Prevacid, a medication that reduces the amount of acid made by stomach lining cells, can alleviate problems caused by esophageal reflux. The effectiveness of Prevacid in infants, however, has not been established, and the medication is not approved for use in anyone younger than 1 year of age. Because of this, information on side effects in young babies is limited, although research shows that Prevacid use might cause some intestinal or respiratory problems in infants, and some short-term effects on liver enzyme levels in the blood.
A paper published in 2008 in the journal "Pediatric Drugs" evaluated two clinical trials that studied the safety and usefulness of Prevacid in infants younger than 1 year old who experienced GERD. The studies included 28 newborns, with an average age of about 4 weeks, and 28 infants aged about 24 weeks; their symptoms included excessive regurgitation and vomiting after feeding. After five days of treatment, 58 percent of the babies experienced adverse side effects, but the investigators concluded that only a few of these were related to use of Prevacid. These included one infant who developed anemia, or a low red blood cell count, one who showed flushing of the skin, and one with an elevated liver enzyme. These were short-term studies, however, and did not address any side effects of long-term use of Prevacid.
In another clinical trial published in the April 2009 issue of the "Journal of Pediatrics," researchers studied a group of 162 infants with GERD who were treated with Prevacid or a placebo for four weeks. They found that side effects occurred more often in the treated babies than in the placebo group, with upper respiratory tract and lung infections the most common; 5 percent of infants in the treated group developed these problems, compared to 1 percent in the placebo group. Five infants given the drug also developed elevated levels of alkaline phosphatase, a liver enzyme, but this resolved several weeks after the end of treatment.
An article that appeared in the September 2013 issue of "Pharmacotherapy" assessed several clinical trials that addressed the usefulness and safety of Prevacid in children and infants. The authors of that paper concluded that Prevacid may have some benefit for infants, though it also increases the risk of respiratory and intestinal infections. In children, it could also raise risk of bone fractures by changing the body's balance of calcium and magnesium, but there are no data about this effect in infants.
What To Do
Symptoms of GERD in infants differ from those in adults, and usually include irritability or arching of the back, especially after feeding, and weight loss or a failure to gain weight. If your baby displays any symptoms of gastroesophageal reflux, see your pediatrician. Although the U.S. Federal Drug Administration has not approved use of Prevacid in infants, your doctor might recommend the drug. If so, discuss its possible side effects to decide if it is a good choice for your baby.
- National Digestive Diseases Clearinghouse: Gastroesophageal Reflux (GER) and Gastroesophageal Refulxu Disease (GERD) in Infants
- Journal of Pediatrics: Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial Assessing the Efficacy and Safety of Proton Pump Inhibitor Lansoprazole in Infants with Symptoms of Gastroesophageal Reflux Disease
- Drugs.com: Prevacid
- Pediatric Drugs: Safety and Pharmacodynamics of Lansoprazole in Patients with Gastroesophageal Reflux Disese Aged <1 Year
- U.S. Federal Drug Administration: Highlights of Prescribing Information -- Prevacid
- U.S. Federal Drug Administration Office of Pharmacological Review: Prevacid
- Pharmacotherapy: Efficacy and Safety of Proton Pump Inhibitors in the Management of Pediatric Gastroesophageal Reflux Disease