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Safety Officials at the U.S. Food and Drug Administration
reported that GlaxoSmithKline Plc’s asthma drugs Serevent and Advair, the
company’s biggest-selling medications, might have rare and deadly side effects
for children. The third asthma drug is called Foradil and is manufactured by
Novartis.
Asthma is a chronic respiratory disease which causes
inflammation and narrowing of airways in the lung. Serevent and Advair are both
used to prevent exacerbation of asthma by relaxing the airways. According to
the National Institutes of Health, almost one in ten Americans is diagnosed
with Asthma at some time. Almost 21 million adults and 9 million children in
the U.S.
are currently suffering from this condition.
The medications were approved for children in 2006 in the
U.S. Nine patients under age 16 were harmed, including five who died, while
being administered Serevent in the last 13 months, according to a safety review
posted on the FDA’s Website on Friday.
A meeting of well-known pediatricians to discuss side
effects from Serevent and the other medications is scheduled on November 27.
Glaxo’s asthma drugs were being reported as dangerous by the
FDA on other occasions too. Two years ago the agency advised consumers to limit
the use of the drugs to patients who do not benefit from other similar
medication following a study which showed chances of asthma-related deaths
among Serevent users increase 400 percent.
The FDA included Serevent among the top five most dangerous
prescription drugs on the U.S.
market on 2004.
"There is no available pediatric data to indicate that
the increased risk of asthma death and life-threatening exacerbations observed
in adults does not also apply to children," the latest FDA report noted.
Serevent has more risks than benefits, according to the
FDA’s report.
Allergic reactions manifested by difficulty in breathing,
throat, lips, tongue or face swelling, dry mouth and nausea, headaches and
dizziness number between the possible side effects of Serevent and Advair.
Glaxo’s bestsellers gained $6.13 billion worldwide in 2006
and increased the company’ sales by 12 percent. This revenue made the medicines
the second-best-selling in the world behind cholesterol drug Lipitor belonging
to Pfizer Inc.
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