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    Acid-suppressing Drugs Being Over Prescribed in Infants

    Researcher warns that over-use can lead to serious consequences for children

    San Francisco, CA, October 20th, 2011 – Frequent spitting up, irritability and unexplained crying in infants are often very distressing to parents. Physicians frequently prescribe acid-suppressing drugs for these symptoms. However, gastroesophageal reflux disease (GERD) is an uncommon cause of these symptoms in otherwise thriving infants, and in his Commentary published in the October 20th issue of The Journal of Pediatrics, Dr. Eric Hassall cautions against the over-diagnosis of GERD and over-prescription of acid-suppressing drugs in this age group, ie, under 1 year of age.

    Dr. Hassall, Staff Pediatric Gastroenterologist at Sutter Pacific Medical Foundation, also part of the Medical Staff of California Pacific Medical Center in San Francisco, part of the Sutter Health network, and an advisor to the US Food and Drug Administration, traces the history and current uses of acid-suppressing medication in children and infants, mostly focusing on proton pump inhibitors (PPIs). He points out that clinical studies have shown PPIs to be highly effective in children 1-17 years of age who have proven GERD. In children under the age of one year, the use of these drugs has enormously increased in the last decade; a change in medical practice that Dr. Hassall says is not based in medical science. The rise of prescriptions owes a lot to direct-to-consumer advertising of pharmaceutical products, with its promotion of the misleading term "acid reflux", frequent self-misdiagnosis, and demand for medication. As Dr. Hassall observes, "it is recognized that more advertising leads to more requests by patients for advertised medicine, and more prescriptions; the term "acid reflux" as used in the marketing of PPIs to adults, has simply trickled down to infants." He points out that most "reflux" in infants is not "acid", because stomach contents have been buffered by frequent feedings.

    Randomized, controlled studies have shown that PPIs are no better than placebo for most infants with symptoms of spitting up and irritability, or unexplained crying. Dr Hassall explains that this is because the medications are frequently prescribed for symptoms that are not GERD. He emphasizes that spitting up in otherwise healthy, thriving infants is normal, and resolves with time; this is known as "physiological reflux". Because infants have a limited range of responses to stimuli, it can be difficult to diagnose their cause. Irritability or unexplained crying, with or without spitting up, is often a normal developmental phenomenon especially in infants 2-5 months or so, less commonly thereafter. Some infants, once crying, are unable to self-calm. This improves with maturation and age. "The state of being new in the world and getting used to new bodily sensations, such as gassiness", also may contribute. When severe unexplained crying occurs in otherwise healthy infants, prevalent causes include sensitivity to cow"s milk protein or other dietary components, including those that are present in breast milk. Nonpharmacological measures, such as dietary changes, together with "tincture of time" and reassurance, usually result in resolution.

    As Dr. Hassall explains: "In the absence of better information and physician guidance and fed by advertising and misinformation on the Internet, parent blogs have increasingly promoted the ""my-baby-has-acid-reflux-and-needs-drugs"" concept. Parents, concerned by their infant"s symptoms of apparent suffering, take their concern to doctors, who very frequently comply and prescribe acid-suppressing medications for symptoms and signs that in most cases are not GERD. GERD-mania is in full cry, so to speak."

    "We are medicalizing normality," Dr. Hassall asserts, "In most infants, these symptoms are "life," not a disease, and do not warrant treatment with drugs, which can have significant adverse effects." He explains that gastric acid is an early line of defense against infection, and important for nutrition, and by prescribing acid suppressing medications, especially PPIs, to infants without GERD, pediatricians are putting their patients at a higher risk for infections like pneumonia and gastroenteritis. The use of PPIs in infants can also lead to abnormalities in the levels of essential minerals and vitamins, such as magnesium, calcium, and vitamin B12.

    Dr. Hassall encourages his fellow pediatricians to opt initially for non-pharmacological approaches, such as changes in maternal diet of breastfeeding mothers, or hypoallergenic formulas for bottle-feeding infants. However, if these fail, or if an infant has severe symptoms and is suspected of having GERD, Dr. Hassall suggests beginning treatment initially with an histamine-2-receptor antagonist (such as ranitidine or famotidine) for a time-limited period of 2-weeks. If the infant does show improvement, dosage and length of treatment can be increased if necessary, or a trial of once-daily PPI started. However, as Dr. Hassall notes, "In most cases, it is not the spitting up that should be treated. The real issue is the unexplained crying, which causes real and considerable distress and concern for parents." He goes on to explain, "Parents can hardly be blamed for becoming rattled and concerned about their crying infant. It is important to acknowledge their concerns, explain the spectrum of normal infant behavior, discuss the range of measures available, start implementation, and be available for follow-up."

    The commentary: "Over-prescription of Acid-suppressing Medications in Infants: How It Came About, Why It"s Wrong and What To Do About It" by Eric Hassall MBChB, FRCPC, FACG appears in The Journal Of Pediatrics (www.jpeds.com), DOI 10.1016/jpeds.2011.08.067, published by Elsevier.

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