Babies have been crying and spitting up since time immemorial. But these days many parents ask: Isn't there a drug for that?
"Parents come in often demanding medication," says Eric Hassall, a pediatric gastroenterologist at Sutter Pacific Medical Foundation in San Francisco.
Prescriptions for acid-suppressing medicines for infants have increased dramatically. Hassall says some parents have picked up on the idea that heavily advertised medicines for reflux in adults can help fussy babies who spit up a lot.
He documented a 16-fold increase in prescriptions of one proton pump inhibitor, or PPI, Prevacid, which comes in a child-friendly formulation. A Food and Drug Administration review also found an 11-fold increase in number of new prescriptions dispensed between 2002 and 2009.
These medicines aren't approved for infants with reflux, or GERD. Still, some doctors have been prescribing them off-label anyway. Doctors generally agree this practice is OK when babies really need the medicine, such as when they're spitting up so much that they're not gaining weight.
"The great majority of infants spit up and cry," says Hassall. "But very, very few of them actually have reflux disease and deserve medication." Hassall has researched the effectiveness of the drugs and has received clinical study grants from AstraZeneca, the maker of the popular acid-suppressing medicine Nexium.
The results of four clinical trials show that these medicines work no better than a placebo in treating infants with reflux. "My point is that there hasn't been a sudden 16-fold increase in the incidence of reflux disease," says Hassall. "It hasn't suddenly become the scourge of otherwise healthy infants."
Hassall recommends dietary changes to the parents of inconsolable babies who spit up after feedings. This strategy has helped many of his patients, including Tara Cree of Vancouver, British Columbia, who had a rough go with her daughter.
"She was incredibly irritable," recalls Cree. "There was a lot of crying and it just didn't seem right."
The worst of it came just after breast-feedings. When she described the symptoms to Hassall, he told Cree to change her diet to remove certain proteins from her breast milk.
"I eliminated dairy, soy and wheat from my diet," Cree says. It was a radical change, since almost all processed foods include some dairy, soy or wheat. But she stuck with it because it was so effective. "By day 3 or 4 [of the diet] she was a different baby," says Cree.
Now, not every baby will get the same relief from a mother's diet change, or by switching to a nondairy baby formula. But Hassall says it's a good approach to try before turning to medication.
Specialists in pediatric gastroenterology have guidelines to help educate pediatricians and families on the treatment of reflux. "There are infants who do benefit from these drugs," says Benjamin Gold, a gastroenterologist in Atlanta, who has been a paid consultant to AstraZeneca. "It's a small proportion," he says.
But he says with all the discussion about the escalation in prescriptions, he doesn't want parents to get the wrong message. "We have to be careful that we don't swing the pendulum back the other way by saying, 'Oh, these drugs are all bad.' "
Gold says what's needed are better diagnostic tools to determine which babies truly need the medicine — and that will require more research. For now, he says, sometimes you have to try a baby on the medicine.
"The problem is we can't determine [in advance] which children are going to benefit and which are not," Gold says.
Advisers to the FDA have been looking at this issue. They say the limited data in infants suggest that the medicines are fairly safe, but there are reports of intestinal inflammation, and one study found a slightly increased risk of pneumonia.
The upshot, according to the their review, is that the medicines should be reserved for infants who've been diagnosed with serous problems, such as erosive esophagitis — a condition that afflicts relatively few babies.
RENEE MONTAGNE, HOST:
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Today in Your Health, vaccinating boys against HPV, the virus linked to cervical cancer. We'll hear why that is not as controversial as vaccinating teenage girls.
MONTAGNE: Let's turn first to a different concern - babies who cry and spit up a lot. More and more are getting prescription drugs, drugs used to treat reflux in infants. NPR's Allison Aubrey reports on why a few doctors are pushing back.
ALLISON AUBREY, BYLINE: Babies have been crying and spitting up from time immemorial. But now it turns out parents of really fussy infants are increasingly asking, isn't there medicine for this?
DR. ERIC HASSALL: Parents come in often demanding medication. And if they don't get it from one physician, they often will get it from another.
AUBREY: That's Dr. Eric Hassall, a specialist who has long treated children with stomach problems. He says some parents have picked up on the idea that heavily advertised medicines for reflux can help.
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AUBREY: Now, these medicines are not approved for infants with reflux. Doctors have been prescribing them off-label, and Hassall says this practice is fine in cases when babies are very sick. For instance, when they're spitting up so much they're not gaining weight.
HASSALL: The great majority of infants spit up and they cry, but very, very few of them actually have reflux disease and deserve medication.
AUBREY: In fact, four clinical trials show that these medicines work no better than a placebo pill - or sugar pill - in treating infants with reflux. And yet prescriptions for these drugs have shot up significantly. One study documented a 16-fold increase in prescriptions for one acid suppressing medication, which is sold in a child-friendly formulation.
HASSALL: There hasn't been a sudden 16-fold increase in the incidence of reflux disease. It hasn't suddenly become the scourge of otherwise healthy infants.
AUBREY: So what does Hassall recommend when the parents of inconsolable babies who are spitting up all the time come in for help? Well, one of his patients is Tara Cree, who was at her wit's end with her infant daughter.
TARA CREE: She was spitting up a lot, crying. It just didn't seem right. She was incredibly irritable.
AUBREY: The worst of it came just after breast-feedings. When she described these symptoms to Hassall, he told Tara to change her diet to remove certain protein from her breast-milk.
CREE: He said I'm going to suggest that you try elimination of certain foods and it's often the cause of reflux. So I eliminated dairy, soy and wheat from my diet.
AUBREY: Cree says it was a radical change. But she says right away her daughter's symptoms started to improve.
CREE: Two days of me eliminating that from diet that I started to see a positive impact and by day three or four she was a different baby.
AUBREY: Now, not every baby will get the same relief from a mother's diet change or by switching to a non-dairy baby formula, though Hassall says he usually starts with this approach, so he doesn't need to use medicine.
But not all doctors are on the same page on this issue. Pediatric gastroenterologist Benjamin Gold says prescriptions for infants may have escalated, but he says he doesn't want parents to be left with the wrong message.
DR. BENJAMIN GOLD: There are infants who do benefit from the drugs. And yes, it's a small proportion of the spitty, irritable, fussy babies. But we have to be careful that we don't swing the pendulum back the other way by saying, oh, these drugs are all bad.
AUBREY: Gold says what's needed are better diagnostic tools to determine which babies truly need the medicine. And this requires more research. For now, he says, sometimes you have to try a baby on the medicine.
GOLD: The problem is that right now we are not able to clearly determine which children are going to benefit and which aren't.
AUBREY: Advisors to the Food and Drug Administration have been looking at this issue. They say the limited data in infants suggests the medicines are fairly safe, but there are reports of intestinal inflammation and one study found an increased risk of pneumonia. FDA advisors say given the evidence that the medicines are not effective in treating babies with reflux, prescriptions should be reserved for infants who've been diagnosed with problems such as erosive esophagitis, a serious condition that afflicts relatively few babies.
Allison Aubrey, NPR News. Transcript provided by NPR, Copyright NPR.