Glaxo confident as FDA probes asthma drugs in kids

Glaxo confident as FDA probes asthma drugs in kids
LONDON (Reuters) - The safety of GlaxoSmithKline Plc'stop-selling asthma drugs Serevent and Advair is back in thespotlight this week as a U.S. regulatory panel meets toconsider their safety in children.
Europe's biggest drugmaker said on Monday it remainedconfident the benefits of its products outweighed any risks.
Concerns about rare and potentially fatal side effects wereraised in briefing documents posted by Food and DrugAdministration staff ahead of a November 27-29 meeting of theagency's Pediatric Advisory Committee.
There were nine cases of adverse events in children under16 using Serevent, or salmeterol, in the year followinggranting of pediatric market exclusivity in March 2006,including five deaths, papers posted on the FDA Web site show(http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4325b_03_05_Salmeterol%20Adverse%20Event%20Review.pdf).
Serevent, a long-acting beta agonist used to easebreathing, is also included in Advair, Glaxo's biggest productwith worldwide sales of 3.3 billion pounds ($6.8 billion) in2006. U.S. sales accounted for 1.9 billion pounds last year.
The British-based company said it had provided clinicalinformation to the FDA, which it believed backed the safety ofboth products.
"GSK has submitted a thorough safety review ofsalmeterol-containing products in pediatrics. The overallassessment of the data confirms the favorable safety andefficacy profile of Serevent and Advair when used according tothe product labels," a spokeswoman said.
"GSK believes the product labels reflect the availablesafety information for children four years of age and older."
It is not the first time that rare adverse events have beenreported with Advair and Serevent and industry analysts saidthe latest regulatory scrutiny would probably not have anyimmediate impact.
"While the FDA's attention is unwelcome, any formaladditional recommendations against use in children that wouldsignificantly affect prescribing behavior would seem some wayoff," analysts at Deutsche Bank said in a note.
The FDA already issued a warning in November 2005 thatdrugs containing long-acting beta agonists, such as Advair andSerevent, can sometimes paradoxically trigger severe asthmaattacks and death.
(Reporting by Ben Hirschler; Editing by Jason Neely)