Glaxo asthma drug needs kid risk warning: FDA panel

Glaxo asthma drug needs kid risk warning: FDA panel
GAITHERSBURG, Maryland (Reuters) - U.S. regulatory adviserson Wednesday recommended strengthening safety warnings onGlaxoSmithKline Plc's asthma drug Serevent amid new reports ofdeaths in children taking the drug.
The U.S. Food and Drug Administration expert panel on drugsfor children reviewed nine new adverse event reports in kidstaking the inhaled treatment, including five deaths over aperiod of about a year, among other studies finding increasedhospitalization and asthma-related death in kids.
"The data is very troubling because both the increase inhospitalization and in mortality is so different" from whatdoctors currently believe, said Thomas Newman, anepidemiologist at the University of California, San Francisco,and panel member.
Serevent's use has fallen dramatically since originalreports of asthma deaths came to light a few years back. But itis one ingredient in Glaxo's blockbuster asthma drug Advair,and the new worries could impact that drug, which had $6.8billion in 2006 global sales.
At least two panel members said the data was so convincingthat Serevent should be pulled from the market. The FDA said itwill consider the safety of all drugs in the class, calledlong-acting beta agonists, at a future meeting.
"The members of this committee think this is an urgentpublic health issue," panel chairwoman Dr. Marsha Rappley, aneurology and psychiatry expert at Michigan State University,said.
Novartis also sells a long-acting beta agonist calledForadil.
FDA staffers said no date for the meeting has been set.
Advair contains Serevent plus a steroid. One theorysuggests that the steroid provides a protective effect againstthe negative impact of Serevent, but panel members rejectedthat idea.
"There is not evidence that the steroid mitigates the riskof asthma-related deaths in patients" taking Serevent, Rappleysaid.
In addition to recommending the label more prominentlydisplay the risk of asthma-related deaths, the group said thelabel needs to more prominently show the drug is recommendedonly when other treatments fail.
The FDA typically accepts the recommendations of theseadvisory panels.
Glaxo presented its own set of data rebutting anysuggestion of negative trends when salmeterol, the generic namefor Serevent, is used as directed.
Kathy Rickard, vice president for respiratory clinicaldevelopment at Glaxo, said the company believes data shows noincreased risk of hospitalization and mortality for Advair andshe is not aware of a pending FDA meeting on the issue.
Consumer group Public Citizen lists both drugs on its"worst pills" ranking, arguing their risks outweigh benefits.
Asthma is one of the most common chronic diseases inchildren, marked by restricted breathing and wheezing, andoften made worse by exercise, cigarette smoke and otherfactors.
About 6.5 million children have the condition in the UnitedStates, or about 9 percent of all children, according to theU.S. Centers for Disease Control and Prevention.