FDA ties pneumonia deaths to infant vaccine for diarrhea virus

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FDA ties pneumonia deaths to infant vaccine for diarrhea virus

Posted: 2008/02/17

From: Source

Food and Drug Administration 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.

WASHINGTON - GlaxoKline 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.