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Foradil Aerolizer FDA Alerts

The FDA Alert(s) below may be specifically about Foradil Aerolizer or relate to a group or class of drugs which include Foradil Aerolizer (formoterol).

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. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for formoterol

Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements

Apr 15, 2011

Audience: Asthma management healthcare professionals, patients

[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

Jun 3, 2010

Audience: Asthma management healthcare professionals, patients

[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

Feb 18, 2010

Audience: Asthma management healthcare professionals, patients

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]

    

Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) Capsules

Feb 29, 2008

Audience: Pulmonologists, respiratory therapists, pharmacists, other healthcare professionals, patients

[Posted 02/29/2008] FDA informed healthcare professionals and consumers of the correct way to use Spiriva and Foradil inhalation powder capsules. FDA and the American Association of Poison Control Center’s (AAPCC) National Poison Data System have received many reports of patients swallowing Spiriva and Foradil capsules rather than placing the capsules in the inhalation devices. Both products are to be used in the HandiHaler (Spiriva) and Aerolizer (Foradil) devices to deliver the medicine to the lungs to improve breathing in patients with asthma, and in individuals affected by chronic obstructive lung disease and bronchitis. Both products will not treat a patient's breathing condition if the contents of a capsule are swallowed rather than inhaled. Healthcare professionals should discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer.

Foradil Aerolizer (formoterol fumarate inhalation powder)

Nov 18, 2005

Audience: Pulmonologists, other healthcare professionals and consumers

[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.

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