FDA Changing Safety Statements For LABAs

While there has been a black box warning for long acting beta agonists or LABAs for some time, the FDA stated in a press release this week that LABAs "should never be used alone in the treatment of asthma in children or adults." Companies will be required to change warning information in addition to taking steps to attempt to decrease use.

The FDA has based its decision, which applies to both single agent LABAs like Serevent and Foradil and combination medications like Advair and Symbicort containing inhaled corticosteroids, on research demonstrating LABA use increases risk of severe asthma symptoms and may result in hospitalization and death in some patients with asthma.

According to the press release, the FDA will now require the following be included in product labeling:

• The use of LABAs is contraindicated without the use of an asthma controller medication such as inhaled corticosteroid. Single-agent LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
• 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. Patients should then be maintained on an asthma controller medication.
• Pediatric and adolescent patients who require a LABA in addition to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA to ensure compliance with both medications.

Badrul Chowdhury, M.D., director of the Division of Pulmonary and Allergy Products in the FDA's Center for Drug Evaluation and Research stated in the press release that "although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death."

The FDA will hold a public advisory committee meeting in March 2010 to gain input on further studies to evaluate the safety of LABAs.

You can see the full FDA press release on the FDA website.