Aciphex Birth Defects

Aciphex Birth Defects May Include Heart Defects

Prescribed to treat gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and gastric ulcers, Aciphex (rabeprazole) belongs to a group of drugs known as “proton pump inhibitors (PPIs).” These drugs inhibit the production of stomach acid by blocking the enzyme in the wall of the stomach that produces that acid.

Common Aciphex side effects include headache, diarrhea, constipation, abdominal pain, nausea, and rash. High doses and long-term use have also been linked with fractures of the hip, wrist, and spine. Until recently, however, Aciphex birth defects seemed a non-issue. The drug has been designated as FDA Category B, which means that animal studies have failed to show a risk of birth defects, and no well-controlled studies exist in pregnant women. New scientific studies, however, may soon challenge that categorization.

What is a Proton Pump Inhibitor (PPI)?

Proton pump inhibitors (PPIs)—which include Aciphex and other brands like Dexilant, Prevacid, Prilosec, Protonix, Nexium, and Zegarid—help reduce stomach acid by blocking the enzyme that produces it, thus helping to prevent ulcers, while giving those that may already exist in the esophagus, stomach, and the first part of the intestine time to heal. They also may be used in combination with antibiotics to help kill Helicobacter pylori, bacteria that combine with stomach acid to cause ulcers.

Aciphex Birth Defects: Some Studies Show a Link

About 25 percent of pregnant women experience acid reflux, with half of them suffering from it during the last trimester. The additional hormones circulating in the body plus the extra pressure on the stomach both serve to increase the amount of stomach acid. In addition to being uncomfortable, recurrent acid reflux can damage the esophagus, so women frequently seek treatment. Many are prescribed a PPI like Aciphex.

In August 2010, however, researchers reported that using a PPI during early pregnancy could double a mother’s risk of giving birth to a baby with heart birth defects such as ventricular septal defect (hole in the wall between the right and left ventricles of the heart). Scientists at the University of Pennsylvania examined data from The Health Improvement Network (THIN) database, looking at over 200,000 pregnancies, out of which nearly 2,500 resulted in babies with heart defects. They found that mothers who took a PPI during the first trimester had two times the risk of having a baby with cardiac defects.

Additional Studies Raise Questions about Aciphex Birth Defects

A second study published November 25, 2010 in the New England Journal of Medicine seemed to contradict these earlier results, with researchers concluding that the use of a PPI in early pregnancy did not significantly increase risk of birth defects, but they did find something else concerning—women who took a PPI in the four weeks leading up to pregnancy, but not during pregnancy, had a greater risk of giving birth to a child with birth defects. Researchers also noted limitations in the study, and encouraged additional research, stating that the current results were “far from definitive.”

An Aciphex Lawyer May be Able to Help

If your child was born with a birth defect, particularly a septal heart defect, and you took Aciphex either before or during your pregnancy, an Aciphex lawyer can help determine the potential for your claim in an Aciphex lawsuit. Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.