Triangle Business Journal - November 29, 2007
http://triangle.bizjournals.com/tria...6/daily32.html


Thursday, November 29, 2007
FDA panel wants extra warnings on Glaxo asthma drugs Advair,

SereventTriangle Business Journal
GlaxoSmithKline's best-selling drug Advair, manufactured in part at a plant in Zebulon, may get new warnings on its label highlighting the drug's risk for children.

A Food and Drug Administration advisory panel said late Wednesday that the asthma treatment's label should contain more information about its potentially deadly side effects in children.

The FDA panel also said the information should be placed on the label of Serevent, another GSK asthma drug with the same active ingredient as Advair. The full FDA is not obligated to follow the recommendations of its panels, though it usually does.

Serevent and Advair already carry warnings, added in 2006, that say the drugs could increase the risk of asthma-related deaths. The FDA determined that the drugs should stay on the market, however, because they're highly effective in treating asthma despite the risk.

Wednesday's advisory panel ruling calls for more information to be added specifically about the drugs' risk in children, who get more than 10 percent of Advair prescriptions. Some panel members said they don't think the benefits of Advair and Serevent outweigh the drugs' risks in kids.

In a written statement, GSK disagreed.

"GlaxoSmithKline believes the products are appropriately labeled; however, we will continue to communicate with the U.S. Food and Drug Administration regarding today's decision," the company said. "There is no new safety information that changes the benefit-risk evaluation of Serevent or Advair which warrants another review at this time. GlaxoSmithKline is committed to the continued monitoring and safety evaluation of all of its products."

About 1,000 workers in Zebulon work to manufacture Advair, which brought in nearly $7 billion to GSK in 2006. The drug contains the active ingredient in Serevent plus a steroid that is meant to help the drug function more effectively.

The FDA panel's decision came just hours after another ruling on a GSK drug. An FDA panel said Wednesday that the company's flu treatment Relenza should carry warnings about potential psychiatric side effects.

GlaxoSmithKline (NYSE: GSK) employs about 6,000 people overall in the Triangle.



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