters: BOSTON (Reuters) - Dramatic improvements in U.S. air quality over the last two decades have added 21 weeks to the life of the average American, researchers reported on Wednesday.
Reducing fine particles given off by automobiles, diesel engines, steel mills and coal-fired power plants have added as much as 15 percent of the 2.72 years of extra longevity seen in the United States since the early 1980s, they wrote in the New England Journal of Medicine.
Changes in smoking habits are the biggest reason why Americans are living longer, said Arden Pope, an epidemiologist at Brigham Young University in Utah who led the study.
Improved socioeconomic conditions, judged partly by the proportion of high school graduates living in an area, rank next. But cleaner air was a big factor.
"It's stunning that the air pollution effect seems to be as robust as it is after controlling for these other things," Pope said in a telephone interview.
Using life expectancy, economic, demographic and pollution data from 51 metropolitan areas, Pope and his colleagues found when fine-particle air pollution dropped by 10 micrograms per cubic meter, life expectancy rose by 31 weeks.
Areas such a Akron, Ohio, and Philadelphia showed that kind of drop in air pollution.
The bigger the decline, the longer people began living.
In some areas where fine-particle counts dropped by 13 to 14 micrograms -- such as Buffalo, New York and Pittsburgh -- people typically started living about 43 weeks longer.
The findings show there has been a real dividend from the efforts since the 1970s to improve air quality, said Pope.
In a commentary, Daniel Krewski of the University of Ottawa said the study "provides direct confirmation of the population health benefits of mitigating air pollution and greatly strengthens the foundation of the argument for air-quality management."
Based on earlier research, the World Health Organization has estimated that 1.4 percent of all deaths around the world are caused by air pollution particles.
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Hazards: Are Pipe and Cigar Users Blowing Smoke?
Posted: 2/15/2010
From The New York Times: Pipe and cigar smokers may say they don?t inhale, but a new study suggests otherwise.
The study, based on breathing tests in people ages 48 to 90, found that the pipe and cigar smokers had more than double the risk for abnormal lung function that contributes to chronic obstructive pulmonary disease, a leading cause of death ? even if they abstained from cigarettes. Those who also smoked cigarettes were at more than triple the risk.
Of the 3,528 subjects, all of them participants in heart disease research, 56 had smoked only pipes or cigars; 428 smoked pipes or cigars along with cigarettes; and 1,424 smoked only cigarettes.
Pipe and cigar smokers also had higher levels of the nicotine byproduct cotinine than nonsmokers, though less than what is typically found in cigarette smokers, according to the study, published in the Feb. 15 issue of Annals of Internal Medicine. The senior author, Dr. R. Graham Barr, an assistant professor of medicine and epidemiology at Columbia University Medical Center, said other studies had linked cigar and pipe smoking with heart disease, lung cancer and oral cancers. "I think it's mainly a myth that they don't inhale," he said.
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Is Railroad Emission a Dirty Little Secret?
Posted: 2/15/2010
From Chicago Public Radio: A new story in the Chicago Reporter reveals that people who live near rail yards are at a higher risk of asthma attacks and cardiac arrest. The analysis found that the exhaust emitted by locomotives and trucks contains toxic compounds like nitrogen oxide, carbon monoxide, and sulfur dioxide. Kari Lydersen wrote the story and talks more about her findings.
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Bill would require insurers to pay for anti-smoking help
Posted: 2/10/2010
From Chicago Breaking News: A bill introduced in the state Legislature today would require private health insurers to pay for stop-smoking drugs and counseling.
Under House bill 5766, insurers would be on the hook for at least $500 of annual coverage for people ages 15 years old and older. They'd be responsible for covering an array of stop-smoking approaches: counseling and support groups, over-the-counter nicotine replacement therapies, and prescription drugs.
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"Third-hand smoke" may interact with indoor air chemicals
Posted: 2/10/2010
From Bloomberg News: Tobacco smoke contamination lingering on furniture, clothes and other surfaces, dubbed thirdhand smoke, may react with indoor air chemicals to form potential cancer-causing substances, a study found.
After exposing a piece of paper to smoke, researchers found the sheet had levels of newly formed carcinogens that were 10 times higher after three hours in the presence of an indoor air chemical called nitrous acid commonly emitted by household appliances or cigarette smoke. That means people may face a risk from indoor tobacco smoke in a way that's never been recognized before, said one of the study's authors, Lara Gundel.
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EPA sets new standards for monitoring
Posted: 1/27/2010
From Post-Tribune of Northwest Indiana: Northwest Indiana asthma sufferers will have a better idea in the coming years which geographical areas to avoid for health reasons.
The U.S. Environmental Protection Agency announced Monday that it has set a new one-hour standard for nitrogen dioxide, a leading cause of smog. The new standard should ultimately reduce people's exposure to peak levels of nitrogen dioxide, especially near roads.
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Asthma sufferers choke on new smog standards
Posted: 1/26/2010
From Chicago Examiner Page One: New emissions standards are not strong enough to protect Chicagoans with asthma, a leading environmental health expert is warning.
The EPA on Monday set a new air quality standard for nitrogen dioxide (NO2) concentrations. Cook County has the highest average hourly nitrogen dioxide (NO2) concentrations measured in the United States, posing a major health threat to everyone, especially people who have lung disease.
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Chicago violates standards for smog-forming gases
Posted: 1/25/2010
From Chicago Breaking News: Chicago is the only U.S. metropolitan area that violates a tougher standard for smog-forming nitrogen oxides proposed Monday by the Obama administration.
The more stringent limit is intended to help protect people who suffer from asthma and other respiratory ailments. But Illinois officials contend they won't be able to do much about it without cleaner cars and diesel trucks, two major sources that are regulated by the federal government, not the states.
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Smokers with cancer could quit and double survival
Posted: 1/21/2010
From AP via Forbes.com: People with early lung cancer who quit smoking could double their chances of surviving, a new study says.
Until now, there has been little proof that quitting smoking after developing lung cancer makes any difference to survival.
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Rebates available on energy-efficient appliances
Posted: 1/20/2010
From Chicago Tribune: The guidelines for the Illinois Energy Star Appliance Rebate Program are now available.
Gov. Pat Quinn said Tuesday that the state of Illinois is to receive nearly $12.4 million in federal stimulus money for the program. The program provides rebates to consumers who buy qualified home appliances.
Starting Jan. 31, rebates will be available on water heaters and heating and cooling equipment. From April 16 to 25, consumers can receive a 15 percent rebate when they buy energy-efficient appliances at participating retailers. Consumers who recycle old appliances can receive an additional rebate.
Quinn says the rebate program "is a good way to help consumers be more economical and environmentally responsible."
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COPD, even when mild, limits heart function
Posted: 1/20/2010
From an NHLBI release: A common lung condition, COPD (chronic obstructive pulmonary disease) diminishes the heart's ability to pump effectively even when the disease has no or mild symptoms, according to research published in the Jan. 21 issue of the New England Journal of Medicine. The study is the first time researchers have shown strong links between heart function and mild COPD. The research was funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health.
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Current smoking can worsen lung cancer
Posted: 1/19/2010
From HealthDay News: Not only does cigarette smoke cause lung cancer, it worsens the disease by increasing lung inflammation, U.S. researchers have found.
The team at the University of California, San Diego School of Medicine conducted tests on mice with early lung cancer lesions and found that those repeatedly exposed to tobacco smoke developed larger tumors -- and developed tumors more quickly -- than those that weren't exposed to tobacco smoke. Lung tissue inflammation was the major contributing factor.
The findings, published Jan. 19 in the journal Cancer Cell, offer definitive proof that lung inflammation caused by chronic exposure to tobacco smoke promotes lung cancer growth, the researchers said.
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Adults' breathing troubles may begin in childhood
Posted: 1/15/2010
From Reuters Health: New research hints that how well your lungs function in adulthood and your risk of developing chronic breathing problems is partly determined in childhood. In a study, researchers found that early childhood "disadvantage factors" -- such as being around someone who smoked or suffering lung infections - seemed to help fuel the development of chronic obstructive pulmonary disease, or COPD, much later in life.
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Smog-limit compliance hazy for Lake, Porter
Posted: 1/8/2010
From Northwest Indiana Post-Times: EPA proposed a new range of 60 to 70 parts per billion. Based on monitoring data from 2006 to 2008, Lake and Porter counties would violate a standard of 70 parts per billion or lower. Lake County was at 77 parts per billion over those three years while Porter was at 74 parts per billion. The current standard, set by former President George Bush, is 75 parts per billion.
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