Audience: Asthma management health care professionals, patients
February 18, 2010 — The FDA notified health care professionals that, due to safety concerns, the FDA is requiring a risk management strategy (REMS) and class-labeling changes for all LABAs. These changes are based on the FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations and deaths in some patients using LABAs for the treatment of asthma.
The drugs involved include the single agent products Serevent and Foradil and combination medications Advair and Symbicort that also contain inhaled corticosteroids.
The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate health care professionals about the appropriate use of LABAs.
Health care professionals are reminded that to ensure the safe use of these products:
- Single-ingredient 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 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 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.
The FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. The FDA believes the safety measures recommended will improve the safe use of these drugs.
February 18, 2010 — drug safety communication
February 18, 2010 — questions and answers: long-acting beta agonists
February 18, 2010 — press release
