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A study designed
to further evaluate the safety of asthma drug Serevent was
called off after an interim analysis showed more life-threatening
asthma episodes and asthma-related deaths in patients taking
the drug than in those taking a placebo.
The study was begun
in 1996 after the Food and Drug Administration (FDA) received
reports of several asthma deaths associated with use of the
drug. Preliminary data showed a small, statistically insignificant
number of adverse events in relation to use of the drug, however,
among African Americans taking Serevent the number or adverse
events, including deaths, was statistically significant.
Further, according
to national treatment guidelines, asthma sufferers should
take Serevent along with an inhaled corticosteroid daily.
Preliminary study data showed that patients who were not taking
inhaled corticosteroids at the study’s start seemed to
have greater risk for serious outcomes than those who were
taking inhaled corticosteroids.
Though the study’s
data was inconclusive, the adverse events were enough to cause
researchers to question why the events were happening, and
the study wasn’t designed to determine that. About 26,000
people had participated in the study so far, though the study
was intended to enroll 60,000 patients.
The FDA plans to
meet with Serevent’s manufactuer, GlaxoSmithKline (GSK),
to obtain more detailed data and determine what further steps
should be taken. Among the FDA’s top priorities is to
evaluate whether certain patients may be at an increased risk
for serious adverse events due to Serevent use. The FDA approved
Serevent in 1994 to treat asthma and later for use in the
treatment of chronic obstructive pulmonary disease.
However, the FDA
stressed that patients should not stop taking Serevent without
discussing it with their doctors. Based on the available evidence,
they say that the benefits of Serevent outweigh the risks
of adverse events.
About 20 million
people suffer from asthma in the United States, and an estimated
1.3 million take Serevent. The asthma drug is one of GSK’s
major sellers with worldwide sales of $929 million--$549 million
in the United States--in 2002. Analysts did not expect the
cancelled study to greatly influence the company’s economic
standing.
FDA
January 23, 2003
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