FDA: Long-Acting Asthma Drugs Increase Asthma Risks

A Food and Drug Administration analysis of four drugs used to treat asthma said the products are linked with an increased risk of asthma-related side effects, with higher risks seen in children.

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.

It looked at whether the drugs increased a combined measure of asthma-related death, hospitalization and asthma-related intubation, or the placement of a tube in patients' noses or mouths to help them breathe.

The analysis was prepared for an advisory committee meeting next week to discuss the safety of the drugs as a class. The panel will be asked to vote on whether the drugs should continue to be marketed for children and adults.

The drugs fall into a class of medications known as long-acting beta-agonists, or LABAs, and have been the subject of an ongoing FDA safety review.

Agency memos released along with the analysis show the agency is divided over what course of action to take. The FDA's drug safety division is recommending that the drugs not be marketed for children, and in some cases adults, while the agency's pulmonary division stated that removing the products from the market would be "extreme."

The division noted that the drugs already carry a tough, "black box" warning stating they "may increase the risk of asthma-related death." The pulmonary division said the asthma-related deaths are "numerically small" and noted that overall asthma deaths in the U.S. have declined since 2000. The pulmonary division memo said the drugs have benefits such as improved lung function that "are not trivial for patients."  ... - wsj