This blog is a commentary on the article Reflux Drugs Tied to Bone Fractures in Children and describes my approach to prescribing medications.
This article is important for not just parents and families, but perhaps even more so for doctors and advanced practitioners (nurse practitioners and physician assistants) who care for and treat infants and children—including those in my own specialty of ear, nose, and throat.
It is so common when I meet parents for them to tell me their child had “reflux” as an infant and was treated with either Raniditine (Zantac, Pepsid), a H2 histamine receptor blocker, or proton pump inhibitors (Nexium or Prilosec). Both are medications commonly prescribed for gastroesophageal reflux, and prescribed by the millions in the US to adults and even children for “acid reflux”. This new study, published in the Journal of Pediatrics, suggests that these medications may increase the risk for bone fracture later in childhood.
Researchers studied records of more than 850,000 children up to 14 years old. About 97,000 had received acid suppression medicines in their first year of life—8,000 were prescribed proton pump inhibitors like Nexium; 71,000 took histamine-2 receptor antagonists like Pepcid; and 18,000 got both. The group that received PPIs before age 1 were at a 23 percent increased risk for fracture. There was a 31 percent increased risk when the infants took H2 antagonists at the same time. The risk increased with longer use, but did not increase when H2 antagonists were used alone. This study adjusted for gender, premature birth, low birthweight, conditions that are known to cause fracture, previous fracture, overweight or obesity, and those on medications already known to increase the risk of fracture. The results were independent of all these factors listed, meaning the increased risk of bony fracture is not due to any of these factors but associated specifically with acid reflux medications.
As a Pediatric Ear, Nose, and Throat Specialist, I remember early in my career a single moment when I decided to STOP prescribing anti-acid and anti-reflux medications to newborns and infants for “spit up”, especially whenever we were consulted by the Neonatologists about newborns who had noisy breathing.
Our training, or perceived “standard of care” at that time was when a newborn or infant had noisy breathing, often due to structural differences in their voice box, we believed acid reflux would make them worse or more noisy. Therefore, by prescribing Raniditine, we good doctors were preventing babies and infants or anyone from experiencing acid reflux.
After serving for 2 years on a committee at the hospital along with GI Specialists and others, and reviewing the literature and research on spit up in children, I learned that blocking natural stomach acid secretion did not result directly or definitely in actual “reflux”, or episodes of stomach content coming up to the esophagus, or even “spit up”. Furthermore, there was no research evidence that using Raniditine would decrease noisy breathing. So I stopped recommending it. I remember the chief of Neonatology (doctors who care for newborns in the neonatal intensive care units) shared that from his team’s perspective, every consult to my team pretty much included a recommendation to use either Raniditine or, when that didn't seem to work, the stronger acid suppression which is a proton pump inhibitor. He was right. I decided then and have continued for over 15 years, luckily, to make sure that prescribing these medications was an exception for me, not a rule. Even when I felt the benefits outweighed the risks, I made sure I prescribed a course of just a few weeks, and took babies and children off of medications as soon as possible or if the symptoms were not any better when on the medications. That’s my approach with ALL medications.
“Redness” of the tissue, and throat, and area around the voice box turns out to be highly subjective and not directly correlated to any disease spectrum, or at least not without other signs based on research in my field when it comes to the voice box and airway.
Instead, I learned to take the time to really listen to parents, look at whether the “spit up” was really causing weight loss and other issues, and a medical concern. If not, I learned how to reassure parents that this is most often a “phase” and as the infant grew older, it will pass. Still, there are countless well intentioned pediatricians and other specialists who have continued to prescribe these medications, and I am grateful a large scale and scientifically sound study has been done to show the risks of these medications.
Medications can be life-saving, such as chemotherapy and immunotherapy, anti-seizure medications, anti-blood clotting medications, and so many other incredible scientific discoveries we have thanks to the pharmaceutical industry. The key is that benefits must outweigh the risks, but how prepared and aware are all doctors who prescribe on the risks of these medications? Short term and more importantly, long term? We rely on solid research, but even then, how many doctors will have read this research article and commit to making a change in their approach?
I can think of several medications that were “trendy” at the time they were new and widely prescribed for adults, that later on we hear the FDA has either pulled the drug or put a warning on it, because they have come to find out the side effects caused greater risks and problems that doctors were not aware of at the time they prescribed it. Doctors are incredible healers, but we have been taught to focus on diagnostics, medications, and surgeries and in my humble opinion, no longer taught or supported in our art of healing that requires years to hone through incredible doctor-patient relationships.
Medications have side-effects, they nearly always do. Ask questions the next time your child is being prescribed medications. Ask about known benefits and risks, and if the doctor would put his or her own child on the medication prescribed, and for how long.