Explosion of PPI Use in Young Children

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.   

Photo courtesy bbaunach at Creative Commons (flickr)

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. 

The meeting will probably be a joint meeting of the Pediatric Advisory Committee  and the Gastrointestinal Drugs Advisory Committee 

–Elizabeth Mechcatie (twitter: @elizmech)

A Welcome Mat For Dads

In an upcoming “Behavioral Consult” column in Pediatric News, Johns Hopkins University pediatrician Barbara Howard talks about the many ways in which fathers uniquely contribute to their children’s health and well-being, and encourages pediatricians to make them feel comfortable and necessary during visits, right from the start.

Her many suggestions range from the utilitarian — offering Dad-friendly magazines and an extra chair in the exam room — to the insightful: emphasizing the infant’s strength and engagement during the well-baby exam and showing Dad how comfy his progeny feels in the “football hold.”

Image via Flickr user Narith5 by Creative Commons License

The discussion made me reflect on the fathers in my life and their connections with pediatricians. My own father seemed to know Dr. Snyder, but mostly from my mother’s amused recountings of our doctor’s dry wit and straight-faced pronouncements of medical truths (or falsehoods?) My husband, on the other hand, was a regular presence in the pediatrician’s office, always setting a bad example for the kids by playing with the blood pressure cuff or checking out the “knee hammers” in the drawer.

Where my husband’s great value lay was in negotiating the minor emergency phone line when one of our kids had a fever, gash, or cough. While my calls always seemed to be met with bored professionalism on the part of the triage nurse or the front desk assistant, we quickly realized that a call from DAD meant there must surely be an EMERGENCY. My hunch was that the voice of fatherhood was so unusual in the daily rhythm of the pediatric office that everyone took notice when a real dad was on the phone. The appointment was made pronto. The doctor called back immediately. We were no longer alone in our child crisis.

If pediatricians take Dr. Howard’s advice and brush off the welcome mat for Dads, I guess that eventually they’ll have to sit on hold just like moms have been doing for years.

— Betsy Bates