The Food and Drug Administration said there were concerns regarding serious side effects from three popular asthma medicines which could increase the hospitalization risk as well as death risk in some users. The three drugs in question are Serevent, manufactured by GlaxoSmithKline P. L. C.; Symbicort, made by AstraZeneca P. L. C.; and Foradil, from Novartis AG and U. S. advisors will review if approval for the drugs should be revoked at a two-day hearing next week in Rockville, Md.

The staff in the FDA office was unanimous in recommending the withdrawal of approval of all medications known as long-acting beta agonists, or LABAs for children below 18 years of age due to evidence that they increased the risk of asthma related deaths and asthma attacks. The drugs Serevent and Foradil contain LABAs only, while Advair and Symbicort combine LABAs with an inhaled steroid and the removal of approval of Serevent and Foradil for asthma in people of all ages was being asked for by the drug safety staff. No increased risk of respiratory complications was seen in a fourth drug, Advair made by GlaxoSmithKline which has about $4 billion in annual sales and is Glaxo's biggest product. An FDA "meta-analysis" of several studies found the risk "was not apparent" in Advair or when a LABA was used with a steroid.

Dr. Badrul Chowdhury, director of the FDA division that reviews pulmonary and allergy drugs, noted a "serious and significant safety risk" but added the asthma-related deaths were "numerically small" and the benefits were "not trivial". "Removal of inhaled LABAs from the market as a treatment for asthma is a way of managing the risk of these drugs, but would be an extreme approach that could be problematic," Chowdhury wrote.

In clinical studies, there were 20 asthma-related deaths, 16 in patients treated with LABA drugs, and four among patients taking other non-LABA medications. The FDA said, "All the asthma-related deaths were among Serevent-treated subjects."

Medical experts will at a two day hearing on Wednesday and Thursday examine the potential risks of all LABAs including Advair and will hear presentations by the drug makers, and make recommendations. The FDA staff said that people who seemed to at more risk were children in the ages of 4 to 11 who took these drugs, African Americans as compared to other groups and females as compared to males.

Timothy Anderson, analyst at Sanford C. Bernstein & Co. L. L. C., said, "Investors need to be mindful of these ongoing safety reviews by FDA and their potential commercial implication," he wrote. The drug makers have in separate documents prepared for the meeting, said when used as directed the benefits outweighed their risks.