GSK’s Rotarix associated with pediatric convulsions, pneumonia

According to a review by the Food and Drug Administration, GlaxoSmithKline’s rotavirus vaccine, called Rotarix, is associated with an increased risk of convulsions and pneumonia-related deaths in children taking the drug.

Rotavirus is the most common cause of severe diarrhea and dehydration among infants and young children.

The study, which enrolled about 63,000 children, found a significant increase in convulsions and deaths related to pneumonia compared with a placebo, the review says.

The staff review is one consideration among many that an expert panel at the FDA will weigh when deciding whether to approve the drug.