Serevent Side Effects May Lead To Death. David Graham, the U.S. Food & Drug Administration (FDA) researcher who questioned Vioxx‘s safety before it was recalled has recently raised safety concerns about Serevent. Recently a warning was added to Serevent concerning asthma-related fatalities in studies.
Data from a large placebo-controlled US study that compared the safety of Serevent (Generic: Salmeterol) and a placebo showed an increase in asthma-related deaths in patients receiving Serevent. In patients taking Serevent there were 13 deaths out of 13,176. In patients taking the placebo there were only 3 of 13,179.
An older study showed 36 patients taking Serevent died from asthma or had life-threatening attacks. Some patients taking Serevent have had trouble breathing and required intubations, the insertion of a tube into the throat forcing open the airways. Serevent is an aerosol spray. Patients usually use it twice a day to prevent asthma attacks.
Serevent Warning Label Update
The label for Serevent has been updated with a warning stating that the drug can increase the chance of severe asthma attacks that can result in death. The U.S. Food & Drug Administration (FDA) made this announcement on May 16, 2006.