FDA ties pneumonia deaths to infant vaccine

updated 11:20 a.m. ET Feb. 15, 2008

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.

Don't miss this on msnbc.com Health Love and loss bind her to ‘other mother’ Sex is just one more chore on her to-do list The mystery of medications linked to suicide The Fit List: Get buff for the beach Free pens and pizza comes at a high cost for docs

Print this Email this Blog this  IM this

MORE FROM INFECTIOUS DISEASES

Infectious diseases Section Front

5 more die in China of child virus   Tests show no disease on quarantined train More hepatitis cases may trace to Vegas clinic Death toll from child virus reaches 30 in China China wants reports of all kids with fatal virus Risk of bird flu pandemic growing, officials say 12,000 children in China now have deadly virus Who should doctors let die in a pandemic? 286,000 pounds of meat, poultry recalled Chronic Lyme disease? Docs may change stance Infectious diseases Section Front   Add Infectious diseases headlines to your news reader: