FDA Announcement: long-acting beta agonists

[mom2lillian]

I'm not saying to get ready to drop your meds or anything just making everyone aware.


FDA NEWS RELEASE
For Immediate Release: Feb. 18, 2010
Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov; Erica Jefferson, 301-796-4988; erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma

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.

The FDA will be requiring the manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA will seek input on the design of these studies at a public advisory committee meeting in March 2010.

In addition to these actions, FDA will work with public and private partners under the agency's ongoing Safe Use Initiative to study LABA prescribing practices.

"We will collaborate with our Safe Use partners to evaluate whether prescribing patterns adjust to the new recommendations for this class of asthma drugs. If prescribing patterns don't adjust, we will determine the reasons and consider additional steps to support safe prescribing," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

The Safe Use Initiative, launched in November, strives to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with public and private partners who are committed to safe medication use.

Advair and Serevent are marketed by Collegeville, PA-based GlaxoSmithKline.
Foradil is marketed by Lebanon, PA-based Novartis AG.
Symbicort is marketed by Wilmington, DE-based AstraZeneca.

Long-Acting Beta Agonist (LABA) Information
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm199565.htm1
">http://www.fda.gov/Drugs/DrugS...gClass/ucm199565.htm1
</a>
Safe Use Initiative
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm2">http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm2</a>

 

[mom2lillian]

I'm not saying to get ready to drop your meds or anything just making everyone aware.


FDA NEWS RELEASE
For Immediate Release: Feb. 18, 2010
Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov; Erica Jefferson, 301-796-4988; erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma

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.

The FDA will be requiring the manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA will seek input on the design of these studies at a public advisory committee meeting in March 2010.

In addition to these actions, FDA will work with public and private partners under the agency's ongoing Safe Use Initiative to study LABA prescribing practices.

"We will collaborate with our Safe Use partners to evaluate whether prescribing patterns adjust to the new recommendations for this class of asthma drugs. If prescribing patterns don't adjust, we will determine the reasons and consider additional steps to support safe prescribing," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

The Safe Use Initiative, launched in November, strives to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with public and private partners who are committed to safe medication use.

Advair and Serevent are marketed by Collegeville, PA-based GlaxoSmithKline.
Foradil is marketed by Lebanon, PA-based Novartis AG.
Symbicort is marketed by Wilmington, DE-based AstraZeneca.

Long-Acting Beta Agonist (LABA) Information
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm199565.htm1
">http://www.fda.gov/Drugs/DrugS...gClass/ucm199565.htm1
</a>
Safe Use Initiative
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm2">http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm2</a>

 

[mom2lillian]

I'm not saying to get ready to drop your meds or anything just making everyone aware.


FDA NEWS RELEASE
For Immediate Release: Feb. 18, 2010
Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov; Erica Jefferson, 301-796-4988; erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma

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.

The FDA will be requiring the manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA will seek input on the design of these studies at a public advisory committee meeting in March 2010.

In addition to these actions, FDA will work with public and private partners under the agency's ongoing Safe Use Initiative to study LABA prescribing practices.

"We will collaborate with our Safe Use partners to evaluate whether prescribing patterns adjust to the new recommendations for this class of asthma drugs. If prescribing patterns don't adjust, we will determine the reasons and consider additional steps to support safe prescribing," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

The Safe Use Initiative, launched in November, strives to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with public and private partners who are committed to safe medication use.

Advair and Serevent are marketed by Collegeville, PA-based GlaxoSmithKline.
Foradil is marketed by Lebanon, PA-based Novartis AG.
Symbicort is marketed by Wilmington, DE-based AstraZeneca.

Long-Acting Beta Agonist (LABA) Information
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm199565.htm1
">http://www.fda.gov/Drugs/DrugS...gClass/ucm199565.htm1
</a>
Safe Use Initiative
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm2">http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm2</a>

 

[mom2lillian]

I'm not saying to get ready to drop your meds or anything just making everyone aware.


FDA NEWS RELEASE
For Immediate Release: Feb. 18, 2010
Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov; Erica Jefferson, 301-796-4988; erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma

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.

The FDA will be requiring the manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA will seek input on the design of these studies at a public advisory committee meeting in March 2010.

In addition to these actions, FDA will work with public and private partners under the agency's ongoing Safe Use Initiative to study LABA prescribing practices.

"We will collaborate with our Safe Use partners to evaluate whether prescribing patterns adjust to the new recommendations for this class of asthma drugs. If prescribing patterns don't adjust, we will determine the reasons and consider additional steps to support safe prescribing," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

The Safe Use Initiative, launched in November, strives to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with public and private partners who are committed to safe medication use.

Advair and Serevent are marketed by Collegeville, PA-based GlaxoSmithKline.
Foradil is marketed by Lebanon, PA-based Novartis AG.
Symbicort is marketed by Wilmington, DE-based AstraZeneca.

Long-Acting Beta Agonist (LABA) Information
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm199565.htm1
">http://www.fda.gov/Drugs/DrugS...gClass/ucm199565.htm1
</a>
Safe Use Initiative
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm2">http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm2</a>

 

[mom2lillian]

I'm not saying to get ready to drop your meds or anything just making everyone aware.
<br />
<br />
<br />FDA NEWS RELEASE
<br />For Immediate Release: Feb. 18, 2010
<br />Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov; Erica Jefferson, 301-796-4988; erica.jefferson@fda.hhs.gov
<br />Consumer Inquiries: 888-INFO-FDA
<br />
<br />FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma
<br />
<br />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.
<br />
<br />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.
<br />
<br />The FDA will now require that the product labels reflect the following:
<br />
<br />.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;
<br />.LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications;
<br />.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.
<br />.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.
<br />"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.
<br />
<br />"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.
<br />
<br />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.
<br />
<br />The FDA will be requiring the manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA will seek input on the design of these studies at a public advisory committee meeting in March 2010.
<br />
<br />In addition to these actions, FDA will work with public and private partners under the agency's ongoing Safe Use Initiative to study LABA prescribing practices.
<br />
<br />"We will collaborate with our Safe Use partners to evaluate whether prescribing patterns adjust to the new recommendations for this class of asthma drugs. If prescribing patterns don't adjust, we will determine the reasons and consider additional steps to support safe prescribing," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.
<br />
<br />The Safe Use Initiative, launched in November, strives to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with public and private partners who are committed to safe medication use.
<br />
<br />Advair and Serevent are marketed by Collegeville, PA-based GlaxoSmithKline.
<br />Foradil is marketed by Lebanon, PA-based Novartis AG.
<br />Symbicort is marketed by Wilmington, DE-based AstraZeneca.
<br />
<br />Long-Acting Beta Agonist (LABA) Information
<br /><a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm199565.htm1
">http://www.fda.gov/Drugs/DrugS...gClass/ucm199565.htm1
</a><br />
<br />Safe Use Initiative
<br /><a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm2">http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm2</a>

 

[Melissa75]

I am not sure if there has been a new study, but these drugs have gone before congress/FDA before. I'll paste a Forbes article below from 2006.

When I asked my dr about it, he said that the risk is in people with asthma who are essentially confused and try to use a LABA the way they used albuterol...as a rescue inhaler. It is NOT so the asthma attack can kill you.

They still recommend the use of Advair or Symbicort in people with COPD. And since I more resemble that patient profile than typical asthma, so I am sticking with my symbicort

I love to read articles though. SO off I go to see what else is being said about LABAs.

Asthma Drug Warning Strengthened
Robert Langreth, 03.03.06, 3:23 PM ET

GlaxoSmithKline

A strict new warning may impact sales of one of the world's top-selling asthma drugs.

GlaxoSmithKline (nyse: GSK - news - people ) said today it had reached an agreement to update its product label for its popular drug Advair with a strict new warning that advises doctors to limit the use of the drug only to patients who are not controlled on other asthma drugs, or have such severe cases.

The agreement comes in the wake of a giant 26,000 patient study, completed several years ago, that found a higher death rate in patients treated with salmeterol, one of the ingredients in Advair. The death data were already in the label in a black-box warning, but now the label also includes specific admonishments to doctors to restrict use of the powerful combination asthma drug to patients who really need it.

"almeterol] one of the active ingredients in ADVAIR DISKUS may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma controller medications...or whose disease severity clearly warrants initiation of treatments with two maintenance therapies," the new label says. Advair contains two medicines, an inhaled steroid to control inflammation, and salmeterol, which improves symptoms by expanding the airways. There also is a new label for Glaxo's Serevent, which just contains salmeterol.

GlaxoSmithKline "is pleased to have reached an agreement with [the] Food and Drug Administration on product labeling that is in the best interest of patients," the company said in a statement.

The agreement, however, appears to represent a partial victory for the FDA, which issued a public healthy advisory last November warning that use of the drug should be limited. At the time, GlaxoSmithKline said that it disagreed with the proposed label change.

Exactly how the new label will impact sales of Advair is not clear. Since the FDA's advisory last fall, Advair sales have continued to grow strongly. However, the new warning makes it official: doctors who use Advair as initial therapy in relatively mild cases would be using the drug off-label. Earlier this year, a GlaxoSmithKline executive insisted to analysts that any downside to a new label was limited since only 6% of Advair use is among patients not previously on asthma medication.

 

[Melissa75]

I am not sure if there has been a new study, but these drugs have gone before congress/FDA before. I'll paste a Forbes article below from 2006.

When I asked my dr about it, he said that the risk is in people with asthma who are essentially confused and try to use a LABA the way they used albuterol...as a rescue inhaler. It is NOT so the asthma attack can kill you.

They still recommend the use of Advair or Symbicort in people with COPD. And since I more resemble that patient profile than typical asthma, so I am sticking with my symbicort

I love to read articles though. SO off I go to see what else is being said about LABAs.

Asthma Drug Warning Strengthened
Robert Langreth, 03.03.06, 3:23 PM ET

GlaxoSmithKline

A strict new warning may impact sales of one of the world's top-selling asthma drugs.

GlaxoSmithKline (nyse: GSK - news - people ) said today it had reached an agreement to update its product label for its popular drug Advair with a strict new warning that advises doctors to limit the use of the drug only to patients who are not controlled on other asthma drugs, or have such severe cases.

The agreement comes in the wake of a giant 26,000 patient study, completed several years ago, that found a higher death rate in patients treated with salmeterol, one of the ingredients in Advair. The death data were already in the label in a black-box warning, but now the label also includes specific admonishments to doctors to restrict use of the powerful combination asthma drug to patients who really need it.

"almeterol] one of the active ingredients in ADVAIR DISKUS may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma controller medications...or whose disease severity clearly warrants initiation of treatments with two maintenance therapies," the new label says. Advair contains two medicines, an inhaled steroid to control inflammation, and salmeterol, which improves symptoms by expanding the airways. There also is a new label for Glaxo's Serevent, which just contains salmeterol.

GlaxoSmithKline "is pleased to have reached an agreement with [the] Food and Drug Administration on product labeling that is in the best interest of patients," the company said in a statement.

The agreement, however, appears to represent a partial victory for the FDA, which issued a public healthy advisory last November warning that use of the drug should be limited. At the time, GlaxoSmithKline said that it disagreed with the proposed label change.

Exactly how the new label will impact sales of Advair is not clear. Since the FDA's advisory last fall, Advair sales have continued to grow strongly. However, the new warning makes it official: doctors who use Advair as initial therapy in relatively mild cases would be using the drug off-label. Earlier this year, a GlaxoSmithKline executive insisted to analysts that any downside to a new label was limited since only 6% of Advair use is among patients not previously on asthma medication.

 

[Melissa75]

I am not sure if there has been a new study, but these drugs have gone before congress/FDA before. I'll paste a Forbes article below from 2006.

When I asked my dr about it, he said that the risk is in people with asthma who are essentially confused and try to use a LABA the way they used albuterol...as a rescue inhaler. It is NOT so the asthma attack can kill you.

They still recommend the use of Advair or Symbicort in people with COPD. And since I more resemble that patient profile than typical asthma, so I am sticking with my symbicort

I love to read articles though. SO off I go to see what else is being said about LABAs.

Asthma Drug Warning Strengthened
Robert Langreth, 03.03.06, 3:23 PM ET

GlaxoSmithKline

A strict new warning may impact sales of one of the world's top-selling asthma drugs.

GlaxoSmithKline (nyse: GSK - news - people ) said today it had reached an agreement to update its product label for its popular drug Advair with a strict new warning that advises doctors to limit the use of the drug only to patients who are not controlled on other asthma drugs, or have such severe cases.

The agreement comes in the wake of a giant 26,000 patient study, completed several years ago, that found a higher death rate in patients treated with salmeterol, one of the ingredients in Advair. The death data were already in the label in a black-box warning, but now the label also includes specific admonishments to doctors to restrict use of the powerful combination asthma drug to patients who really need it.

"almeterol] one of the active ingredients in ADVAIR DISKUS may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma controller medications...or whose disease severity clearly warrants initiation of treatments with two maintenance therapies," the new label says. Advair contains two medicines, an inhaled steroid to control inflammation, and salmeterol, which improves symptoms by expanding the airways. There also is a new label for Glaxo's Serevent, which just contains salmeterol.

GlaxoSmithKline "is pleased to have reached an agreement with [the] Food and Drug Administration on product labeling that is in the best interest of patients," the company said in a statement.

The agreement, however, appears to represent a partial victory for the FDA, which issued a public healthy advisory last November warning that use of the drug should be limited. At the time, GlaxoSmithKline said that it disagreed with the proposed label change.

Exactly how the new label will impact sales of Advair is not clear. Since the FDA's advisory last fall, Advair sales have continued to grow strongly. However, the new warning makes it official: doctors who use Advair as initial therapy in relatively mild cases would be using the drug off-label. Earlier this year, a GlaxoSmithKline executive insisted to analysts that any downside to a new label was limited since only 6% of Advair use is among patients not previously on asthma medication.

 

[Melissa75]

I am not sure if there has been a new study, but these drugs have gone before congress/FDA before. I'll paste a Forbes article below from 2006.

When I asked my dr about it, he said that the risk is in people with asthma who are essentially confused and try to use a LABA the way they used albuterol...as a rescue inhaler. It is NOT so the asthma attack can kill you.

They still recommend the use of Advair or Symbicort in people with COPD. And since I more resemble that patient profile than typical asthma, so I am sticking with my symbicort

I love to read articles though. SO off I go to see what else is being said about LABAs.

Asthma Drug Warning Strengthened
Robert Langreth, 03.03.06, 3:23 PM ET

GlaxoSmithKline

A strict new warning may impact sales of one of the world's top-selling asthma drugs.

GlaxoSmithKline (nyse: GSK - news - people ) said today it had reached an agreement to update its product label for its popular drug Advair with a strict new warning that advises doctors to limit the use of the drug only to patients who are not controlled on other asthma drugs, or have such severe cases.

The agreement comes in the wake of a giant 26,000 patient study, completed several years ago, that found a higher death rate in patients treated with salmeterol, one of the ingredients in Advair. The death data were already in the label in a black-box warning, but now the label also includes specific admonishments to doctors to restrict use of the powerful combination asthma drug to patients who really need it.

"almeterol] one of the active ingredients in ADVAIR DISKUS may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma controller medications...or whose disease severity clearly warrants initiation of treatments with two maintenance therapies," the new label says. Advair contains two medicines, an inhaled steroid to control inflammation, and salmeterol, which improves symptoms by expanding the airways. There also is a new label for Glaxo's Serevent, which just contains salmeterol.

GlaxoSmithKline "is pleased to have reached an agreement with [the] Food and Drug Administration on product labeling that is in the best interest of patients," the company said in a statement.

The agreement, however, appears to represent a partial victory for the FDA, which issued a public healthy advisory last November warning that use of the drug should be limited. At the time, GlaxoSmithKline said that it disagreed with the proposed label change.

Exactly how the new label will impact sales of Advair is not clear. Since the FDA's advisory last fall, Advair sales have continued to grow strongly. However, the new warning makes it official: doctors who use Advair as initial therapy in relatively mild cases would be using the drug off-label. Earlier this year, a GlaxoSmithKline executive insisted to analysts that any downside to a new label was limited since only 6% of Advair use is among patients not previously on asthma medication.

 

[Melissa75]

I am not sure if there has been a new study, but these drugs have gone before congress/FDA before. I'll paste a Forbes article below from 2006.
<br />
<br />When I asked my dr about it, he said that the risk is in people with asthma who are essentially confused and try to use a LABA the way they used albuterol...as a rescue inhaler. It is NOT so the asthma attack can kill you.
<br />
<br />They still recommend the use of Advair or Symbicort in people with COPD. And since I more resemble that patient profile than typical asthma, so I am sticking with my symbicort
<br />
<br />I love to read articles though. SO off I go to see what else is being said about LABAs.
<br />
<br />Asthma Drug Warning Strengthened
<br />Robert Langreth, 03.03.06, 3:23 PM ET
<br />
<br />GlaxoSmithKline
<br />
<br />A strict new warning may impact sales of one of the world's top-selling asthma drugs.
<br />
<br />GlaxoSmithKline (nyse: GSK - news - people ) said today it had reached an agreement to update its product label for its popular drug Advair with a strict new warning that advises doctors to limit the use of the drug only to patients who are not controlled on other asthma drugs, or have such severe cases.
<br />
<br />The agreement comes in the wake of a giant 26,000 patient study, completed several years ago, that found a higher death rate in patients treated with salmeterol, one of the ingredients in Advair. The death data were already in the label in a black-box warning, but now the label also includes specific admonishments to doctors to restrict use of the powerful combination asthma drug to patients who really need it.
<br />
<br />"almeterol] one of the active ingredients in ADVAIR DISKUS may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma controller medications...or whose disease severity clearly warrants initiation of treatments with two maintenance therapies," the new label says. Advair contains two medicines, an inhaled steroid to control inflammation, and salmeterol, which improves symptoms by expanding the airways. There also is a new label for Glaxo's Serevent, which just contains salmeterol.
<br />
<br />GlaxoSmithKline "is pleased to have reached an agreement with [the] Food and Drug Administration on product labeling that is in the best interest of patients," the company said in a statement.
<br />
<br />The agreement, however, appears to represent a partial victory for the FDA, which issued a public healthy advisory last November warning that use of the drug should be limited. At the time, GlaxoSmithKline said that it disagreed with the proposed label change.
<br />
<br />Exactly how the new label will impact sales of Advair is not clear. Since the FDA's advisory last fall, Advair sales have continued to grow strongly. However, the new warning makes it official: doctors who use Advair as initial therapy in relatively mild cases would be using the drug off-label. Earlier this year, a GlaxoSmithKline executive insisted to analysts that any downside to a new label was limited since only 6% of Advair use is among patients not previously on asthma medication.

 

[mamaScarlett]

So to get this straight (bc I'm on Advair continuously and some of these other ones sporadically)-
They're not saying that these drugs are dangerous-they are saying that relying on them ALONE is what can be dangerous...right...
Just making sure I understand this.
thanks for posting!

 

[mamaScarlett]

So to get this straight (bc I'm on Advair continuously and some of these other ones sporadically)-
They're not saying that these drugs are dangerous-they are saying that relying on them ALONE is what can be dangerous...right...
Just making sure I understand this.
thanks for posting!

 

[mamaScarlett]

So to get this straight (bc I'm on Advair continuously and some of these other ones sporadically)-
They're not saying that these drugs are dangerous-they are saying that relying on them ALONE is what can be dangerous...right...
Just making sure I understand this.
thanks for posting!

 

[mamaScarlett]

So to get this straight (bc I'm on Advair continuously and some of these other ones sporadically)-
They're not saying that these drugs are dangerous-they are saying that relying on them ALONE is what can be dangerous...right...
Just making sure I understand this.
thanks for posting!

 

[mamaScarlett]

So to get this straight (bc I'm on Advair continuously and some of these other ones sporadically)-
<br />They're not saying that these drugs are dangerous-they are saying that relying on them ALONE is what can be dangerous...right...
<br />Just making sure I understand this.
<br />thanks for posting!

 

[hmw]

<div class="FTQUOTE"><begin quote>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.</end quote></div>
I don't know about everyone else here, but for quite some time now I've been hearing about the risks of using these meds alone and the fact that they are NOT the same as long-acting inhalers in the commercials and/or other ads (and not as the mile-a-minute talk at the end (i.e. car dealership commercials no one can understand at the end, either- it's an obvious part of the commercial.) This doesn't sound new to me.

<div class="FTQUOTE"><begin quote>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.</end quote></div>

Using them for CF would also be different I'd think than in 'typical' asthma. The reasons for using them in CF are not likely to go improve to the point where they might go away (i.e. a large population of children outgrow childhood asthma or become controlled enough where the goal is less medication. The key to treating CF is staying on top of the symptoms via adequate, effective treatment. Upon finding something that works that we tolerate well, for most of us our minds don't turn to thoughts of 'ok, what can I do to be able to get off this medication?')

Christian~ yes, that is my understanding. And since using another 'asthma controlling med' is part of just about ALL of the treatment for those with cf even before ones of these meds is rx'ed I'd think we'd be covered when it comes to the precautions they are urging need to be taken to safely take these meds. Another point which I think is in our favor is that we are also fortunate to be cared for by drs who are real specialists in this field; many people with asthma probably rely on their gp's to handle their symptoms and may not have drs who have enough expertise on how they all work.

 

[hmw]

<div class="FTQUOTE"><begin quote>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.</end quote></div>
I don't know about everyone else here, but for quite some time now I've been hearing about the risks of using these meds alone and the fact that they are NOT the same as long-acting inhalers in the commercials and/or other ads (and not as the mile-a-minute talk at the end (i.e. car dealership commercials no one can understand at the end, either- it's an obvious part of the commercial.) This doesn't sound new to me.

<div class="FTQUOTE"><begin quote>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.</end quote></div>

Using them for CF would also be different I'd think than in 'typical' asthma. The reasons for using them in CF are not likely to go improve to the point where they might go away (i.e. a large population of children outgrow childhood asthma or become controlled enough where the goal is less medication. The key to treating CF is staying on top of the symptoms via adequate, effective treatment. Upon finding something that works that we tolerate well, for most of us our minds don't turn to thoughts of 'ok, what can I do to be able to get off this medication?')

Christian~ yes, that is my understanding. And since using another 'asthma controlling med' is part of just about ALL of the treatment for those with cf even before ones of these meds is rx'ed I'd think we'd be covered when it comes to the precautions they are urging need to be taken to safely take these meds. Another point which I think is in our favor is that we are also fortunate to be cared for by drs who are real specialists in this field; many people with asthma probably rely on their gp's to handle their symptoms and may not have drs who have enough expertise on how they all work.

 

[hmw]

<div class="FTQUOTE"><begin quote>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.</end quote></div>
I don't know about everyone else here, but for quite some time now I've been hearing about the risks of using these meds alone and the fact that they are NOT the same as long-acting inhalers in the commercials and/or other ads (and not as the mile-a-minute talk at the end (i.e. car dealership commercials no one can understand at the end, either- it's an obvious part of the commercial.) This doesn't sound new to me.

<div class="FTQUOTE"><begin quote>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.</end quote></div>

Using them for CF would also be different I'd think than in 'typical' asthma. The reasons for using them in CF are not likely to go improve to the point where they might go away (i.e. a large population of children outgrow childhood asthma or become controlled enough where the goal is less medication. The key to treating CF is staying on top of the symptoms via adequate, effective treatment. Upon finding something that works that we tolerate well, for most of us our minds don't turn to thoughts of 'ok, what can I do to be able to get off this medication?')

Christian~ yes, that is my understanding. And since using another 'asthma controlling med' is part of just about ALL of the treatment for those with cf even before ones of these meds is rx'ed I'd think we'd be covered when it comes to the precautions they are urging need to be taken to safely take these meds. Another point which I think is in our favor is that we are also fortunate to be cared for by drs who are real specialists in this field; many people with asthma probably rely on their gp's to handle their symptoms and may not have drs who have enough expertise on how they all work.

 

[hmw]

<div class="FTQUOTE"><begin quote>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.</end quote>
I don't know about everyone else here, but for quite some time now I've been hearing about the risks of using these meds alone and the fact that they are NOT the same as long-acting inhalers in the commercials and/or other ads (and not as the mile-a-minute talk at the end (i.e. car dealership commercials no one can understand at the end, either- it's an obvious part of the commercial.) This doesn't sound new to me.

<div class="FTQUOTE"><begin quote>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.</end quote>

Using them for CF would also be different I'd think than in 'typical' asthma. The reasons for using them in CF are not likely to go improve to the point where they might go away (i.e. a large population of children outgrow childhood asthma or become controlled enough where the goal is less medication. The key to treating CF is staying on top of the symptoms via adequate, effective treatment. Upon finding something that works that we tolerate well, for most of us our minds don't turn to thoughts of 'ok, what can I do to be able to get off this medication?')

Christian~ yes, that is my understanding. And since using another 'asthma controlling med' is part of just about ALL of the treatment for those with cf even before ones of these meds is rx'ed I'd think we'd be covered when it comes to the precautions they are urging need to be taken to safely take these meds. Another point which I think is in our favor is that we are also fortunate to be cared for by drs who are real specialists in this field; many people with asthma probably rely on their gp's to handle their symptoms and may not have drs who have enough expertise on how they all work.

 

[hmw]

<div class="FTQUOTE"><begin quote>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.</end quote>
<br />I don't know about everyone else here, but for quite some time now I've been hearing about the risks of using these meds alone and the fact that they are NOT the same as long-acting inhalers in the commercials and/or other ads (and not as the mile-a-minute talk at the end (i.e. car dealership commercials no one can understand at the end, either- it's an obvious part of the commercial.) This doesn't sound new to me.
<br />
<br /><div class="FTQUOTE"><begin quote>The FDA will now require that the product labels reflect the following:
<br />
<br />.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;
<br />.LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications;
<br />.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.</end quote>
<br />
<br />Using them for CF would also be different I'd think than in 'typical' asthma. The reasons for using them in CF are not likely to go improve to the point where they might go away (i.e. a large population of children outgrow childhood asthma or become controlled enough where the goal is less medication. The key to treating CF is staying on top of the symptoms via adequate, effective treatment. Upon finding something that works that we tolerate well, for most of us our minds don't turn to thoughts of 'ok, what can I do to be able to get off this medication?')
<br />
<br />Christian~ yes, that is my understanding. And since using another 'asthma controlling med' is part of just about ALL of the treatment for those with cf even before ones of these meds is rx'ed I'd think we'd be covered when it comes to the precautions they are urging need to be taken to safely take these meds. Another point which I think is in our favor is that we are also fortunate to be cared for by drs who are real specialists in this field; many people with asthma probably rely on their gp's to handle their symptoms and may not have drs who have enough expertise on how they all work.