A Food and Drug Administration report concerning four drugs used to treat asthma said the products are linked with an increased risk of asthma-related side effects, esspecially where children are concerned. The analysis, released Friday, looked at GlaxoSmithKline PLC's Serevent and Advair, Novartis AG's and Schering-Plough Corp.'s Foradil and AstraZeneca PLC's Symbicort.

The FDA analysis showed a "positive risk difference" for Symbicort, Foradil and Serevent, but only Serevent had a statistically significant increase in hospitalizations and deaths.

The agency has been reviewing the safety of medications known as long-acting beta agonists, or LABAs. Advair, Symbicort's closest competitor, was the only medication to show nearly no risk difference compared with patients taking another medication. Advair and Symbicort each combine a LABA with an inhaled corticosteroid.

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. "All the asthma-related deaths were among Serevent-treated subjects," the FDA said.

Moreover children ages 4 to 11 taking LABA drugs appeared to be at greatest risk for complications than those taking older treatments, FDA staff said. African Americans showed elevated risk compared with other groups, and females had higher risks than males.

The FDA analysis was prepared for an advisory committee meeting next week that is slated to discuss the safety of the drugs, The Wall Street Journal said. At the meeting, FDA advisors will consider whether LABAs should continue to be marketed for children and adults.

According to Reuters, the FDA’s latest analysis found all in all 2.8 more serious asthma events for every 1,000 asthma patients treated with a LABA. At the same time the pulmonary division claims the asthma-related deaths are "numerically small" and noted that overall asthma deaths in the U.S. have declined since 2000.