After the Food and Drug Administration (FDA) approves a product and it is on the market, FDA continues to monitor unexpected and undesirable side effects (adverse events) of that product.
Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, by fax, or by phone.
Regular Mail: Use...
LABAs should never be used alone in the treatment of asthma in children or adults
when LABAs are needed, they be used for the shortest time possible to achieve asthma control. They are then to be discontinued, if possible, to limit the long-term use
FDA's actions are based on agency analyses of studies showing an increased risk of severe worsening of asthma symptoms, leading to hospitalization in pediatric and adult patients—as well as death in some patients—using the treatment for asthma.
LABAs are available as single ingredient products, or in combination with a corticosteroid medication. (The reason that some LABAs are offered as single-ingredient products is that not all asthma controller medicines are able to be made into a combination product.)
The drugs affected by FDA's announcement include
the single-ingredient products Serevent (generic name: salmeterol) and Foradil (formoterol)
the combination medications Advair (salmeterol and fluticasone) and Symbicort (formoterol and budesonide)
How LABAs Work
LABAs help people with asthma or a lung condition called chronic obstructive pulmonary disease (COPD) breathe easier. They are also used for exercise-induced bronchospasm, which is asthma that is triggered by vigorous physical activity.
Taken through the mouth using an inhaler or a nebulizer, LABAs relax the muscles of the airways to allow more air to flow into and out of the lungs. Their effects last for at least 12 hours.
FDA's recommendations only apply to the use of LABAs in the treatment of asthma.
“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 serious asthma exacerbations and death,” says Badrul Chowdhury, M.D., director of FDA's Division of Pulmonary and Allergy Products.
“The risks of hospitalization and poor outcomes are of particular concern for children," says Dianne Murphy, director of FDA’s Office of Pediatric Therapeutics. "Parents need to know that their child should not be on a LABA alone.”
In addition to following the recommendations issued on Feb. 18, FDA advises patients to
know that LABAs do not relieve sudden-onset asthma symptoms. Patients should always have a rescue inhaler, such as an albuterol inhaler, to treat sudden-onset asthma symptoms
know that, if they need a LABA plus an asthma controller medication that is not available as a combination product, they should work with their health care professionals to ensure that each individual medication is taken correctly
read the Medication Guide included in each LABA
talk with their health care professionals to learn the warning signs of worsening asthma, and to discuss any questions they have about the use of LABAs