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Complications, Deaths Seen with Some Long-Acting Asthma Drugs

Dec 5, 2008 | Parker Waichman Alonso LLP

Some asthma drugs in a class  known as long-acting beta agonists (LABA) can increase the risk of death and complications, a new Food & Drug Administration (FDA) analysis has found.  The analysis 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 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.

LABAs  prevent the release of substances in the body that cause inflammation of airways in the lungs. In 2005, the FDA strengthened the warning labels for the asthma drugs to state that they should be reserved for patients who did not respond to other asthma therapies.  The label changes came after a study found that patients taking Serevent where four times more likely to suffer an asthma-related death.  Others showed that Serevent and Foradil increased asthma exacerbations and hospitalizations in both adults and children.

According to Reuters, the FDA's latest analysis found 2.8 more serious asthma events for every 1,000 asthma patients treated with a LABA. Children ages 4 to 11 "appeared to be at the greatest risk," FDA statisticians said. The risk is lower when the drugs are used together with a steroid to treat underlying inflammation deep inside the airways, Reuters said.

According to The Wall Street Journal, the analysis involved 110 trials and 60,954 patients. The bulk of the patients were from Serevent trials, with about 43,000 patients, the FDA said. The agency said there were 20 asthma-related deaths in the studies and of those, 16 were patients on Serevent and four were patients in the non-LABA group.

The analysis found that only one of the drugs, Advair - which combines an LABA and a steroid in one inhaler - does not appear to increase the risk of a serious event or death, the Journal said.  However, Serevent had a significantly higher rate of serious complications than the others.