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BLACK BOX WARNING ISSUED FOR LONG ACTING BRONCHODILATORS.
The U.S. Food and Drug Administration (FDA) has issued a public
health advisory to highlight to the public certain risks
associated with the use of long acting bronchodilators (LABAs)
such as Serevent©, Advair© and Foradil©. While LABAs do decrease
the number of asthma episodes, these medicines may increase the
chances of a severe asthma episode when they do occur. Please
discuss any concerns you may have with your physician. The
public health advisory can be found at
http://www.fda.gove/cder/drug/advisory/LABA.htm
Rare (sometimes fatal) asthma-related problems have occurred in
patients being treated for asthma with long-acting
bronchodilators (LABAs). In patients taking long acting
bronchodilators for 28 weeks, there were 13 deaths in 13, 16
patients (0.08% or 8/10,000) versus the placebo group with 3
deaths in 13,179 (0.03% or 3/10,000). The majority of these
deaths occurred in African-American patients. The exact etiology
of this observation in African-Americans remains unknown. Review
of the study could not establish a direct casual relationship
associated with use of these drugs per se, but did raise a
concern regarding the importance of using these drugs strictly
as prescribed. This is not unique to long-acting
bronchodilators. Asthma can also worsen when overusing rescue
inhalers such as albuterol.
It is important to recognize that there are a very small number
of patients who may notice an increase in their asthma symptoms
when taking a long-acting bronchodilator. This generally occurs
in the first weeks of treatment and resolves when the medication
is stopped.
The FDA has requested that a "black box" warning be placed on
these medications to alert the public about these findings and
to encourage patients to discuss the proper use of these drugs
with their doctor. It is worth noting that the FDA Advisory
Committee affirmed that these drugs should remain on the market
because, in general, their benefits are felt to far outweigh the
risks.
Denver Allergy and Asthma Associates, P.C. follows the FDA
guidelines for LABAs which include the following suggestions:
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LABAs should not be the first medicine used to treat asthma.
LABAs should be added if other medications are not
controlling asthma.
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Use long-acting bronchodilators in conjunction with an
inhaled steroid. LABAs should never be used alone as a
controller medication for asthma.
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Patients who are currently taking LABAs should not
discontinue their treatment without first consulting a
physician. Abruptly stopping medications may result in acute
loss of asthma control, which may be life-threatening.
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LABAs should not be used to treat acute symptoms.
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Patients on LABAs must also have a short-acting
bronchodilator (e.g., albuterol) for treating acute
symptoms.
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Patients need to recognize that increased need for using a
short-acting bronchodilator is a sign of deteriorating
asthma (e.g., use of albuterol more than four times in 24
hours).
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Patients experiencing increased asthma should seek medical
attention promptly.
DO NOT STOP your asthma medication without consulting your
physician. Untreated asthma poses a much greater risk than using
long-acting bronchodilators. We encourage you to discuss any
concerns that you may have regarding the use of LABAs with your
Denver Allergy and Asthma Associates provider.
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