New FDA safety requirements for Long-Acting Beta-Agonists (LABAs): never take LABAs alone, use only for shortest time

Update from Thorax 2012: Clearing the air: LABA/ICS reduce asthma hospitalizations, not associated with life-threatening events and deaths http://goo.gl/TesRp

- The use of LABAs is contraindicated without the use of an asthma controller medication such as an inhaled corticosteroid. Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone. LABAs must never be taken alone for the treatment of asthma. Long-Acting Beta Agonists (LABAs) should not be started in patients with acutely deteriorating asthma.

Currently, LABAs are approved as single-ingredient products (Serevent and Foradil) and as an ingredient in combination products containing inhaled corticosteroids (Advair and Symbicort) for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

- LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.

- LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved.

- 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 compliance with both medications.


Advair Diskus (left), Symbicort Turbuhaler (right). Image sources: Wikipedia, public domain.

The LABAs labels must state that:

- asthma patients must not take LABAs on a long-term basis unless their condition cannot be adequately controlled with other medications such as inhaled corticosteroids.

- the LABAs should never be used alone in the treatment of asthma in adults or children.

95% of asthma patients using an LABA receive it in combination with a corticosteroid in a single inhaled product such as Advair Diskus, Advair HFA, or Symbicort.

"We think the greater public health benefit is to reduce the use of LABAs, but keep them available for patients who really need them," said John Jenkins, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research during the news conference. "There is still a benefit to these drugs for patients who aren't absolutely controlled on asthma-control medications."

Specific Label Changes for Long-Acting Beta-Agonists (LABAs)

1. Contraindicate the use of LABAs for asthma in patients of all ages without concomitant use of an asthma-controller medication such as an inhaled corticosteroid.

2. Stop use of the LABA, if possible, once asthma control is achieved and maintain the use of an asthma-controller medication, such as an inhaled corticosteroid.

3. Recommend against LABA use in patients whose asthma is adequately controlled with a low- or medium-dose inhaled corticosteroid.

4. Recommend that a fixed-dose combination product containing a LABA and an inhaled corticosteroid be used to ensure compliance with concomitant therapy in pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid.

The risk of serious asthma exacerbations and asthma-related death is not unique to LABAs. It has been known for over 50 years that SABAs can worsen asthma and cause asthma-related death. The FDA will require manufacturers of LABAs to conduct large clinical trials that evaluate this risk by comparing inhaled corticosteroids plus LABAs with inhaled corticosteroids alone.

Related:

The Science Business Blog - Forbes.com, 2010.
Risk of asthma exacerbations: Relative to SABA-only therapy, LABA use is associated with a lower risk of ED visit http://goo.gl/4sDc9

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