In a report posted on the FDA's Web site Friday, the agency said at least five users of Serevent, one of Glaxo's biggest-selling medications, died while taking it in the 13 months after U.S. approved its use for children in 2006. Four others under the age of 16 were harmed.
The findings were made after the FDA conducted a safety review on Serevent and Advair. The results will be discussed to a panel of pediatricians on Nov. 27 and thereafter. The advisory group may then recommend possible government action.
It was not the first time that FDA cited Glaxo's asthma drugs for its potential danger.
Two years ago, FDA also advised consumers to limit the use of the drugs to patients who don't benefit from other similar medication after a study found chances of asthma-related deaths among Serevent users increase 400 percent.
In 2004, the agency also included Serevent among the top five most dangerous prescription drugs on the U.S. market.
"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.
It noted the risks of Serevent use outweigh the benefits.
Asthma is a chronic respiratory illness that causes inflammation and narrowing of airways in the lungs. Serevent and Advair are used to prevent exacerbation of asthma by relaxing the airways.
Global revenues of Glaxo's bestsellers reached $6.13 billion in 2006, increasing the previous year's sales by 12 percent.
Possible side effects of Serevent and Advair include allergic reactions manifested by difficulty in breathing; throat, lips, tongue or face swelling; dry mouth and nausea; and headaches and dizziness.
