The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.
Terbutaline is FDA-approved to prevent and treat narrowing of the airways (bronchospasm) associated with asthma, bronchitis, and emphysema. The drug is used off-label for obstetric purposes, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used in an attempt to prevent recurrent preterm labor. There is no evidence, however, that use of terbutaline to prevent preterm labor improves infant outcomes. Serious adverse events, including maternal deaths, have been reported with such use in pregnant patients.
“Women should be aware that serious and sometimes fatal side effects have been reported after prolonged use of terbutaline in pregnant women,” said Scott Monroe, M.D., director of FDA’s Division of Reproductive and Urologic Products. “It is important for patients and health care professionals to consider all the potential risks and known benefits of any drug before deciding on its use.”
The FDA is aware that administration of terbutaline by injection to pregnant women is used in hospital settings in certain urgent situations. The FDA warning relates to safety concerns about the prolonged use of terbutaline injection beyond 48-72 hours, and against any use of oral terbutaline in pregnant women for prevention or treatment of preterm labor.
The decision to require a Boxed Warning and Contraindication is based on the FDA’s review of post-market safety reports of heart problems and even death associated with terbutaline use for obstetric indications, as well as data from medical literature documenting the lack of safety and effectiveness of terbutaline for preventing preterm labor, and animal data suggesting potential risks. Based on this information, the FDA concluded that the risk of serious adverse events outweighs any potential benefit to pregnant patients for either prolonged use of terbutaline injection beyond 48-72 hours or use of oral terbutaline for prevention or treatment of preterm labor.
These changes to the drug labeling are consistent with statements from the American College of Obstetricians and Gynecologists discouraging use of terbutaline for preventing preterm labor.
There are multiple generic versions of terbutaline oral tablets and injectable formulations available. The brand name products were previously discontinued by the companies that made them.
The FDA encourages patients to talk to their health care professional if they have concerns about any treatment they are receiving. Patients and health care professionals should report any side effects from the use of terbutaline to the FDA’s MedWatch adverse event reporting program at www.fda.gov/MedWatch1.
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Showing posts with label asthma. Show all posts
Showing posts with label asthma. Show all posts
Wednesday, February 23, 2011
Wednesday, September 15, 2010
September Named “Mold Awareness Month”
As National Mold Cases Rise, Local Experts Warn of Increased Health Risks
As documented cases of residential mold contamination and related health problems continue to rise across the nation, the indoor air quality industry is on a crusade to educate homeowners about the serious consequences of mold in the home. (September 5 – October 5) has been deemed Mold Awareness Month by the industry because mold spores that commonly grow in summer humidity are often trapped as people close up homes and foundation vents in the fall. Just a few of these spores can make a family sick.
Consider This:
There are an estimated 10,000 mold-related court cases nationwide
There has been a 300 percent increase in litigation involving mold contamination over the past five years.
The average mold claim costs $35,000 and many exceed $100,000.
“We know to check the batteries in our smoke detectors, to change our air filters, to clean out our gutters and rake our leaves, but no one talks to homeowners about the dangers of household mold,” says Jeff Dudan, CEO and founder of AdvantaClean, a national mold remediation company with a locally owned franchise serving the area. “We’re on a mission to teach homeowners how to limit mold growth and keep their families healthy.”
Fast Facts about Mold:
According to the U.S. EPA, the air inside the average American home can be more than 100 times more polluted than the air outside. New homes usually have poorer air quality than older homes because they’re air tight, so spores can’t escape, providing a perfect breeding ground.
Common household molds cause asthma, sneezing, runny nose, red eyes and skin rashes. Infants and the elderly are most the at risk, because they often have weaker immune systems.
Mold is prevalent in most homes and it’s often difficult to eradicate, but all mold requires moisture to grow, so reducing moisture will reduce mold growth.
Where Mold Grows:
Windowsills, closets, wall paper, flooring, in or around showers, dishwashers, washing machines, and even in the soil of potted plants.
Mold can be caused by slow dripping pipes, condensation, standing water on or under carpets and floor boards, leaky dryer vents, broken shingles and wet insulation.
Preventions and Control:
When water leaks, ACT QUICKLY. If you dry wet materials 24 – 48 hours after a leak or spill, mold will not grow in most cases.
Clean and repair roof gutters and leaky roofs regularly.
Point sprinklers away from the home and siding.
Make sure landscapes slope away from your home’s foundation so water doesn’t collect.
Keep relative indoor humidity low, if possible below 60 percent. Humidity is measured most accurately with a moisture meter, a small $10 - $50 instrument found at most hardware stores.
Use air conditioners and dehumidifiers regularly.
Run the bathroom fan or open the window when showering and up to 10 minutes afterward.
Use exhaust fans or open widows whenever cooking, running the dishwasher or even washing dishes.
Source: AdvantaClean
-----
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As documented cases of residential mold contamination and related health problems continue to rise across the nation, the indoor air quality industry is on a crusade to educate homeowners about the serious consequences of mold in the home. (September 5 – October 5) has been deemed Mold Awareness Month by the industry because mold spores that commonly grow in summer humidity are often trapped as people close up homes and foundation vents in the fall. Just a few of these spores can make a family sick.
Consider This:
There are an estimated 10,000 mold-related court cases nationwide
There has been a 300 percent increase in litigation involving mold contamination over the past five years.
The average mold claim costs $35,000 and many exceed $100,000.
“We know to check the batteries in our smoke detectors, to change our air filters, to clean out our gutters and rake our leaves, but no one talks to homeowners about the dangers of household mold,” says Jeff Dudan, CEO and founder of AdvantaClean, a national mold remediation company with a locally owned franchise serving the area. “We’re on a mission to teach homeowners how to limit mold growth and keep their families healthy.”
Fast Facts about Mold:
According to the U.S. EPA, the air inside the average American home can be more than 100 times more polluted than the air outside. New homes usually have poorer air quality than older homes because they’re air tight, so spores can’t escape, providing a perfect breeding ground.
Common household molds cause asthma, sneezing, runny nose, red eyes and skin rashes. Infants and the elderly are most the at risk, because they often have weaker immune systems.
Mold is prevalent in most homes and it’s often difficult to eradicate, but all mold requires moisture to grow, so reducing moisture will reduce mold growth.
Where Mold Grows:
Windowsills, closets, wall paper, flooring, in or around showers, dishwashers, washing machines, and even in the soil of potted plants.
Mold can be caused by slow dripping pipes, condensation, standing water on or under carpets and floor boards, leaky dryer vents, broken shingles and wet insulation.
Preventions and Control:
When water leaks, ACT QUICKLY. If you dry wet materials 24 – 48 hours after a leak or spill, mold will not grow in most cases.
Clean and repair roof gutters and leaky roofs regularly.
Point sprinklers away from the home and siding.
Make sure landscapes slope away from your home’s foundation so water doesn’t collect.
Keep relative indoor humidity low, if possible below 60 percent. Humidity is measured most accurately with a moisture meter, a small $10 - $50 instrument found at most hardware stores.
Use air conditioners and dehumidifiers regularly.
Run the bathroom fan or open the window when showering and up to 10 minutes afterward.
Use exhaust fans or open widows whenever cooking, running the dishwasher or even washing dishes.
Source: AdvantaClean
-----
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Wednesday, August 18, 2010
Studies Link Range of Major Diseases to Pesticides, New Database Launched
/PRNewswire/ -- Links to pesticide exposure are being found in a growing number of studies that evaluate the causes of preventable diseases -- including asthma, autism and learning disabilities, birth defects and reproductive dysfunction, diabetes, Parkinson's and Alzheimer's diseases, and several types of cancer. A new database, released today, tracks published epidemiologic and real world exposure studies. The studies challenge the effectiveness of risk-assessment-based regulation which is intended to manage adverse disease outcomes, but is criticized for allowing the uses of chemicals that can be replaced by green technologies and practices.
To capture the range of diseases linked to pesticides through epidemiologic studies, the national environmental and public health group Beyond Pesticides launched in the summer issue of its newsletter, Pesticides and You, the Pesticide-Induced Diseases Database to track the studies. "A read through the scientific literature on pesticides and major preventable diseases afflicting us in the 21st century suggests that one of the first responses called for is an all out effort to stop using toxic pesticides," said Jay Feldman, executive director of Beyond Pesticides. The database begins an ongoing effort by Beyond Pesticides to maintain this comprehensive database of the studies that the group says "supports an urgent need to shift to toxic-free practices and policies."
The group is calling for alternatives assessment in environmental rulemaking that creates a regulatory trigger to adopt alternatives and drive the market to go green. "Under risk assessment, we constantly play with 'mitigation measures' that the Pesticide-Induced Diseases Database tells us over and over is a failed human experiment," said Mr. Feldman.
The alternatives assessment approach differs most dramatically from risk assessment in rejecting uses and exposures deemed acceptable under risk assessment calculations, but unnecessary because of the availability of safer alternatives. For example, in agriculture, where the database shows clear links to pesticide use and multiple types of cancer, it would no longer be possible to use hazardous pesticides, as it is with risk assessment-based policy, when there are clearly effective organic systems with competitive yields that, in fact, outperform chemical-intensive agriculture in drought years. This same analysis can be applied to home and garden use of pesticides where households using pesticides suffer elevated rates of cancer.
Earlier this year Beyond Pesticides released its Organic Food: Eating with a Conscience guide that explains how foods grown with hazardous chemicals contaminate water and air, hurt biodiversity, harm farmworkers, and kill bees, birds, fish and other wildlife even though the finished commodities, often referred to as "clean," may have minimal or nondetectable residues. The guide can be found at www.eatingwithaconscience.org.
The Pesticide-Induced Diseases Database, which currently contains 383 entries of epidemiologic and laboratory exposure studies, will be continually updated to track the emerging findings and trends. To view the database, go to www.beyondpesticides.org/health.
-----
Community News You Can Use
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter: @GAFrontPage
To capture the range of diseases linked to pesticides through epidemiologic studies, the national environmental and public health group Beyond Pesticides launched in the summer issue of its newsletter, Pesticides and You, the Pesticide-Induced Diseases Database to track the studies. "A read through the scientific literature on pesticides and major preventable diseases afflicting us in the 21st century suggests that one of the first responses called for is an all out effort to stop using toxic pesticides," said Jay Feldman, executive director of Beyond Pesticides. The database begins an ongoing effort by Beyond Pesticides to maintain this comprehensive database of the studies that the group says "supports an urgent need to shift to toxic-free practices and policies."
The group is calling for alternatives assessment in environmental rulemaking that creates a regulatory trigger to adopt alternatives and drive the market to go green. "Under risk assessment, we constantly play with 'mitigation measures' that the Pesticide-Induced Diseases Database tells us over and over is a failed human experiment," said Mr. Feldman.
The alternatives assessment approach differs most dramatically from risk assessment in rejecting uses and exposures deemed acceptable under risk assessment calculations, but unnecessary because of the availability of safer alternatives. For example, in agriculture, where the database shows clear links to pesticide use and multiple types of cancer, it would no longer be possible to use hazardous pesticides, as it is with risk assessment-based policy, when there are clearly effective organic systems with competitive yields that, in fact, outperform chemical-intensive agriculture in drought years. This same analysis can be applied to home and garden use of pesticides where households using pesticides suffer elevated rates of cancer.
Earlier this year Beyond Pesticides released its Organic Food: Eating with a Conscience guide that explains how foods grown with hazardous chemicals contaminate water and air, hurt biodiversity, harm farmworkers, and kill bees, birds, fish and other wildlife even though the finished commodities, often referred to as "clean," may have minimal or nondetectable residues. The guide can be found at www.eatingwithaconscience.org.
The Pesticide-Induced Diseases Database, which currently contains 383 entries of epidemiologic and laboratory exposure studies, will be continually updated to track the emerging findings and trends. To view the database, go to www.beyondpesticides.org/health.
-----
Community News You Can Use
www.fayettefrontpage.com
Fayette Front Page
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Monday, December 22, 2008
Concerned for Your Child's Asthma? Pollution Near Schools May Be the Problem
/PRNewswire-USNewswire/ -- The nation's focus has returned to the safety of our schools with the second article by USA TODAY in a series on school siting. Working closely with the Center for Health, Environment & Justice (CHEJ), USA TODAY examined the environmental danger of a school located in the shadow of one of our nation's largest oil refineries. Wyandotte Early Education Center serves local 4 year-olds, whose developing lungs are particularly susceptible to the sulfuric acid, naphthalene, ammonia and benzene that the ExxonMobil plant belches into the surrounding air.
The refinery has already been fined by the EPA for failing to monitor and control sulfur gasses that can cause respiratory illness as part of $6.1 million dollars in penalties levied against ExxonMobil last week. Meanwhile, local doctors take note of unusually high rates of asthma and respiratory illness among students.
"Asthma is a direct result of air pollution and asthma is the number one reason for school absences," said Lois Gibbs, Executive Director of CHEJ. "Industries that are permitted to release toxics into the air must be monitored very carefully and, if in violation, brought into compliance immediately. Too often the industry gets away with violations over and over again without serious penalties. We protect our children by law with seat belts, car seats, bike helmets, and from negligent and abusive parents - toxic pollution should be no different." CHEJ recommends adopting the following model laws for states and as guidelines for the EPA http://www.childproofing.org/school_siting_model_legislation.htm
In December 2007, President Bush signed Subtitle E of the Energy Independence and Security Act of 2007, instructing the EPA to develop the nation's first-ever school siting guidelines to give state legislatures direction in where schools may be physically located in relationship to toxic contamination sites. The EPA has been given a deadline of June, 2009. Nothing has been done since congress passed this directive. No one has even been given the responsibility for this task.
Meanwhile, communities struggle to relocate schools away from industrial plants emitting toxic levels of air pollutants. USA Today had identified over 20,000 of these schools located within a half mile of a major industrial plant.
"No one should have to file a lawsuit to ensure that their kids go to school on sites that are weren't used for the disposal of hazardous waste," says Steve Fischbach of Rhode Island Legal Services who has fought legal battles to pass rudimentary school siting guidelines in Rhode Island.
-----
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Fayette Front Page
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Georgia Front Page
The refinery has already been fined by the EPA for failing to monitor and control sulfur gasses that can cause respiratory illness as part of $6.1 million dollars in penalties levied against ExxonMobil last week. Meanwhile, local doctors take note of unusually high rates of asthma and respiratory illness among students.
"Asthma is a direct result of air pollution and asthma is the number one reason for school absences," said Lois Gibbs, Executive Director of CHEJ. "Industries that are permitted to release toxics into the air must be monitored very carefully and, if in violation, brought into compliance immediately. Too often the industry gets away with violations over and over again without serious penalties. We protect our children by law with seat belts, car seats, bike helmets, and from negligent and abusive parents - toxic pollution should be no different." CHEJ recommends adopting the following model laws for states and as guidelines for the EPA http://www.childproofing.org/school_siting_model_legislation.htm
In December 2007, President Bush signed Subtitle E of the Energy Independence and Security Act of 2007, instructing the EPA to develop the nation's first-ever school siting guidelines to give state legislatures direction in where schools may be physically located in relationship to toxic contamination sites. The EPA has been given a deadline of June, 2009. Nothing has been done since congress passed this directive. No one has even been given the responsibility for this task.
Meanwhile, communities struggle to relocate schools away from industrial plants emitting toxic levels of air pollutants. USA Today had identified over 20,000 of these schools located within a half mile of a major industrial plant.
"No one should have to file a lawsuit to ensure that their kids go to school on sites that are weren't used for the disposal of hazardous waste," says Steve Fischbach of Rhode Island Legal Services who has fought legal battles to pass rudimentary school siting guidelines in Rhode Island.
-----
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Georgia Front Page
Friday, November 21, 2008
Is your Christmas Tree making You Ill
TT Note: There's no doubt live trees in the house can aggravate allergies and asthma. The allergists in Fayette County recommend no live trees for homes whose occupants have allergies. Washing down the artificial tree as an attempt to lesson mold spores is a great idea.
24-7-- Could it be your Christmas tree that's making you sick? Recent studies tend to support that theory. It seems that Christmas trees, either real or artificial can be a source of mold or allergens that can be the cause of those "sniffles" you seem to have at this time of the year.
In a recent study, mold spores in an apartment had a normal range of 500-700 spores per cubic meter. When the Christmas tree was added, the spores measured about 800 spores per cubic meter of air for the first three days. By day 14 the spores count had increased to 5,000 spores per cubic meter. If you have asthma or are prone to sinus infections you are likely to have a problem. The longer you leave the tree up the worse the contamination.
An artificial tree, stored in the attic or basement for a year can pose many of the same problems. It can acquire pollens, dust or mold. Taking the tree outdoors and washing it down can help. But that isn't always possible due to cold temperatures of the season.
Minnesota based WorldWide Oxide markets and EPA approved GREEN mold preventer Vital Oxide. Vital Oxide is totally safe, is odorless, and contains no harmful VOC's states company spokesman Tom Heller. Simply spray Vital Oxide onto the tree every few days during the season, and the mold or allergen problem will not be a factor in your home states Heller. Because Vital Oxide is odorless, you will not have to worry about some cover-up scent destroying your Christmas ambiance.
For more information on the studies visit the WorldWide Oxide web site at http://www.worldwideoxide.com.
-----
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Fayetteville, Peachtree City, Tyrone
www.georgiafrontpage.com
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24-7-- Could it be your Christmas tree that's making you sick? Recent studies tend to support that theory. It seems that Christmas trees, either real or artificial can be a source of mold or allergens that can be the cause of those "sniffles" you seem to have at this time of the year.
In a recent study, mold spores in an apartment had a normal range of 500-700 spores per cubic meter. When the Christmas tree was added, the spores measured about 800 spores per cubic meter of air for the first three days. By day 14 the spores count had increased to 5,000 spores per cubic meter. If you have asthma or are prone to sinus infections you are likely to have a problem. The longer you leave the tree up the worse the contamination.
An artificial tree, stored in the attic or basement for a year can pose many of the same problems. It can acquire pollens, dust or mold. Taking the tree outdoors and washing it down can help. But that isn't always possible due to cold temperatures of the season.
Minnesota based WorldWide Oxide markets and EPA approved GREEN mold preventer Vital Oxide. Vital Oxide is totally safe, is odorless, and contains no harmful VOC's states company spokesman Tom Heller. Simply spray Vital Oxide onto the tree every few days during the season, and the mold or allergen problem will not be a factor in your home states Heller. Because Vital Oxide is odorless, you will not have to worry about some cover-up scent destroying your Christmas ambiance.
For more information on the studies visit the WorldWide Oxide web site at http://www.worldwideoxide.com.
-----
www.fayettefrontpage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.georgiafrontpage.com
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