Nexium, Other Heartburn Drugs, Often Given To Newborns Despite Risks: Study

The findings of a new study indicates that infants are frequently given heartburn drugs, such as Nexium, Prilosec and Zantac, despite concerns about potential health risks and evidence that suggests that may be no more effective than a placebo for newborns. 

Researchers from the Ohio State University College of Medicine and Nationwide Children’s Hospital found that in recent years, nearly one in four infants were given either proton pump inhibitors (PPIs), like Nexium and Prilosec, or histamine-2 receptor antagonists (H2RAs), like Zantac. The findings were published in the May issue of The Journal of Pediatrics.

The study involved data on 122,002 infants treated at 43 children’s hospitals from January 2006 through March 2013. The data was taken from the Pediatric Health Information System database.

The study found that 23.8% of the newborns had received some type of heartburn drug, with 19% given H2RAs and 10.5% given PPIs. Infants most likely to receive the medications were those who were born extremely premature, and those with gastroesophageal reflux disease (GERD), congenital heart disease, and those with an ear, nose, and throat problem.

The findings raise concerns following several studies that have questioned whether the drugs do any good, and many have indicated they carry a risk of sometimes severe side effects.

In a 2011 report, researchers warned that the only controlled trials involving drugs like Nexium, Prilosec and Prevacid found that “PPIs have not been superior for symptom relief or histological healing” when compared to other heartburn drugs.

“In Infants with irritability or regurgitation, several randomized, placebo-controlled trials and a systematic review conclude that PPIs are no more effective than placebo in improving symptoms,” the 2011 report found.

In this latest study, the researchers warned that 56% of infants given heartburn drugs while in the hospital were still taking them at discharge. Overall, 75.7% of those given PPIs were still being given them at discharge, as well as 51.7% of those given H2RAs.

“Our investigation demonstrates H2RAs/PPIs are frequently prescribed to neonates in US children’s hospitals often to discharge, despite a lack of published evidence for improved outcomes following their administration and increasing concerns for adverse effects,” the researchers noted. “Uncomplicated gastroesophageal reflux symptoms usually resolve by 12 months of age without treatment. The few available studies in preterm infants failed to show a reduction in symptoms clinically attributed to GERD following acid suppression.”

Researchers also warned that there are concerns that gastric acid suppression could be harmful because stomach acidity in infants plays an important role in developing the defense against pathogens in the gastrointestinal tract. Previous studies have shown that H2RAs like Zantac have been linked to a higher risk of bloodstream infections in infants, they warned.

The study comes amid growing concerns over the side effects of Nexium and other PPIs.

Nexium Kidney Concerns

In addition to Nexium, PPIs include some of the most widely used brand name medications in the United States, with Prilosec, Protonix, Prevacid, Dexilant, AcipHex and other treatments part of this class of medications. PPIs work by reducing the amount of acid in the stomach and are widely used by millions of Americans, since they are thought to carry few serious side effects.

The FDA required a number of warning label changes for Nexium and other PPIs in December 2014, adding information for the first time about the risk of acute interstitial nephritis seen among users of the heartburn drugs. This condition involves inflammation that can lead to kidney injury or kidney failure if not promptly treated.

In April 2015, a study published in the medical journal CMAJ Open found that in addition to acute interstitial nephritis, Nexium and other similar drugs may also increase risk of acute kidney injury, which involves an abrupt loss of kidney function.

That research was followed by a study published earlier this year in the medical journal JAMA Internal Medicine, which found an increased risk of chronic kidney disease with use of proton pump inhibitors. That study suggested that users of Nexium, Prilosec and other heartburn drugs may face a 50% higher kidney disease risk when compared to non-users.

Last month, yet another study published in the Journal of the American Society of Nephrology, found an increased risk of kidney failure and chronic kidney disease associated with long-term use of Nexium and other PPIs.

Individuals throughout the United States are now pursuing potential Nexium lawsuits, Prilosec lawsuits and other acid reflux drug lawsuits over the kidney side effects associated with proton pump inhibitors.

Plaintiffs allege that if warnings had been provided about the risk of acute interstitial nephritis, acute kidney injury, chronic kidney injury and kidney failure, many individuals may have been able to avoid these severe and potentially life-threatening injuries.