Members of the FDA’s Pediatric Advisory Committee were surprised by the exponential increase in proton pump inhibitor (PPI) prescriptions dispensed for young children over the past few years, after hearing an FDA presentation on pediatric adverse event reports for PPIs at a meeting last month. But what really struck them was news that infants under age 1 had the steepest increase of all.
In her presentation, Dr. Amy Taylor, a medical officer on the pediatric and maternal health staff in the FDA’s Office of New Drugs, presented outpatient prescription data obtained from Vector One for PPIs in children and adolescents between 2002 and 2009. It showed that for children from birth through age 17, the number of prescriptions increased from 875,000 in 2002 to 2.6 million in 2009–a threefold increase. The number of patients prescribed PPIs in this age group increased in the same proportion, from 332,000 in 2002 to 885,000 in 2009.
Now here are the really striking numbers: In children under age 1, PPI prescriptions grew from 37,000 to 403,000 in the same period–an 11-fold increase. The number of patients in this age group prescribed a PPI increased from 18,000 to 145,000, an 8-fold increase.
But none of the PPIs approved in the United States are approved for use in children younger than 1 year. (Esomeprazole, lansoprazole, and omeprazole are approved for gastroesophageal reflux disease [GERD], erosive esophagitis, and/or maintenance of healing of erosive esophagitis in children ages 1 and older; rabeprazole is approved for GERD in ages 12-17 years.)
Pediatric use of PPIs and the effectiveness of these drugs in pediatric populations is a topic that the FDA is looking at more closely. During the discussion, Dr. Joyce Korvick, deputy director for safety in the FDA’s division of gastroenterology products, informed the panel that the agency is planning an advisory panel meeting on clinical trials on the effficacy of PPIs in pediatric patients in November. Dr. Dianne Murphy, director of the FDA’s Office of Pediatric Therapeutics, remarked that when she saw the prescription use data, “I just about fell out of my chair,” and said that one of the reasons the meeting is planned is “we’re learning how much we don’t know” about the use of PPIs in pediatrics.
They both indicated that questions raised by panelists during the discussion-which included how efficacy in older children is extrapolated to those under age 1, the differences in reflux disease across age groups, and the use of PPIs in premature babies–will be addressed at that meeting.
–Elizabeth Mechcatie (twitter: @elizmech)