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Public Citizen claims drugmaker misled FDA about Serevent study results

–October 7 , 2005

Consumer group Public Citizen has accused GlaxoSmithKline of giving misleading study results to the FDA involving its popular asthma drug Serevent (salmeterol).

GlaxoSmithKline denies the group's charges that claim the drugmaker was trying to hide the extent to which Serevent can cause asthma related deaths, saying they followed FDA protocol and alerted physicians about potential Serevent dangers.

Serevent belongs to a class of drugs called long-acting beta agonists and is designed to relieve asthma symptoms by opening the airways, but it is meant to be taken along with an inhaled steroid, which reduces inflammation. Another Glaxo drug, Advair, contains both drugs.

Public Citizen director Dr. Sidney M. Wolfe said GlaxoSmithKline misled the FDA about the increased risk of Serevent asthma death, and as a result, Wolfe said the FDA complained about the delay in realizing the increased risk of asthma death existed. Serevent was given to decrease deaths from asthma, but Wolfe said the failure to fully disclose the drug's actual risks was "reckless and dangerous."

The Serevent debate is in regards to the company's failure to report that some study results provided to the FDA actually occurred six months after the trial had ended. In a letter by Wolfe and his colleague Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group, data outside the trial period is corrupted because it is not known whether the people included in the trial continued on the same drug regimen as during the trial.

The watchdog group was also concerned with the fact that results of the trial have never been published. When the FDA's Pulmonary-Allergy Drugs Advisory Committee learned of the Serevent problems, both Serevent and Advair labels were strengthened to better warn about possible risks.

The FDA has yet to make a final decision. Public Citizen believes the agency cannot be blamed that the company misled them, but the delay in the advisory committee meeting has allowed the dangerous drugs to remain on the market for even longer.

Both sides argued the Serevent debate in two letters in the Oct. 8 issue of The Lancet.

For more information on Serevent concerns, please contact us.


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