Yourlawyer.com (Asthma News)

AstraZeneca Experiences Approval Delays with Symbicort for Children

Mon, 06 Apr 2009 00:00:00 -0400

The release of asthma drug, Symbicort, is being delayed for approval to young children. Reuters said that regulators have asked Symbicort maker, AstraZeneca Plc, for additional information before it can consider allowing expansion of the drug’s use. Symbicort is an inhaled combination medication that contains a corticosteroid and a long-acting beta-agonist and is used to treat asthma as well as chronic obstructive pulmonary disease (COPD) in adults.

Symbicort is approved for patients aged 12 and over, but AstraZeneca is hoping for approval for “long-term maintenance treatment of asthma in” children ages six to 11 said Reuters. The Food and Drug Administration (FDA) said the drug maker has not yet given sufficient information to determine an appropriate dose or doses of the drug's two medications—budesonide and formoterol—in the younger pediatric group, reported Reuters. Because of this, the FDA is seeking additional information before issuing approval.

"We had expected Symbicort to increase market share after approval in children (currently 10 percent of U.S. prescriptions) and thus the delay could impact growth of the product going forward," WestLB analyst Simon Mather said in a research note, quoted Reuters. The FDA issued a Complete Response Letter (CRL), which stated that the agency is not ready to approve the medication, said Reuters. The drug maker, in a statement today, said it “is evaluating the CRL and will provide a response to the agency in due course,” quoted Reuters.

Symbicort was approved in 2006 and its primary competitor is GlaxoSmithKline’s Advair, said the Wall Street Journal (WSJ), which has already been approved for pediatric patients as young as young as age four, said Reuters. The delay is seen as a big setback to AstraZeneca.

The Journal pointed out that, according to Navid Malik, a Matrix Corporate Capital analyst, the delay “won’t help” AstraZeneca’s public image following concern expressed by the FDA over broadening its use of Seroquel, its antipsychotic medication.

We recently reported that Advair, Symbicort, and other inhaled corticosteroids might increase the risk of pneumonia in patients with COPD by as much as 70 percent, according to a news study. The study, conducted by researchers at Wake Forest University Baptist Medical Center, was published in the Archives of Internal Medicine.
Advair and Symbicort are both known as long-acting beta-agonists (LABAs), a class of drugs used to treat asthma; both medications use a LABA with an inhaled steroid. Other LABAs, such as Serevent and Foradil, do not contain a steroid. Those taking a corticosteroid, either alone or with a LABA, increased their risk of developing pneumonia by 60 to 70 percent, which means that about one in every 47 people with COPD who uses a corticosteroid inhaler for a year is likely to develop pneumonia.

In December, we reported that one expert estimated that LABAs such as Symbicort, Severent, Foradil, and Advair might be responsible for about 14,000 deaths, according to an earlier Reuters report. The comments were part of a confrontational meeting between the FDA and an advisory panel discussing how to handle increased risks experienced with the inhaled asthma medications, said Reuters.

Study Confirms Second Hand Smoke Worse for Children

Wed, 22 Oct 2008 00:00:00 -0400

In a study to be presented at the annual American Society of Anesthesiologists that concludes today in Orlando, Florida, researchers will discuss how children exposed to secondhand smoke often have levels of carbon monoxide in their blood similar to those of adult smokers. Worse, children frequently test with higher levels than adults exposed to secondhand smoke and the younger the child, the greater the potential for exposure. The physiology of children—especially the youngest—is different from that of adults," said Dr. Branden E. Yee, of the anesthesiology department at Tufts Medical Center in Boston, on behalf of the society. "Children breathe in a greater amount of air per body weight compared to adults."

The study measured carboxyhemoglobin levels in 200 children between the ages of one and 12. Carboxyhemoglobin is formed when carbon monoxide binds to the blood. While complete effects of high levels of carboxyhemoglobin are not entirely known, it is known that long-term, low-level exposure causes changes in heart and lung tissue, impeding distribution of oxygen to body tissue. Also, while household and environmental factors—stoves, heaters, and automobiles—are some of the sources of carbon monoxide exposure, secondhand cigarette smoke is typically the likeliest source of elevated carboxyhemoglobin, the researchers said.

Yee said educating parents about the need to change their smoking habits, especially around children, is vital. "Personalized education coupled with the act of physically showing a parent the carboxyhemoglobin measurement in his or her child's blood may provide a graphic and concrete message to that parent," he added.

In recent years, secondhand smoke has emerged as a public health threat, being classified as a carcinogen by the Environmental Protection Agency (EPA) and linked to heart disease, lung cancer, and a number of respiratory ailments, including asthma and chronic bronchitis. Children are particularly susceptible to the harmful effects of secondhand smoke. According to the American Lung Association, 35 percent of American children live in homes where regular smoking occurs.

Experts have long known that exposure to secondhand smoke either prenatally or early in life can raise a child's risk of developing asthma symptoms, allergies, and respiratory symptoms in children. Second hand smoke has also been found to slows lung growth in children and also causes sudden infant death syndrome (SIDS), acute respiratory infections, ear problems, and more frequent and severe asthma attacks in children.

There is no risk-free level of secondhand smoke exposure. Even brief exposure can be dangerous. Secondhand smoke, also known as environmental tobacco smoke, is a complex mixture of gases and particles that include smoke from the burning cigarette, cigar, or pipe tip as well as exhaled smoke and contains at least 250 chemicals known to be toxic, including over 50 that can cause cancer. Exposure causes heart disease and lung cancer in nonsmoking adults; nonsmokers exposed to secondhand smoke increase their heart disease risk by 25–30% and their lung cancer risk by 20–30%. Those with heart disease are at especially high risk.

Pesticide Exposure Linked to Asthma in Farm Workers

Thu, 03 Jan 2008 00:00:00 -0500

Pesticides could be putting some farm workers at a higher risk of developing asthma. Women who work on farms and who use pesticides are more likely than nonpesticide users to develop allergic asthma as adults, a U.S. study shows. Asthma is a chronic inflammation of the bronchial tubes, or airways, causing airway constriction and resulting in breathing difficulties. The bronchial narrowing is usually either totally or at least partially reversible with treatments. Chronically inflamed bronchial tubes may become overly sensitive to allergens (specific triggers) or irritants (nonspecific triggers). The airways may become twitchy, remaining in a state of heightened sensitivity called "Bronchial Hyper-Reactivity" (BHR). It is likely that there is a spectrum of bronchial hyper-reactivity in all individuals; however, it is clear that asthmatics have a greater degree of bronchial hyper-reactivity than nonasthmatic and nonallergic people. In sensitive individuals, bronchial tubes are more likely to swell and constrict when exposed to triggers such as allergens, tobacco smoke, or exercise. Among asthmatics, some may have mild BHR and no symptoms while others may have severe BHR and chronic symptoms.

This effect is particularly strong for the 60% of farm women who grew up on a farm. People who grow up on farms have a reduced risk of allergies. Pesticide users have less of this protection, find Jane A. Hoppin, ScD, of the National Institute of Environmental Health Sciences, and colleagues. "Growing up on a farm is such a huge protective effect it's pretty hard to overwhelm it," Hoppin said in a news release. "There is a difference in asthma prevalence between women who did and did not use pesticides, but whether it is causal or not remains to be seen."

Hoppin's team collected self-reported data from 25,814 farm women from Iowa and North Carolina. This data included detailed information on pesticide use and whether, as adults, they had doctor-diagnosed allergic or nonallergic asthma. Farm women who grew up on farms were about half as likely to have allergic asthma—and about 20% less likely to have nonallergic asthma—as were women who were not farm children. Yet, pesticide use was most strongly linked to allergic asthma in farm-raised women. "It is likely that the association with pesticides is masked in the general population due to a higher baseline rate of asthma," Hoppin suggests. Use of any pesticide on the farm upped a woman's risk of allergic asthma by 46%, but did not increase risk of nonallergic asthma. Even so, the risk was not large. Only 181 of 14,767 pesticide users reported allergic asthma. Ten of 31 analyzed pesticides were linked to allergic asthma, including two herbicides (2,4-D and glyphosate), seven insecticides (carbaryl, coumaphos,
DDT, malathion, parathion, permethrin on animals, and phorate), and one fungicide (metalaxyl). "Pesticides, particularly organophosphate insecticides, may increase asthma risk," Hoppin and colleagues conclude.

Just because there is a link between pesticides and allergic asthma doesn't necessarily mean pesticides cause asthma. Hoppin says that in 2008, her team is hoping to start a new study to better evaluate this link. Their current report appears in the January 1st issue of the American Journal of Respiratory and Critical Care.

Post-Traumatic Stress Disorder, Asthma Linked

Thu, 29 Nov 2007 00:00:00 -0500

Post-Traumatic Stress Disorder (PTSD) is associated with an elevated prevalence of asthma, says a new study in The American Journal of Respiratory and Critical Care Medicine. The link between PTSD and asthma existed even after adjusting for factors such as cigarette smoking, obesity, and socioeconomic placement. Researchers state that efforts to understand this co-morbidity may help in identifying modifiable environmental risk factors and in developing more effective prevention and intervention protocols for the future.

The study involved 3,065 male twin pairs-both identical and fraternal-who lived together in childhood and had both served on active military duty during the Vietnam War. Both identical and fraternal twins were included, with similar findings, so genetic influences for the results were ruled out. Also, factors such as cigarette smoking, obesity and socioeconomic status had no appreciable effect on the findings

While the new study suggests there is a link between asthma and PTSD, experts do not fully understand why or whether asthma increases the risk that someone who experiences a traumatic event will have PTSD or if people who have PTSD are just at greater risk for asthma. Similar links have been previously noted between asthma and anxiety and asthma and depression, further confirming that there is an association between asthma and mental disorders. Previous studies indicated a more general link between anxiety disorders and asthma, but this study focused specifically on PTSD. The study also confirmed that those who suffered the most from PTSD were more than twice as likely to have asthma. Researchers are not sure what mechanisms are behind the association and there is speculation that a traumatic stressor could trigger both PTSD and asthma. Perhaps one condition could contribute to the other; perhaps this is a cause-and-effect relationship.

The findings suggest that a person with asthma who experiences a traumatic event may benefit from seeking professional help because they could be at increased risk of developing PTSD. The link between PTSD and asthma does not appear to be primarily due to a common genetic predisposition. Had there been a strong genetic component to the link, the results between the two types of twins would have been different.

Suffering a trauma such as the September 11th terror attacks, assault, or war can be extremely stressful for weeks, months, and even years afterwards. Survivors may have trouble coping with everyday life and/or suffering with nightmares, flashbacks, intrusive memories, exaggerated emotional and physical reactions, panic attacks that are linked to triggering events. Re-experiencing the trauma through these reactions reminds the survivor of the trauma and can lead to sleeplessness, depression, substance abuse, eating disorders, emotional numbing, hyper-vigilance; an array of worrisome or dangerous responses. Surviving PTSD often requires a committed and long-term combination of time, therapy, and medication.

PTSD is a medically recognized disorder that occurs in normal individuals under extremely stressful conditions. Symptoms affect people from all walks of life, including soldiers, victims of natural disasters, or serious accidents and can affect people who provide emergency services for others, such as the emergency workers deployed to Ground Zero following the September 11th terrorist attacks.

Researchers Say "Killer" Asthma Inhalers Should Be Recalled

Tue, 20 Jun 2006 00:00:00 -0400

Researchers from Cornell and Stanford universities have concluded three common asthma inhalers containing the drugs salmeterol or formoterol may be causing four out of five U.S. asthma-related deaths per year and should be taken off the market.

The researchers made their recommendation after concluding a search of medical literature.

They base these conclusions on a statistical analysis of 19 published trials involving 33,826 patients. This so-called meta-analysis found that patients who inhaled the long-acting beta-agonists salmeterol (trade names Serevent and Advair, both made by GlaxoSmithKline) or formoterol (trade name Foradil, made by Novartis Pharmaceuticals) were 3.5 times more likely to die from asthma and 2.5 times more likely to be hospitalized (whether or not death resulted), compared with those taking a placebo.

The reason, say the researchers, is because although these medications relieve asthma symptoms, they also promote bronchial inflammation and sensitivity without warning.

Asthma death is relatively rare, 15 patients in the meta-analysis who were taking the beta-agonists died, compared with three in the placebo group, over a six-month period.

"In total, there are about 5,000 deaths a year due to asthma, whether or not a person is taking a long-acting beta-agonist," said Edwin Salpeter, the J.G. White Distinguished Professor of Physical Sciences Emeritus at Cornell, who led the statistical analysis in the study.

An eminent astrophysicist, Salpeter has more recently focused his attention on medical statistics.

"We can show that overall it is statistically significant that, compared to patients taking a placebo, these long-acting beta-agonists kill a lot of people," he said.

"These asthma deaths are generally in healthy young adults," said his daughter, Shelley Salpeter, the lead author of the paper appearing online and in the June 20 issue of Annals of Internal Medicine. She is a clinical professor of medicine at Stanford's School of Medicine and a physician at Santa Clara Valley Medical Center in San Jose, Calif.

"We estimate that approximately 4,000 out of the 5,000 asthma deaths that occur in the U.S. each year are actually caused by these long-acting beta-agonists, and we urge that these agents be taken off the market," she added.

Adding an anti-inflammatory drug to a long-acting beta-agonist adds little benefit, report the Salpeters.

Advair, for example, (the fourth bestselling drug in the world with $5.6 billion in annual sales), combines salmeterol with an anti-inflammatory drug to provide some protection against bronchial inflammation associated with beta-agonists. But hospitalizations still doubled for patients inhaling a long-acting beta-agonist combined with an anti-inflammatory drug compared with asthma patients taking a placebo and an anti-inflammatory drug by itself.

Of the 19 studies surveyed in the meta-analysis, the largest the Salmeterol Multicenter Asthma Research Trial with 26,000 participants reported a fourfold increased risk for asthma-related deaths and a twofold increase in life-threatening asthma events in patients using salmeterol.

If older people who also suffered from chronic obstructive pulmonary disease were removed from the analysis, the Salpeters report, salmeterol would be associated with a six times greater risk for asthma-related deaths.

The meta-analysis found that 53 of 3,083 patients inhaling beta-agonists were hospitalized for an asthma attack compared with 12 of 2,008 patients who received a placebo, meaning that there was one hospitalization for every 71 patients treated with a long-acting beta-agonist per year.

The Salpeters say that these two long-acting beta-agonists can result in death because tolerance to them develops over time.

"These agents can improve symptoms through bronchodilation at the same time as increasing underlying inflammation and bronchial hyper-responsiveness, thus worsening asthma control without any warning of increased symptoms," said Shelley Salpeter.

"It is particularly frightening that long-acting beta-agonists are detrimental, whether salmeterol or formoterol, whether taken alone or with anti-inflammatory drugs, both for children and for adults," said Ed Salpeter.

Asthma inhalers causing deaths - study

Tue, 20 Jun 2006 00:00:00 -0400

Three asthma inhalers with salmeterol or formoterol may cause 80 percent of U.S. asthma deaths annually, says a new study.

Because of the possible health risks, these products sold as GlaxoSmithKline's Serevent and Advair, and Novartis' Foradil should be recalled, said researchers at Cornell University and Stanford University.

"These asthma deaths are generally (occurring) in healthy young adults," said Stanford researcher Shelly Salpeter. "We estimate that approximately 4,000 of the 5,000 asthma deaths that occur in the U.S. each year are caused by these long-acting beta-agonists, and we urge that (they) be taken of the market."

The researchers conducted a statistical analysis of 19 published asthma trials involving 33,826 patients and found that people who used salmeterol-based asthma inhalers (Serevent and Advair) or inhalers containing formoterol (Foradil) were 3.5 times more likely to die from asthma.

The team also saw that these same patients were 2.5 times more likely to be hospitalized than asthma patients using a placebo inhaler.

Both drugs are in a drug class known as long-acting beta-agonists.

The researchers said that, although beta-agonists relieve bronchial spasm, they also promote bronchial inflammation and sensitivity without warning. Although Advair contains an anti-inflammatory to correct this problem, hospitalizations of patients taking Advair were still double those of people who took a placebo plus an anti-inflammatory, the team noted.

The study authors, whose paper appears in the June 20 issue of the Annals of Internal Medicine, noted that asthma death is relatively rare. Only 15 study patients who were taking the drugs died, compared to three in the placebo group over a six-month period, they said.

Common Asthma Inhalers Cause Up to 80% of Asthma-Related Deaths, Cornell and Stanford Researchers Assert

Fri, 09 Jun 2006 00:00:00 -0400

Three common asthma inhalers containing the drugs salmeterol or formoterol may be causing four out of five U.S. asthma-related deaths per year and should be taken off the market, researchers from Cornell and Stanford universities have concluded after a search of medical literature.

They base these conclusions on a statistical analysis of 19 published trials involving 33,826 patients. This so-called meta-analysis found that patients who inhaled the long-acting beta-agonists salmeterol (trade names Serevent and Advair, both made by GlaxoSmithKline) or formoterol (trade name Foradil, made by Novartis Pharmaceuticals) were 3.5 times more likely to die from asthma and 2.5 times more likely to be hospitalized (whether or not death resulted), compared with those taking a placebo.

The reason, say the researchers, is because although these medications relieve asthma symptoms, they also promote bronchial inflammation and sensitivity without warning.

Nevertheless, asthma death is relatively rare 15 patients in the meta-analysis who were taking the beta-agonists died, compared with three in the placebo group, over a six-month period.

"In total, there are about 5,000 deaths a year due to asthma, whether or not a person is taking a long-acting beta-agonist," said Edwin Salpeter, the J.G. White Distinguished Professor of Physical Sciences Emeritus at Cornell, who led the statistical analysis in the study. An eminent astrophysicist, Salpeter has more recently focused his attention on medical statistics. "We can show that overall it is statistically significant that, compared to patients taking a placebo, these long-acting beta-agonists kill a lot of people," he said.

"These asthma deaths are generally in healthy young adults," said his daughter, Shelley Salpeter, the lead author of the paper appearing online and in the June 20 issue of Annals of Internal Medicine. She is a clinical professor of medicine at Stanford's School of Medicine and a physician at Santa Clara Valley Medical Center in San Jose, Calif.

"We estimate that approximately 4,000 out of the 5,000 asthma deaths that occur in the U.S. each year are actually caused by these long-acting beta-agonists, and we urge that these agents be taken off the market," she added.

Adding an anti-inflammatory drug to a long-acting beta-agonist adds little benefit, report the Salpeters. Advair, for example, (the fourth bestselling drug in the world with $5.6 billion in annual sales), combines salmeterol with an anti-inflammatory drug to provide some protection against bronchial inflammation associated with beta-agonists. But hospitalizations still doubled for patients inhaling a long-acting beta-agonist combined with an anti-inflammatory drug compared with asthma patients taking a placebo and an anti-inflammatory drug by itself.

Of the 19 studies surveyed in the meta-analysis, the largest the Salmeterol Multicenter Asthma Research Trial with 26,000 participants reported a fourfold increased risk for asthma-related deaths and a twofold increase in life-threatening asthma events in patients using salmeterol. If older people who also suffered from chronic obstructive pulmonary disease were removed from the analysis, the Salpeters report, salmeterol would be associated with a six times greater risk for asthma-related deaths.

The meta-analysis found that 53 of 3,083 patients inhaling beta-agonists were hospitalized for an asthma attack compared with 12 of 2,008 patients who received a placebo, meaning that there was one hospitalization for every 71 patients treated with a long-acting beta-agonist per year.

The Salpeters say that these two long-acting beta-agonists can result in death because tolerance to them develops over time.

"These agents can improve symptoms through bronchodilation at the same time as increasing underlying inflammation and bronchial hyper-responsiveness, thus worsening asthma control without any warning of increased symptoms," said Shelley Salpeter.

"It is particularly frightening that long-acting beta-agonists are detrimental, whether salmeterol or formoterol, whether taken alone or with anti-inflammatory drugs, both for children and for adults," said Ed Salpeter.

Co-authors of the study include Shelley Salpeter's son, Nicholas Buckley, a student at Sequoia High School in Redwood City, Calif., and Thomas Ormiston, a physician at Santa Clara Valley Medical Center in San Jose, Calif.

SOURCE: Cornell University

Study Cites Increased Death Risk From Asthma Drugs

Tue, 06 Jun 2006 00:00:00 -0400

Popular and long-acting asthma medicines such as Advair and Serevent pose a substantially increased risk of hospitalization and death to users compared with placebos, according to a new analysis of 19 studies on the subject.

The analysis also found that the increased risks of the long-acting bronchodilators affect a broad range of users more than doubling the rate at which asthma patients had to be hospitalized. Most experts have believed that the powerful bronchodilators are harmful only to a small number of people genetically predisposed to having a negative reaction.

"What we have here is a drug that increases the number of people who will die from the disease it is treating," said lead author Shelley Salpeter of Stanford University. "The long-acting bronchodilators can help reduce symptoms for many people, but we think the price in terms of serious side effects and deaths is unacceptable."

The Food and Drug Administration has voiced concerns about the widely used medicines, and last fall it required drugmakers to prepare stiff new warnings to the package label. But the new analysis, published in the journal Annals of Internal Medicine, raises the possibility that the drug should be taken off the market if it continues to be so widely used.

"The use of long-acting [bronchodilators] could be associated with a clinically significant number of unnecessary hospitalizations, intensive care unit admissions and deaths each year," the authors wrote. "Black box warnings on the labeling for these agents clearly outline the increased risk for asthma-related deaths associated with their use, but these warnings have not changed prescribing practices of physicians."

One of the long-lasting bronchodilators is Advair Diskus, made by GlaxoSmithKline. It brought in $3.4 billion last year for the company, making it the nation's fifth biggest-selling drug, according to IMS Health, which tracks health data.

More than 3.5 million patients use the drug. In the new analysis, the authors estimated that Advair "may be responsible" for as many as 4,000 of the 5,000 asthma-related deaths each year in the United States.

Glaxo spokeswoman Mary Anne Rhyne disputed that figure and said the Centers for Disease Control and Prevention has found a decline in asthma-related deaths since the long-acting bronchodilators came on the market in the mid-1990s.

Rhyne said Advair has been recommended for use in treatment guidelines for asthma from the National Institutes of Health because it reduces symptoms and allows asthma sufferers to sleep through the night, exercise and generally resume normal lives.

"The author's conclusions are inconsistent with a large body of evidence and experience of patients," she said.

She also said doctors have written more than 68 million prescriptions for Advair in the United States since 2001, so there is extensive experience with its benefits and risks.

The new generation of bronchodilators, known as long-acting beta-agonists or LABAs, have been both popular and controversial for some time. The FDA added a black-box warning about their risks in 2003, and last year additional concerns led to an FDA advisory panel meeting to discuss whether they should be taken off the market. The panel concluded that they should not.

As a result of the meeting, however, the agency demanded stronger language in the black-box warning and issued a public health advisory in November that said: "Even though LABAs decrease the frequency of asthma episodes, these medicines may make asthma episodes more severe when they occur. . . . LABAs should not be the first medicine used to treat asthma. LABAs should be added to the asthma treatment plan only if other medicines do not control asthma, including the use of low-or-medium dose corticosteroids."

The new meta-analysis looked at results of 19 trials that studied 33,826 asthma sufferers given either the long-acting bronchodilators or inactive placebos. (Slightly half of both groups were also taking inhaled steroids.) Salpeter said the results found that people on the long-acting medication were four to six times more likely to die of asthma-related causes than those on placebo.

Inhaled steroids, which have long been used to treat asthma, work by reducing the hypersensitivity in the lungs that leads to inflammation and narrowing of the airways. LABAs work by helping to relax the muscles around the airways in the lungs and thereby reduce wheezing. In addition to Advair, Glaxo sells another LABA drug, Serevent, and Novartis sells Foradil.

Glaxo and the FDA have long sparred over how to describe the potential risks of Advair and Serevent. When the agency said last November that the black-box warning needed to be made tougher, Glaxo publicly opposed the move. The tougher warning that the drug could increase the risk of asthma-related death was approved in March. It also said Advair should be prescribed only when other drugs have proved insufficient.

Some research has suggested that LABAs are more likely to harm African Americans than other groups.

Serevent Exposes Blacks to Higher Risk of Asthma-Related Death – Study

Wed, 22 Feb 2006 00:00:00 -0500

A new study has found that GlaxoSmithKline’s (GSK) popular asthma drug, Serevent, (salmeterol), exposes African-American patients to a higher risk of asthma-related death.

The study was led by Dr. Harold S. Nelson, professor of medicine, allergy and immunology at the National Jewish Medical and Research Center in Denver, Colorado.

Serevent is a member of the beta agonist class of asthma medications, which treat asthma symptoms by relaxing inflamed airways.
According to Dr. Nelson: "The bottom line is that in a very large study in which salmeterol or a placebo was added to whatever treatment patients already were on, there was an increased number of severe asthma attacks, including fatal attacks.

The researchers analyzed data from 1996 to 2003, looking at the harmful side effects of salmeterol among more than 26,000 males and females over 12 years of age.

All subjects were asthma sufferers already taking some form of asthma medication other than inhaled beta antagonists. In the year before the study, over 25% of the subjects had visited an emergency room as a result of an asthma attack and 8% had been hospitalized.

Over a 28-week period, each patient used a salmeterol inhaler or a placebo inhaler twice a day along with their current drug regimen.

The study, published in the January issue of Chest, found that white patients on either salmeterol or a placebo showed almost no difference in the number of life-threatening or fatal respiratory or asthma-related episodes.

The researchers noted that before the study began, blacks reported had higher hospitalization and emergency room visit rates due to asthma.
(Source: NewsTarget.com 2.21.06)

Dealing With Asthma

Mon, 27 Jun 2005 00:00:00 -0400

When Patricia Keys first discovered she had asthma, her world came tumbling down.

Despite the fact her family had a long history with the disease, she never imagined it would happen to her because it was not in her childhood, but in her adult life at 49 when she was diagnosed.

After the shocking diagnosis, Keys laid in a hospital bed for three years battling against a disease that has no cure, but she learned it can be controlled with medical treatment.

As a first soprano in her church choir, she also worried about what may happen to her voice.

Over time, Keys not only began to feel better, but she also learned to cope with the disease.

Asthma is a chronic disease of the lungs that results in constriction and irritation of the airways, affecting 20.3 million Americans, according to the American Academy of Allergy, Asthma and Immunology.

"I think the problem was that I didn't know anything about the disease or what triggered it," Keys, 57, said. At all times she carries an Advair diskus, a preventive medicine, and also an inhaler, commonly used to treat asthma attacks.

For asthma patients, a combination of constriction and irritation of the airways can lead to asthma attacks that can be deadly.

The most important aspect of coping with asthma is to learn what induces attacks, said Dr. Benjamin Oyefara, of the Asthma and Allergy Center, who has been treating Keys.

"Knowledge is power," Oyefara said, whose clinic is in its highest demand during fall and spring when pollen and other allergens are prevalent. "You need to know what triggers your asthma."

Oyefara also said he constantly tells people they need to make a conscious effort to understand what factors worsen their condition and simply avoid them as much as possible.

But they also need to take their controller medications including inhaled steroids which prevent asthma attacks, Oyefara said.

Allergens including indoor pollution, dust mites, cockroaches, pets and pollen can have a negative effect, in particular on children who may be at risk during play, Oyefara said.

Oyefara said about 50 percent of children or teenagers do not take their preventive medication, which can be detrimental.

Although it is impossible to avoid indoor pollution completely, people can make an effort to improve the air quality of their homes, he said.

Other triggers can come from irritants including cigarette smoke, strong perfumes and chemicals. Plant fumes can also have a negative effect on the lungs.

But the goal, Oyefara said, is to help people with asthma to have a normal life as much as possible.

Keys said she has recovered her soprano voice now, after having to change keys when her condition is uncontrolled. She credits it to the treatment she has faithfully followed.

She sings at the Praise Chorale at her church, the Riverside Missionary Baptist Church.

"The only things I regret is not being able to eat chocolate, corn bread, tomato sauces," Keys said. "But it is worth it."

For Keys, asthma is partly hereditary, but other factors include physical activity, anxiety, stress or an allergic or environmental reaction.

"The key to maintaining a good quality of life is to avoid the triggers and follow the doctor's instructions," Oyefara said. "Prevention is cheaper and better because asthma can kill."

Salmeterol Warning Cites Risk of Asthma Deaths

Wed, 01 Oct 2003 00:00:00 -0400

The labels of three GlaxoSmithKline asthma products containing salmeterol now have boxed warnings citing a "small but significant increase in asthma-related deaths," based on recommendations from the Food and Drug Administration.

The interim results of a study of approximately 29,000 asthma patients in the Salmeterol Multi-Center Asthma Research Trial (SMART) showed more asthma-related deaths and life-threatening asthmatic episodes among African American patients taking salmeterol than among those taking a placebo.

The products with label changes are Serevent Inhalation Aerosol (salmeterol xinafoate), Serevent Diskus (salmeterol xinafoate inhalation powder), and Advair Diskus (fluticasone propionate and salmeterol inhalation powder). Serevent Diskus is approved for treatment of asthma in patients aged 4 years and older, while both Serevent Inhalation Aerosol and Advair Diskus are approved for patients aged 12 years and older.

The "Dear Healthcare Professional" letter included with the products states that patients currently taking these medications should not stop suddenly this may lead to life-threatening asthmatic episodes due to uncontrolled asthma. In addition, the letter reminds physicians that patients taking salmeterol as their only asthma therapy should add an inhaled corticosteroid to their treatment regimens.

However, the warning implies a much broader problem than exists, Dr. Harold Nelson, professor of medicine at the National Jewish Medical and Research Center, Denver, told this newspaper. The adverse outcomes occurred in patients who were not only African American, but who were not taking inhaled corticosteroids. Those taking inhaled corticosteroids concurrently with salmeterol had no adverse effects, regardless of ethnicity.

In a 28-week safety study, asthma patients aged 12 years and older were given either 42 [micro]g of salmeterol or a placebo twice daily. Although the study was meant to include approximately 60,000 patients, it was stopped at the halfway point due to evidence of increased risk of asthma-related deaths among patients who received salmeterol: 13 deaths among 13,174 patients, compared with 4 asthma-related deaths among 13,179 patients who received placebo. Approximately 17% of the study subjects were African American.

The SMART study did not include outcome analyses based on demographic traits, but a later subgroup analysis showed a statistically significant increase in the number of asthma-related deaths among African American patients who received salmeterol compared with those who received placebo (eight vs. one). In addition, a weakness of the SMART study is that the only information about concomitant medication is the form that patients filled out at the beginning of the study, Dr. Nelson noted.

However, the FDA maintains that the benefits of salmeterol outweigh the risks when patients with asthma and chronic obstructive pulmonary disease use the medication properly and that includes taking inhaled corticosteroids concomitantly.

Asthma Disease Injury Lawsuits Linked To Side Effects Associated With Prescription Drugs, Such As: Advair, Serevent

Wed, 01 Oct 2003 00:00:00 -0400

Asthma Disease Injury Lawsuits

Asthma | Lawsuits, Lawyers | Disease: Injury, Infection | Side Effects, Prescription Drugs, Advair, Serevent

Asthma is a chronic disease of the lungs in which the airways become blocked or narrowed causing breathing difficulties. Asthma affects more than 20 million people in the United States and is divided into two types: allergic (extrinsic) asthma and non-allergic (intrinsic) asthma.

Allergic (extrinsic) asthma is associated with symptoms that are triggered by an allergic reaction. Allergic asthma is airway obstruction and inflammation that is partially reversible with medication. Allergic asthma is the most common form of asthma. Allergic asthma is triggered by inhaled allergens such as dust mite allergen, pet dander, pollen, mold, etc. resulting in asthma symptoms.

Non-Allergic (intrinsic) asthma is set off by factors not related to allergies. Like allergic asthma, non-allergic asthma is characterized by airway obstruction and inflammation that is at least partially reversible with medication; however symptoms in this type of asthma are NOT associated with an allergic reaction. Non-allergic asthma is triggered by other factors such as anxiety, stress, exercise, cold air, dry air, hyperventilation, smoke, viruses or other irritants. In non-allergic asthma, the immune system is not involved in the reaction.

Many of the symptoms of allergic and non-allergic asthma are the same: coughing, wheezing, shortness of breath or rapid breathing, and chest tightness).

On July 14, 2005, the FDA cleared asthma drugs Advair and Serevent, allowing them to stay on the market as long as warning labels clearly alert patients to potential risks. Made by GlaxoSmithKline, the medications contain salmeterol, a bronchodilator known as a beta2-against.

It works by relaxing the bronchial muscles, thereby improving air flow for many of the 15 million asthma sufferers in the U.S. Regulators became alarmed when Glaxo reported that it had to stop tests of the drug when about 50 out of 26,000 patients being studied suffered more severe asthma attacks.

A few died. After a review by its panel of experts, the FDA voted 12-0 to keep the drugs on the market while adding a "black box" warning, the most extreme warning that can be put on drugs.

Legal Help For Victims Affected By Asthma

If you or a loved one has taken asthma medications and suffered side effects or your asthma has worsened, please fill out the form at the right for a free case evaluation by a qualified defective drug attorney or call us at 1-800-LAW-INFO (1-800-529-4636).