Serevent Diskus FDA Alerts
The FDA Alerts below may be specifically about Serevent Diskus or relate to a group or class of drugs which include Serevent Diskus.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Serevent Diskus
Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
[UPDATED 04-15-2011] To further evaluate the safety of Long-Acting Beta-Agonists (LABAs) when used in combination with inhaled corticosteroids for the treatment of asthma, the FDA is requiring the manufacturers of LABAs to conduct five randomized, double-blind, controlled clinical trials comparing the addition of LABAs to inhaled corticosteroids versus inhaled corticosteroids alone. The clinical trials will begin in 2011 and FDA expects to receive results in 2017.
[UPDATED 06/03/2010] Drug labels now contain updated recommendations.
[Posted 02/18/2010] FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all LABAs. The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma.
Healthcare professionals are reminded that to ensure the safe use of these products:
- Single-ingredient 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 the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.
FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs.
[04/15/2011 - Drug Safety Communication - FDA]
[06/03/2010 - Drug Safety Communication - FDA]
[02/18/2010 - Drug Safety Communication - FDA]
[02/18/2010 - Questions and Answers: Long-Acting Beta Agonists - FDA]
[02/18/2010 - Press Release - FDA]
Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
[UPDATED 06/03/2010] Drug labels now contain updated recommendations.
[Posted 02/18/2010] FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all LABAs. The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma.
Healthcare professionals are reminded that to ensure the safe use of these products:
- Single-ingredient 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 the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.
FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs.
[06/03/2010 - Drug Safety Communication - FDA]
[02/18/2010 - Drug Safety Communication - FDA]
[02/18/2010 - Questions and Answers: Long-Acting Beta Agonists - FDA]
[02/18/2010 - Press Release - FDA]
Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all LABAs. The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma.
Healthcare professionals are reminded that to ensure the safe use of these products:
- Single-ingredient 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 the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.
FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs.
[02/18/2010 - Drug Safety Communication - FDA]
[02/18/2010 - Questions and Answers: Long-Acting Beta Agonists - FDA]
[02/18/2010 - Press Release - FDA]
Serevent Diskus (salmeterol xinafoate inhalation powder)
[Posted 11/18/2005] FDA notified manufacturers of Advair Diskus, Foradil Aerolizer, and Serevent Diskus to update their existing product labels with new warnings and a Medication Guide for patients to alert health care professionals and patients that these medicines may increase the chance of severe asthma episodes, and death when those episodes occur. All of these products contain long-acting beta2-adrenergic agonists (LABA). Even though LABAs decrease the frequency of asthma episodes, these medicines may make asthma episodes more severe when they occur. A Medication Guide with information about these risks will be given to patients when a prescription for a LABA is filled or refilled.Serevent Inhalation Aerosol and Diskus (salmeterol xinafoate)
The FDA announced the addition of new safety information and warnings to the labeling for drug products that contain salmeterol, a long-acting bronchodilator used to treat asthma and chronic obstructive pulmonary disease (COPD). The new labeling includes a boxed warning about a small, but significant, increased risk of life-threatening asthma episodes or asthma-related deaths observed in patients taking salmeterol in a recently completed large U.S. safety study.[August 2003 Letter - GlaxoSmithKline]
[August 14, 2003 Talk Paper - FDA]
[August 2003 Revised label, Serevent - GlaxoSmithKline]
[August 2003 Revised label, Serevent Diskus - GlaxoSmithKline]
[August 2003 Revised label, Advair Diskus - GlaxoSmithKline]
Serevent (salmeterol xinafoate)
GlaxoSmithKline notified healthcare professionals of important new safety information on use of Serevent in patients with asthma. Recent findings from an interim analysis of a large Serevent safety study have prompted further review of the potential association between Serevent and rare, but potentially serious, respiratory adverse events.[January 23, 2003 Letter - FDA] PDF Format
[January 23, 2003 Talk Paper - FDA]
