February 15, 2008
Agency panel considering approval of oral medicine for diarrhea virus
WASHINGTON - GlaxoSmithKline Plc's rotavirus vaccine is associated with increased pneumonia-related deaths and other adverse reactions, U.S. regulatory staff said in documents posted on Friday.
The review comes ahead of a Food and Drug Administration advisory meeting next Wednesday to consider approval of the oral vaccine to prevent the most common cause of severe diarrhea and dehydration among infants and young children in the world.
FDA staff said its analysis of 11 studies revealed that in the largest trial, there was a statistically significant increase in deaths related to pneumonia compared with placebo, documents posted on the FDA's Web site said.
That study, which enrolled about 63,000 children, also found an increase in convulsions in children given the drug, named Rotarix. Another study found an increased rate of bronchitis, compared with placebo.
In a conclusion section, the FDA documents noted the pneumonia-related deaths and convulsions, but did not appear to make a recommendation to the advisory panel.
That expert panel will weigh the staff review, but makes its own recommendation, which is typically followed by the FDA.