FDA Gets Fooled Again About Toxic Asthma Drug

The consumer watchdog group, Public Citizen, is at it again, with a letter in this week's Lancet blasting GlaxoSmithKline (GSK) for presenting misleading findings about the popular and potentially deadly asthma drug, Serevent (salmeterol) to the FDA.

The conflict involves GSK's failure to report that some of the study findings it had released about Serevent occurred six months after the drug trial ended. Based on the original 28-week study, Serevent increased an asthmatic patient's risk of death. Adding the extra data after the study ended, Public Citizen says, merely waters down Serevent's risks making them appear lower than they truly are.

After hearing about the discrepancy, an FDA advisory committee recommended strengthening the warning for Serevent as well as Advair (another GSK product that contains both steroids and beta agonists) but no final ruling has been issued.

Though some experts believe GSK played ''by the rules'' here, it's worth reminding you Serevent was one of the five drugs, in addition to Vioxx, that were named by Dr. David Graham during his Congressional testimony nearly a year ago as putting the lives of the public at great risk.

Public Citizen.org October 7, 2005

Yahoo News October 7, 2005

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