FDA sees asthma drug risks, seeks panel advice

U.S. regulators remain concerned about serious risks from a class of asthma drugs and will ask U.S. advisers next week if approval for treating the lung disease should be revoked, documents released on Friday said.

Staff in the Food and Drug Administration’s drug-safety office unanimously recommended withdrawing the approval of all long-acting beta agonist drugs, or LABAs, for children under age 18 amid evidence of an increased risk of asthma-related deaths and asthma attacks.

LABAs include GlaxoSmithKline Plc’s Advair and Serevent, AstraZeneca Plc’s Symbicort and Novartis AG’s Foradil, which Schering-Plough Corp markets in the United States.

The drug-safety staff, which monitors risks of drugs after approval, also urged removing the approval of Serevent and Foradil for asthma in people of all ages.

Serevent and Foradil contain LABAs only, while Advair and Symbicort combine LABAs with an inhaled steroid.

Adding the steroid may protect against serious complications, as Glaxo has argued. An FDA “meta-analysis” of several studies found the risk “was not apparent” in Advair or when a LABA was used with a steroid, agency documents said.

A memo outlining the advisory panel meeting said the agency would ask the outside experts if the drugs should still be approved for treating asthma. The panel meets Wednesday and Thursday.

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.

The drugs also are approved for treating chronic obstructive pulmonary disease and would remain available for treating that lung disease.

The makers of the drugs, in separate documents prepared for the meeting, said the benefits outweighed their risks when used as directed.

By Lisa Richwine
WASHINGTON (Reuters)