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Does your baby have reflux? Study questions safety of often-prescribed meds

Acid suppressors being given to infants, despite FDA's non-approval, JAMA says

  • Many babies have some form of GER, or acid reflux -- but a report questions whether we need to treat the condition with medicines such as PPIs and H2-blockers.
  • Is reflux "just spit-up?" It can be. It can also be something more serious, doctors say.
  • The connection to bone health: What can be the effects, or possible effects, of taking these medications as babies?
  • Does timing and duration of these meds matter? This report from health experts says yes.

Gastroesophageal reflex -- also known as GER, or acid reflux -- is a common condition that many babies experience; in fact, a report from The JAMA Network said that 65 percent of infants experience some form of it: spitting up, that is.

JAMA, by the way, is the Journal of the American Medical Association, a peer-reviewed medical journal published by the American Medical Association.

But back to the spit-up: Luckily, most babies grow out of it by their first birthday as their digestive tracts mature.

When it comes to dealing with the problem, what are a parent's options? You can burp the baby and have a towel ready, as your grandma might tell you. And although it’s a nuisance for parents and caregivers alike, that’s been one of the most basic and time-tested remedies.

However, it appears that in recent years, doctors have been prescribing something a bit stronger.

A study that JAMA wrote about in September and October 2016 is questioning the use of acid suppressors, which doctors are prescribing more and more, to curb mild infant reflux.

“ … Physicians have been increasingly prescribing powerful stomach-acid suppressors, such as proton pump inhibitors (PPIs) and histamine2 receptor antagonists (H2-blockers), to otherwise healthy infants with GER,” the JAMA article reads. “However, evidence suggests these drugs don’t reduce symptoms of even more serious reflux conditions in infants -- or crying and irritability in infants that is often presumed to be a sign of reflux. Safety concerns have also recently emerged, with new findings that suggest giving the drugs to infants younger than 6 months of age is associated with a higher risk of bone fractures later in childhood.”

That’s news. To reiterate, and in more common terms: Physicians have been prescribing PPIs and H2-blockers to otherwise healthy babies, and the evidence suggests that these drugs aren’t even reducing reflux symptoms for everyone, according to the report. Perhaps what’s even more serious is that giving these drugs to infants who are younger than 6 months of age can lead to a higher risk of bone fractures later in the child’s life, the study says.

Yikes.

But is reflux really ‘just spit-up?’ Mom shares family’s story

Cassy Dreffs, who lives in Michigan and works as a nurse in the Metro Detroit area, dealt with reflux in her son, Kai, starting very early on.

“By 1 month of age, Kai was spitting up after every feed,” Dreffs said. “We were supplementing with formula after some feeds as I built my supply back up after mastitis. (His) reflux seemed worse when formula was given. When he would spit up, he would scream and seemed to be in so much pain.”

Dreffs described Kai as a very unhappy baby most of the time, who usually needed to be positioned upright.

“We mentioned it to our pediatrician at the one-month well visit and he recommended probiotic drops and eliminating dairy from my diet -- (and) I already had (done that) for a few weeks,” Dreffs said. “By the 2-month well-visit, there were no improvements and it may have been worse.”

Kai was eventually prescribed Zantac, which is the brand name for ranitidine -- an H-2 blocker. Dreffs couldn’t recall Kai’s exact age when he started taking it, but it was around the same time that the family was learning a lot more about Kai’s struggle with feedings and reflux.

“I had started seeing a lactation consultant around six weeks, and she thought (Kai) had a tongue tie and gave us a few tips and things to work on,” Dreffs said. “After a couple weeks, she referred us to a dentist who specializes in tongue ties. So at nine weeks, he had a tongue and lip tie revision. His reflux improved probably 50 percent after the revision.”

Finally, there was some relief.

Still, at Kai’s 3-month appointment, his dose of Zantac was increased, Dreffs said, and she was told that she and her husband “could” start giving Kai rice cereal in his bottle.

The recommendation definitely made her hesitate.

“When I questioned our first pediatrician about his recommendation of rice cereal to ‘solve’ the problem, he became defensive and said that he wrote a research article about it when he was a resident -- many, many years before,” Dreffs said. “I found he wasn't up to date with current -- CDC, WHO and AAP -- recommendations to wait until after six months, (saying) that cereals could be used, but weren't ‘required.’”

When asked about what or who she trusts when it comes to medical advice, especially considering her position as a nurse, Dreffs said she dabbles in some Googling, but also uses her resources, such as the doctors at work, to gather different opinions and perspectives.

“I did more research on early introduction of solids (especially cereals) than on the medications,” she said. “We knew something was wrong with Kai and we wanted to help fix it as best as we could.”

They also switched pediatricians around this time.

At Kai’s 4-month well-visit, the family was given a prescription for Prevacid, which is a PPI, and they were advised to continue using the Zantac.

“Kai was still spitting up after most feeds, but he didn't seem uncomfortable like he did the first few months of life,” Dreffs said. “Prevacid helped, but (he) still struggled with weight gain. At five months, we saw a pediatric gastroenterologist. She stopped the Zantac and changed the dose of Prevacid. (She) encouraged starting solids at that time, as well. Within a couple of weeks, (the) spit-up was drastically reduced. He was also sitting up mostly unassisted. He stayed on the Prevacid until eight or nine months, and we slowly weaned off of it, and he did well.”

Dreffs said she and her husband continued to use some Zantac occasionally, like when it seemed as if Kai’s reflux was flaring up. But he was off the medications by the time he turned 1, “and he’s been doing great in the reflux department since then,” Dreffs added.

The family also tried gripe water, a non-prescription product aimed at relieving discomfort in infants, and mylicon drops -- which are meant to decrease gas.

“But nothing was magic,” Dreffs said.

Kai is now a happy, healthy toddler. As for Dreffs' journey in Kai’s first year of life, wading through different recommendations, procedures and medications, it was challenging, at times. In the end, it’s not clear as to what exactly solved Kai’s reflux.

“I like a combination of Western medicine and natural or Eastern practices, but I felt like Kai was at a critical time in his development,” Dreffs said. “He was struggling to gain weight and had quickly fallen off the growth charts, (so I) put my faith in the Western medicine. In the end, we don't have an answer as to what really worked the best for Kai. Maybe the meds, tongue tie revision, maturity of the esophageal sphincter, sitting upright, starting solids a month earlier than I'd hoped, or a (maybe it was a) combination of everything.”

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By the numbers

Dreffs isn’t alone. Although perhaps not every parent has followed the same path -- struggling with his or her child’s weight gain, or trying different medications or procedures -- it’s easy to find thousands of parents in support groups on Facebook, such as one with nearly 10,000 members called “Acid Reflux Babies Support Group.”

Many parents write posts in the group, detailing their struggles with finding an effective solution for their baby’s reflux, general discomfort and others issues tied to GER. 

Still, keep in mind: PPIs and H-2 blockers are not approved by the FDA in infants, according to the JAMA study. Yet many parents are being advised to use these medications on their babies. For some moms, including Dreffs, they were worth it, considering the circumstances.

But it feels safe to say, new parents with babies who spit up shouldn't necessarily jump straight to the prescription medications.

So, let’s talk numbers: PPI prescriptions among infants younger than age 1 increased fourfold from 1999 to 2003, and 7.5-fold from 1999 to 2004 (when partial data from 2004 were included), according to a 2007 study cited by JAMA.

But there’s another caveat to consider.

“(These numbers come) despite the fact that, at the time, no PPI was approved by the U.S. Food and Drug Administration for any use in children younger than 1 year,” the JAMA report said. “More recently, esomeprazole and omeprazole have been approved by the FDA for use in infants aged 1 month to 1 year, but only for erosive esophagitis due to acid-mediated gastroesophageal reflux disease (GERD), a far more serious condition than GER.”

Keep that last part in mind: GERD, although it’s only one letter off from GER, is indeed a far more serious condition. Many babies experience some type of GER, but GERD is more rare. We’ll come back to this difference soon.

For now, let's revisit our numbers discussion and the FDA. Why were so many doctors prescribing these medications without FDA approval? And why is mild reflux something that doctors have to treat at all? We asked an expert that very question.

“Generally, reflux is not something that needs to be treated aggressively,” said Dr. Frank McGeorge, a health reporter who also works as an emergency room doctor. “Occasionally, (reflux) can be related to periods of apnea or even aspiration pneumonia -- and if that’s the case, we sometimes go after it. Other than that, it is just super annoying for parents when the child continues to spit up on them and their caregivers.”

It likely won’t last forever, though. Remember, research shows that most babies grow out of it by the time they turn 1.

“My daughter had really bad reflux,” McGeorge said. “Obviously, she outgrew it since she is in college now -- and does not throw up all the time.”

Diving into bone health

As for the connection to bone health, we’ll let JAMA explain.

"The evidence tying acid suppressors to bone deficiency comes from the first-of-its-kind retrospective cohort study of 874,447 children without diagnosed GERD, born within the Military Health Care System from 2001 to 2013. All had received follow-up MHS care for two or more years, with a median of 5.8 years and a range of 3.6 to 9.1 years. Outpatient pharmacy data from the first six months of life identified prescriptions for PPIs in 6,943 infants, H2-blockers in 67,096, and both in 10,777, or about 10 percent of the entire cohort. The researchers used the International Classification of Disease, Ninth Revision, codes to identify fractures after six months of age and calculated hazard ratios adjusting for confounding factors including sex, prematurity, and low birth rate.

The study, which was presented as an abstract at the Pediatric Academic Societies meeting this past May in San Francisco, found that children who received PPIs in the first six months of life had a 22 percent increased likelihood of fractures at a median 5.8 years following PPI use. When the drugs were used in combination with H2-blockers, the hazard climbed to 31 percent. The H2 blockers alone were not associated with a statistically significant hazard, according to the study’s lead author, U.S. Air Force Capt Laura Malchodi, MD."

Still with us? There were a lot of numbers and details in there.

Did you catch these figures? Children who received PPIs in their first six months of life had a 22 percent increased likelihood of experiencing fractures (at a median age of 5.8) following the PPI use, the report said.

And when the drugs were used in combination with H2-blockers, the hazard climbed to 31 percent.

Here’s the medical connection to bone fractures: Many experts believe that by inhibiting gastric acid secretion in the gut, PPIs and other acid reducers limit calcium absorption. If the body doesn’t absorb enough calcium, it compensates by increasing a particular hormone, which results in a process that releases calcium out of the bone and into the bloodstream. In a nutshell, there isn’t enough calcium in the body anymore.

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Examining other medical options

So, for parents with babies suffering from reflux, what are some other options, other than PPIs or H-2 blockers?

“There are some dietary modifications you could try, and of course, the biggest one is simply repositioning the child,” McGeorge said. “We have survived this long without the use of proton pump inhibitors in children. I think we will continue to survive as a species.”

These suggestions that McGeorge offered are often called lifestyle changes: positioning therapy and feeding adjustments. They’re pretty simple and often effective.

For some parents like Dreffs, the medications seemed worth a shot. For others, the idea brought mixed emotions. Jennifer Hoppe Kolky, who also lives in Michigan, said that on one hand, she saw the necessity when it came to controlling her daughter’s reflux.

“She would spit up, and sometimes, it would choke her and she couldn’t breathe -- (which was) super scary,” Kolky said. “I wouldn’t say she was spitting up constantly and losing weight, but it was enough of a problem for the doctor to prescribe" the PPI.

Claire, now 3, stayed on the PPI for less than a year.

“I am not certain I liked it or not,” Kolky said. “I did research on (the) internet about (the medication). I remember not liking the fact she was on it.”

Claire’s doctor recommended an H-2 blocker at first, but Claire didn’t tolerate it well and it wasn’t effective, Kolky said.

“He referred us to specialist, who then prescribed the PPI,” Kolky said. “She prescribed lansoprazole.”

Prevacid, which Dreffs mentioned, is a brand of lansoprazole.

“Claire was on it for under one year. It worked,” Kolky said. “Eventually, we just went off of it and she was fine. Turns out, she had cow’s milk protein intolerance and that definitely played a role."

Does timing and duration matter? Study says yes

If a family doctor or pediatrician has been pushing drugs such as PPIs, just know that there does seem to be a relationship between how long these children in the study took PPIs and their risk for bone fractures.

“Those taking them for a month or less were at a 19 percent greater hazard of bone breakage than infants who did not take the suppressors,” JAMA said. “Those taking the drugs for 60 days to 150 days were at 23 percent greater hazard, and those taking them longer than 150 days were at 42 percent increased hazard.”

And although most of these drugs are easily available over the counter, “Our study adds to a growing body of evidence suggesting [acid-reducing] medications are not safe for children, especially very young children,” the author of the study said, according to JAMA.

She added, “They should only be prescribed to treat confirmed serious cases of more severe, symptomatic, GERD -- and for the shortest length of time needed.”

But in adults, PPIs are a different story. For example, PPIs are known to be effective for adult treatment of GERD or other conditions.

The drugs, which JAMA said are prescribed for about 7.8 percent of the U.S. population, have recently come under scrutiny.

“In 2010-11, they were linked to a heightened susceptibility to hip and other fractures in the elderly, prompting the FDA to issue a warning,” the report said. “This July, a report suggested that they may contribute to early death among adults, based on an analysis of 350,000 people in the U.S. Veterans Affairs database.”

Given this information, some pediatricians cited in the JAMA report said it’s worrisome that the drugs are being used to suppress something as natural in infants as GER.

Remember earlier when we mentioned GER vs. GERD?

GERD is much more corrosive -- but less than 5 percent of babies have GERD.

“Reflux (or GER) can be severe enough that it can cause other problems, but generally, reflux in an infant is just annoying,” McGeorge said. “(Although) reflux that is chronic in an adult can lead to esophageal problems long-term.”

So, the distinction is important.

What's next?

So, how do you know what to do, or who to trust, if you have a baby who spits up? What should parents make of all this information? How does one determine if it's just a case of mild reflux, or if it could continue further into childhood or adulthood?

An expert from the University of Massachusetts said in the report that she is taking a wait-and-see attitude about the study. 

“This is just one more association study. Causality remains elusive,” she said, referring to previous studies linking PPI use to bone fractures in adults and the elderly population. “But that doesn’t mean you should ignore the drumbeat. It is possible that the era of considering these to be scot-free medications where you need not worry about side effects is over.”

McGeorge concluded, “I think this is a situation where doctors are using medication because they have been encouraged to by the manufacturers, and they have a problem (which is reflux) that now has a potential solution. On the other hand, I don’t think there’s any need to treat the majority of cases of reflux.”

As always, if you're wondering about your child's unique circumstances, chat with your family doctor or pediatrician.


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