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Health Agencies Update
February 19, 2003


JAMA. 2003;289(7):833. doi:10.1001/jama.289.7.833-a

The US Food and Drug Administration (FDA) has stopped a large safety study of the inhaled asthma drug salmeterol xinafoate (Serevent) after interim results suggested an increased risk of life-threatening events in some patients.

Although 28 000 individuals had enrolled in the study, the researchers agreed that continuing the trial would not yield clear results, because the number of life-threatening events was too low to reach statistical significance.

However, a subgroup analysis showed that black volunteers experienced a statistically significant heightened risk for life-threatening episodes. The FDA emphasized that fewer than 1% of blacks enrolled in the study experienced such events during the 28-week trial. Upon entering the study, black patients tended to have more severe asthma, which may explain why those patients had higher rates of serious adverse effects.

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