Serevent, a powdered medication inhaled by asthma patients to keep their airways open, will be a focus of an FDA Pulmonary-Allergy Drugs Advisory Committee meeting today as it has been linked to 13 deaths related to asthmatic symptoms in patients who took the drug to avoid asthma attacks.
FDA documents released yesterday indicate that about a year ago, the agency asked Glaxo to strengthen Serevent’s existing so-called black box warning, the most serious a drug label can carry. The FDA wanted the label to say that a study found a “a small but significant” risk for asthma-related deaths in all Serevent users and not just African-Americans, as previously indicated.
Although Glaxo halted its study of Serevent in 2003 after finding that it couldn’t enroll enough people and that there was a slight increase in asthma-related deaths in Serevent patients compared to those taking a placebo, pulmonologist and vice president of Glaxo’s respiratory medicine development center, defended Serevent, saying that the drug had actually proven to be very effective. However she suggested that Serevent patients should take it with corticosteroids and those who do not could be at increased risk for asthma attacks.