The Food and Drug Administration (FDA) has issued new requirements for the safe use of long-acting [beta]-agonist (LABA) in-halers in patients with asthma. The new safety requirements follow the FDA's conclusion, based on several studies, that LABAs increase the risk of severe asthma exacerbation, requiring hospitalization in pediatric and adult patients and increasing the risk of death.
LABAs work on specific receptors that induce bronchial dilation and are considered maintenance drugs for asthma. Included in this category are salmeterol (Serevent Diskus) and formoterol (Foradil Aerolizer), which are approved for use in treating asthma, chronic obstructive pulmonary disease (COPD), and exercise-induced bronchospasm. For some time LABAs have been recommended for use only in uncontrolled asthma.
The FDA's conclusion was based on two large, controlled clinical trials in patients ages 12 and older (the Salmeterol Multicenter Asthma Research Trial [SMART], a placebo-controlled trial with 26,355 patients, and the Salmeterol Nationwide Surveillance study, a double-blind study with 25,180 patients) and on the agency's own meta-analysis of 110 studies covering a total of 60,954 asthma patients. SMART concluded that black patients were at highest risk for asthma exacerbation or death; white patients had the next highest risk (no asthma-related deaths were reported in the trial among those listed as Hispanic, Asian, or "other"). The meta-analysis suggests that the greatest risk of asthma-related hospitalization resulting from use of a LABA is in children ages four to 11 years.
The FDA continues to believe that the benefit of adding a LABA to treat uncontrollable asthma in some patients outweighs the risk and isn't withdrawing LABAs from the market. Instead the agency is revising its recommendations on how the products should be used. The new recommendations are only for patients with asthma because there are no data regarding LABA risk in patients with COPD. The FDA's new recommendations include the following:
* Use LABAs only when asthma symptoms cannot be controlled with other asthma medications, but don't introduce the drugs during an acute exacerbation of asthma.
* Use LABAs in combination with other asthma medication, never alone. If the patient requires an inhaled corticosteroid and a LABA, a combination inhaler (such as Advair Diskus or Advair HFA, which are combinations of salmeterol and fluticasone or Symbicort, which is a combination of formoterol and budesonide) should be used. This is especially important in pediatric and adolescent patients. If the patient's asthma is treated with drugs that are only available orally, a single-product LABA may be added to the asthma drug regimen.
* Attempt to withdraw a patient from a LABA once asthma is better controlled.
Additional actions by the FDA to minimize the risks to patients from these drugs include the establishment of a risk evaluation and mitigation strategy (REMS). This plan will have three components. The first is the creation of a new medication guide to help patients learn about risks and involve them as active partners in drug therapy; the guide is to be given with each filled prescription. The second is education for health care professionals on the safe use and monitoring of these drugs. The final aspect of the REMS will require that drug manufacturers conduct clinical trials to determine whether the combination of a corticosteroid and a LABA actually decreases the safety risk. The current recommendation is an effort to prevent the use of LABAs as monotherapy.
NPs who prescribe LABAs should ensure that their practices adhere to these new recommendations. Nurses should emphasize several important points during patient education: patients who are started on a LABA inhaler must understand the importance of continuing with their other asthma medications; patients should also have a short-acting [beta]-agonist inhaler, such as albuterol, which is used several times per day as needed to alleviate bronchial constriction; patients need to understand that the LABA inhaler is for maintenance; it must be taken daily, and it won't alleviate an acute asthma attack. Nurses should also explain the information found in the medication guide before a patient starts drug therapy with a LABA and remind patients to read the guide thoroughly each time they fill a prescription for a LABA inhaler for the most up-to-date information. Patients should also be aware of signs that their asthma is worsening, and should be instructed to notify the prescriber immediately if those signs appear. Nurses should question any order for LABA therapy that's used as monotherapy for asthma control. For the FDA's page of questions and answers regarding the new safety requirements, go to http://bit.ly/c4O4RL. For more detailed information and links to other sources, go to http://bit.ly/a5312A.