Canada. Health Canada is warning Canadians of the possible increased risks of asthma-related deaths associated with the use of a class of asthma drugs known as long-acting β2-agonists. The advisory includes safety information on the asthma medications formoterol (Novartis' Foradil; AstraZeneca's Oxeze), salmeterol and the combination products of an inhaled corticosteroid with salmeterol (Advair) or formoterol (Symbicort). The advisory is based on a Health Canada analysis of findings from the Salmeterol Multi-center Asthma Research Trial (the SMART study) in the US which showed that salmeterol appeared to increase the risks of asthmarelated death and other serious respiratory-related events; data from a SMART post-hoc analysis suggested that these risks may be greater in African-American patients and in patients not using inhaled corticosteroids at study entry. The increased risk with salmeterol may also apply to other long-acting beta-2 agonists such as formoterol although there is no current data to confirm this.
Health Canada recommends that:
• salmeterol and formoterol can only be used with an appropriate dose of inhaled corticosteroid as determined by a physician;
• long-acting β2-agonists are not a substitute for inhaled or oral corticosteroids;
• salmeterol (Serevent), formoterol (Foradil), or the combination of an inhaled corticosteroid with salmeterol (Advair) should never be used to treat acute or sudden onset of asthma symptoms and attacks;
• the combination product of an inhaled corticosteroid with formoterol (Symbicort) is not indicated for the treatment of sudden asthma symptoms and attacks;
• AstraZeneca's formoterol (Oxeze Turbuhaler) may be used on demand to treat acute symptoms in patients aged ≥ 12 years;
• medical attention should be sought if a patient's asthma medication becomes less effective or if patient needs more inhalations than usual;
• asthma therapy should not be stopped or reduced without first consulting the prescribing physician.
Advisories/Warnings. Health Canada, 4 October 2005 (http://www.hc-sc.gc.ca).