FDA Updates U.S. Product Labels for LABA-Containing Medications Including AstraZeneca's Symbicort
WILMINGTON, Del., June 2 /PRNewswire-FirstCall/ -- Today, the
U.S. Food and Drug Administration (FDA) released final label
revisions for respiratory medications that contain an active
ingredient known as a long-acting beta-agonist (LABA). This follows
the FDA communication on 18 February 2010 requesting all
manufacturers of LABA-containing medications to undertake
The FDA made label revisions to both single ingredient and
combination LABA-containing medications. For the treatment of
asthma, single ingredient LABAs should only be used with an asthma
controller medication such as an inhaled corticosteroid (ICS), they
should not be used alone. SYMBICORT® (budesonide/formoterol
fumarate dihydrate) is an asthma combination medication that
contains both an ICS (budesonide) and a LABA (formoterol).
The updated label for combination asthma medications, including
SYMBICORT, provides guidance on how these products should be
prescribed to treat asthma, including:
-- SYMBICORT should only be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. -- Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid.
In addition, the Boxed Warning, and other relevant sections of
the label, have been revised to inform healthcare professionals and
patients that LABAs, when used as single ingredient products,
increase the risk of asthma-related death based on a large
placebo-controlled study with salmeterol (a single ingredient LABA
product). FDA considers this risk to be a class effect of all
LABAs, including formoterol, one of the components of SYMBICORT.
Currently available data are inadequate to determine whether
concurrent use of inhaled corticosteroids or other long-term asthma
control drugs mitigates the increased risk of asthma-related death
"AstraZeneca is confident in the positive benefit-risk profile
of SYMBICORT in asthma. Combination therapies, such as SYMBICORT,
continue to play a critical role in helping appropriate patients
control asthma symptoms," said Dr. Cathy Bonuccelli, Vice
President, Clinical Respiratory & Inflammation, AstraZeneca.
"Regular assessments of patients' asthma control by their
physicians is important for ensuring that they are on the
appropriate therapy based on their individual treatment
In SYMBICORT clinical studies, AstraZeneca has shown that the
combination of budesonide and formoterol provides clear benefits to
appropriate patients with asthma, such as improvement in asthma
measures of control and quality of life.
Patients who are currently taking SYMBICORT should continue
their prescribed medication, and talk to their doctor regarding any
questions they may have about their treatment.
The updated label only impacts the asthma indication for
SYMBICORT and does not pertain to the other approved use of
SYMBICORT for chronic obstructive pulmonary disease (COPD).
Important Safety Information, including boxed WARNING WARNING: ASTHMA RELATED DEATH
Long-acting beta2-adrenergic agonists (LABA), such as formoterol
one of the active ingredients in SYMBICORT, increase the risk of
asthma-related death. Data from a large placebo-controlled U.S.
study that compared the safety of another long-acting beta2-
adrenergic agonist (salmeterol) or placebo added to usual asthma
therapy showed an increase in asthma-related deaths in patients
receiving salmeterol. This finding with salmeterol is considered a
class effect of the LABA, including formoterol. Currently available
data are inadequate to determine whether concurrent use of inhaled
corticosteroids or other long-term asthma control drugs mitigates
the increased risk of asthma-related death from LABA. Available
data from controlled clinical trials suggest that LABA increase the
risk of asthma-related hospitalization in pediatric and adolescent
patients. Therefore, when treating patients with asthma, SYMBICORT
should only be used for patients not adequately controlled on a
long-term asthma control medication, such as an inhaled
corticosteroid or whose disease severity clearly warrants
initiation of treatment with both an inhaled corticosteroid and
LABA. Once asthma control is achieved and maintained, assess the
patient at regular intervals and step down therapy (e.g.,
discontinue SYMBICORT) if possible without loss of asthma control
and maintain the patient on a long-term asthma control medication,
such as an inhaled corticosteroid. Do not use SYMBICORT for
patients whose asthma is adequately controlled on low or medium
dose inhaled corticosteroids.
SYMBICORT is NOT a rescue medication and does NOT replace
fast-acting inhalers to treat acute symptoms.
Particular care is needed for patients who are transferred from
systemically active corticosteroids to inhaled corticosteroids.
Deaths due to adrenal insufficiency have occurred in asthmatic
patients during and after transfer from systemic corticosteroids to
less systemically available inhaled corticosteroids.
Patients who are receiving SYMBICORT should not use additional
formoterol or other long-acting inhaled beta2-agonists for any
Caution should be exercised when considering the
coadministration of SYMBICORT with long-term ketoconazole and other
known potent CYP3A4 inhibitors.
Excessive beta-adrenergic stimulation has been associated with
central nervous system and cardiovascular effects. SYMBICORT, like
all products containing sympathomimetic amines, should be used with
caution in patients with cardiovascular disorders, especially
coronary insufficiency, cardiac arrhythmias, and
Long-term use of orally inhaled corticosteroids, such as
budesonide, a component of SYMBICORT, may affect normal bone
metabolism resulting in a loss of bone mineral density.
Glaucoma, increased intraocular pressure, and cataracts have
been reported following the inhaled administration of
corticosteroids, including budesonide, a component of
SYMBICORT should be administered with caution to patients being
treated with MAO inhibitors or tricyclic antidepressants, or within
2 weeks of discontinuation of such agents.
Additional Information Specific to Asthma
The most common adverse events greater than or equal to 5%
reported in clinical trials included nasopharyngitis, headache,
upper respiratory tract infection, pharyngolaryngeal pain,
sinusitis, and stomach discomfort.
Additional Information Specific to COPD
For patients with COPD, the approved dosage of SYMBICORT is
160/4.5 mcg, 2 inhalations twice daily.
The most common adverse events greater than or equal to 3%
reported in COPD clinical trials included nasopharyngitis, oral
candidiasis, bronchitis, sinusitis, and upper respiratory tract
Lower respiratory tract infections, including pneumonia, have
been reported following the inhaled administration of
In 2 placebo-controlled SYMBICORT COPD clinical studies,
pneumonia did not occur with greater incidence in the SYMBICORT
160/4.5 group, compared with placebo, while the incidence of lung
infections other than pneumonia (eg, bronchitis) was higher for
SYMBICORT than placebo.
SYMBICORT is indicated for the treatment of asthma in patients
12 years of age and older.
SYMBICORT 160/4.5 mcg is also indicated for the maintenance
treatment of airflow obstruction in patients with chronic
obstructive pulmonary disease (COPD), including chronic bronchitis
and emphysema. For patients with COPD, the approved dosage of
SYMBICORT is 160/4.5 mcg two inhalations twice daily. SYMBICORT
does not replace fast-acting inhalers and should not be used to
treat acute symptoms of COPD or asthma. SYMBICORT should not be
initiated in patients during rapidly deteriorating or potentially
life-threatening episodes of COPD.
Please see full Prescribing Information, including boxed
WARNING, and visit www.MySYMBICORT.com.
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Posted: June 2010