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Long Acting Asthma Medication: FDA Committee Recommendation December 10-11, 2008

Background

On December 10 and 11, 2008, the FDA convened three committees of experts to discuss a risk benefit assessment of long acting bronchodilators.

Two of the brands (Serevant® and Foradil®) are long acting beta agonists (LABAs), and two (Advair® and Symbicort®) combine LABAs with inhaled corticosteroids.

The panel heard presentations from FDA staff and sponsors, reviewed a meta-analysis of clinical studies, and heard public testimony from interested parties including specialists representing major medical associations, patients, and researchers. The panel members discussed the benefits and risks of LABAs for various age groups. The panelists also discussed recommendations on labeling changes, risk mitigation strategies, and suggestions for further studies.

The Panel Voted

The panel voted on questions presented to them as to each of the four brands: do the benefits of each product outweigh the risks for the maintenance treatment of asthma in patients not adequately controlled on other asthma controller medications or whose disease severity clearly warrants initiation of treatment with two maintenance therapies?

The Outcome

THE PANEL VOTED THAT THE BENEFITS DO NOT OUTWEIGH THE RISKS of Serevent® or Foradil® for the treatment of asthma.

However, THE PANEL VOTED THAT THE BENEFITS DO OUTWEIGH THE RISKS of Advair® and Symbicort® in the treatment of asthma.

The vote was nearly unanimous related to Advair® and Symbicort® in adults and adolescents. However, the vote on Advair® in children was split with no majority (13 voting ‘yes’ and 11 voting ‘no’ with 3 voting to abstain).

What Happens Now

The recommendations will be forwarded to the FDA, which may implement them. Typically, the FDA follows the recommendations of its advisory panels.

What You Need to Know

  1. The safety of Serevant®, Foradil®, Advair® and Symbicort® was not determined by the panel. You may have heard news reports that certain asthma medications are now considered unsafe.

    The panel recommended that the benefits of certain medications do not outweigh their risks for treating asthma unless they are used in combination with inhaled corticosteroids. Those medications are sold under the brand names Serevant® and Foradil®.

    This does not mean that the FDA has declared that Serevant® and Foradil® are unsafe, nor does it mean that patients should stop taking them.

  2. The advisory panel declined to make the same recommendation for Advair® and Symbicort® bronchodilators because both combine long acting beta agonists with inhaled corticosteroids.

    The group of experts divided on whether these medications are worth the risk for asthma patients who are adolescents or children. However, the panel heard compelling evidence from doctors who treat asthma and patients to keep this drug available because of its lifesaving and quality of life benefits.

  3. The FDA will now consider these recommendations and may choose to follow the advisory committees’ recommendation to withdraw the approval of Serevent and Foradil® for asthma, but retain approval of Advair® and Symbicort® for asthma indications.

    It could choose to implement some, all or none of their recommendations, but typically, the FDA follows the recommendations of its advisory committees.

  4. The American Academy of Asthma, Allergy and Immunology, the American Academy of Pediatrics, American Thoracic Society, American College of Allergy, Asthma and Immunology and the National Medical Association all supported the continued use of LABAs as recommended by the NAEPP Asthma Guidelines.
  5. In advance of this two-day meeting, the FDA staff submitted diverging recommendations. The Office of Surveillance and Epidemiology was not persuaded that LABAs offer substantial benefits and saw substantial risks.

    However, the Division of Pulmonary and Allergy Products urged keeping these products available for asthma patients with the current labeling and Black-Box warning.

  6. During the meeting, members of the committees raised issues about appropriate use and patient adherence to this class of medications. Some shared anecdotes about patient under-use, and physicians who prescribe Advair® to treat wheezing associated with bronchitis, not asthma.

    Others discussed prescribing Advair® as a first level treatment for asthma rather than for control of symptoms that are not controlled by other medications.

  7. Labeling: Many concluded that the labels should take care of this issue if prescribers follow them diligently. Some suggested that sponsor advertising is driving patients to Advair® as a first line of treatment because they see fewer ads for Flovent®.

    Patients can help promote safety and efficacy by asking their prescribers if this class of medicines is right for them, given their level of asthma symptom control.

  8. Most of the panelists said that they want to see additional studies and clinical data, particularly on risk factors in children, adolescents, African-Americans, and women.
  9. Over the past several years, AAFA has testified at FDA meetings, reviewed background material, and had patients testify at meetings.

    Last month, we presented a statement to the FDA on the issue of benefits and risks for this class of drugs.

Subscribe to our E-mail List for Action Alerts & E-Newsletters

We are issuing an Action Alert to our email list, and we will continue to reach out to the asthma specialist societies to collaborate on recommendations that support patient’s interests.

AAFA also will continue to work with government officials, pharmaceutical sponsors, and physicians to promote research and patient education to assure that medications on the market are safe and beneficial to patients.

Actions Patients Can Take

  1. If you are taking any of these drugs (Serevant®, Foradil®, Advair®, and Symbicort®), please take note.

    Do not panic! Do not stop taking these medications as prescribed by your doctor. You should see your doctor and discuss your options.

    Make sure that you are taking your medications as prescribed. These medications are not intended for patients whose asthma is well-controlled on other medications. If you are in that category, and are taking one of the four medications, talk to your doctor immediately.

  2. Let AAFA know how these medications help you, by submitting a comment directly to us, email Betsy Stoller, Advocacy and Outreach Coordinator at [email protected]. We need to hear about the benefits of these medications from real patients with asthma.