FDA updates US product labels for LABA-containing medications including AstraZeneca’s SYMBICORT

Wednesday, 2 June 2010

Today, the US 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 class-labelling changes.

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 from LABA.

“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 needs.”

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).

To view the FDA communication, visit the following FDA Web site link: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213836.htm


About Symbicort
In the US, SYMBICORT is indicated for the treatment of asthma in patients 12 years of age and older.

SYMBICORT is approved in more than 100 countries and is available in two different inhalers, SYMBICORT TURBUHALER and SYMBICORT pMDI.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines.  As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009.  For more information please visit: www.astrazeneca.com


Media Enquiries:
Neil McCrae +44 20 7304 5045  (24 hours)
Chris Sampson +44 20 7304 5130  (24 hours)
Sarah Lindgreen +44 20 7304 5033  (24 hours)
Abigail Baron +44 20 7304 5034  (24 hours)

Investor Enquiries UK:
Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032
Karl Hård +44 207 304 5322 mob: +44 7789 654364
Clive Morris +44 207 304 5084 mob: +44 7710 031012

Investor Enquiries US:
Ed Seage +1 302 886 4065 mob: +1 302 373 1361
Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043


  • Corporate and financial
  • Science