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MagazineMarch 2003 (Vol. 13 Issue 12)Serevent

The wheels of power in medicine lurch slowly, and there are occasions when it's as well to be considered and reflective

The wheels of power in medicine lurch slowly, and there are occasions when it's as well to be considered and reflective. These virtues become vices, however, when lives are at risk.

Take, for example, Serevent (salmeterol xinafoate), a beta-agonist inhaler designed to treat asthma. Deaths were linked to the drug within a couple of years of its being approved and so, in July 1996, GlaxoSmithKline, the manufacturer, started the Salmeterol Multicenter Asthma Research Trial (SMART) in America to test the drug against a placebo. The trial ran for seven months, and so was completed in December that year.

Since then, it has taken six years to analyse and publish the findings, and the conclusions are so damning that plans to continue the trial have been abandoned - because Glaxo can't find new volunteers willing to take the drug.

The findings provide yet more evidence that the drug is responsible for life-threatening asthma attacks and asthma-related deaths. The major concern is among African-Americans, who had a significantly greater number of severe asthma attacks and deaths compared with the placebo group.

The US the Food and Drug Administration (FDA) is taking the findings very seriously, although it has not yet banned the drug. At the moment, it says, the benefits still outweigh the risks, and patients should not suddenly stop the treatment.

GlaxoSmithKline has told doctors that patients with worsening asthma, or acute symptoms, should not be given the drug.

Aside from death, reactions include headache, upper respiratory tract infection, palpitations, laryngitis, nausea, tooth pain, back and joint pains, fatigue, bronchitis and skin eruptions.

All of this is very worrying, but rest assured that, eventually, given enough time and after careful consideration, the drug regulators may - or may not - act.

False prevention

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