Safety Alerts & Recalls

What does this mean?

This safety concern of an increased risk of severe exacerbation of asthma symptoms with LABAs has been known for some time and these products already contain a Black Box Warning relating to this risk. The FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medications such as an inhaled corticosteroid. That said, this alert is a reminder to ALL patients using LABAs to keep your doctor's appointments and regularly review your lung and breathing symptoms and your treatment plan with your doctor.

If you have asthma and use a LABA (sold as Serevent, Foradil, Brovana) or a LABA in combination with an inhaled corticosteroid (sold as Advair, Symbicort), please review the following suggestions from the FDA:

1) Long-Acting Beta Agonists (LABAs) do not relieve sudden-onset asthma symptoms. Patients should always have a rescue inhaler, such as an albuterol inhaler, to treat sudden onset asthma symptoms.

2) LABAs must never be taken alone for the treatment of asthma. Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both ingredients, to ensure compliance.

3) 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. However, do not stop your asthma inhaler medications without first talking with your doctor.

4) Patients who need a LABA plus an asthma controller medication that is not available as a combination product should work with their healthcare professionals to ensure that each individual medication is taken correctly.

5) Patients should read the Medication Guide for LABAs.

6) Patients should talk with their healthcare professional to learn the warning signs of worsening asthma and how to manage these symptoms.

If you have any questions about the use of LABAs for asthma, COPD or other lung conditions, please follow up directly with your doctor or other healthcare professional.

New Safety Requirements for Long-acting Inhaled Asthma Medications Called Long-Acting Beta-Agonists (LABAs)

The U.S. Food and Drug Administration (FDA) today announced that drugs in the class of long-acting beta agonists (LABAs) including salmeterol (Serevent), formoterol (Foradil), and aformoterol (Brovana) should never be used alone in the treatment of asthma in children or adults. LABAs should only be used in combination with an asthma controller medication such as an inhaled corticosteroid including beclomethasone (Beclovent, QVAR), budesonide (Pulmicort Flexhaler, Pulmicort Respules), ciclesonide (Alvesco), flunisolide (AeroBid, Aerospan), fluticasone (Flovent), mometasone (Asmanex Twisthaler), and triamcinolone, (Azmacort). LABAs and inhaled corticosteroids are also available combined in a single inhaler, sold under the names Advair (salmeterol and fluticasone) and Symbicort (formoterol and budesonide).

Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to promote the safe use of these medications. These changes are based on the FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations as well as death in some pediatric and adult patients.

LABAs are inhaled medications approved for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The new recommendations only apply to the use of LABAs ALONE in patients with asthma: salmeterol (Serevent), formoterol (Foradil), and aformoterol (Brovana).

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Source: FDA
Publication Date: 2010-02-18
Last Updated: 2010-06-03

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