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Warnings & Precautions
WARNINGS
DATA FROM A LARGE PLACEBO-CONTROLLED SAFETY STUDY THAT WAS STOPPED EARLY SUGGEST THAT SALMETEROL MAY BE ASSOCIATED WITH RARE SERIOUS ASTHMAEPISODES OR ASTHMA-RELATED DEATHS. Data from this study, called the Salmeterol Multi-center Asthma Research Trial (SMART), further suggest that the risk might be greater in African-American patients, in whom the increased risk was statistically significant at the time of the interim analysis. These results led to stopping the study prematurely (see CLINICAL PHARMACOLOGY: Clinical Trials: Asthma: Salmeterol Multi-center Asthma Research Trial). The data from the SMART study are not adequate to determine whether concurrent use of inhaled corticosteroids provides protection from this risk. Given the similar basic mechanisms of action of beta2-agonists, it is possible that the findings seen in the SMART study may be consistent with a class effect. Findings similar to the SMART study findings were reported in a prior 16-week clinical study performed in the United Kingdom, the Salmeterol Nationwide Surveillance (SNS) study. In the SNS study, the incidence of asthma-related death was numerically, though not statistically, greater in patients with asthma treated with salmeterol (42 mcg twice daily) versus albuterol (180 mcg 4 times daily) added to usual asthma therapy. Text Continues Below
SEREVENT INHALATION AEROSOL SHOULD NOT BE INITIATED IN PATIENTS WITH SIGNIFICANTLY WORSENING OR ACUTELY DETERIORATING ASTHMA, WHICH MAY BE A LIFE-THREATENING CONDITION. Serious acute respiratory events, including fatalities, have been reported, both in the United States and worldwide, when SEREVENT Inhalation Aerosol has been initiated in this situation. Although it is not possible from these reports to determine whether SEREVENT Inhalation Aerosol contributed to these adverse events or simply failed to relieve the deteriorating asthma, the use of SEREVENT Inhalation Aerosol in this setting is inappropriate. Page: 1 | 2 | 3 | 4 | 5 | Next >>
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