The U.S. Food and Drug Administration announced that it has required makers of certain asthma medications – so-called long acting beta-agonists (LABAs) such as GlaxoSmithKline's Advair and AstraZeneca's Symbicort – due to safety concerns when the drugs are used by themselves to treat the condition.
In February, the FDA said the long-acting beta agonists could exacerbate patients' asthma and result in hospitalization or even death. At the time the federal drug agency said it was requiring makers ot the medications revise their labels to reflect the concerns.
On Wedneday June 2 the FDA released the following label recommendations:
Use of a 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.
LABAs relax the muscles of airways to allow easier breathing when taken using an inhaler or nebulizer.
The agency noted that the safety issues were related to the medications' use to threat asthma, not Chronic obstructive pulmonary disease (COPD), another condition the drugs are used for. And the FDA reiterated that when used according to the recommendations it has outlined that the benefits of LABAs outweigh the risks.
Also on Wednesday the FDA released the following information for patients using the medications:
Long-Acting Beta Agonists (LABAs) do not relieve sudden-onset asthma symptoms. You should always have a rescue inhaler, such as an albuterol inhaler, to treat sudden onset asthma symptoms.
LABAs must never be taken alone for the treatment of asthma.
If you need a LABA plus a long-term asthma control medication that is not available as a combination product, you should work with your healthcare professional to ensure that each medication is taken correctly.
You should read the Medication Guide for LABAs and talk to your healthcare professional about any questions you may have about the use of LABAs.
In February, the FDA said its analysis of studies showed use of the drugs such as Advair, Brovana, Foradil, Perforomist, Serevent, and Symbicort increased the risk of worsening asthma symptoms that could lead to hospitalization, and in some cases death.