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FDA: New Warnings for Beta- Agonists (Advair and others)

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The regulatory agency says new warnings are needed on long-acting beta-agonists, including GSK?s Serevent and Advair, because the medication could result in severe asthma symptoms that lead to hospitalizations in children and adults or even result in death.

The FDA believes that when LABAs are used according to the recommendations outlined above and in the approved drug labels, the benefits of LABAs in improving asthma symptoms outweigh their risks of increasing severe asthma exacerbations and deaths from asthma.

The new recommendations in the updated labels state:

* Use of a Long Acting Beta Agonist (LABA) alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (absolutely advised against) in the treatment of asthma.
* LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
* LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid.
* Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.
* Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure adherence with both medications.

Source

Full post as published by A Georgia Lawyer on June 08, 2010 (boomark / email).