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Two Studies Add Evidence to a Potential Link Between PPIs and Birth Defects

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If you're a woman and you're pregnant, likely you're no stranger to heartburn. Increased levels of certain hormones, as well as pressure from the expanding uterus, can cause stomach acids to back up into the esophagus, resulting in that painful burning in the chest.

Though some women find relief with lifestyle and dietary changes, others have more severe heartburn that is diagnosed as gastroesophageal reflux disease (GERD). These women often take a type of medication called a "proton pump inhibitor" (PPI) that helps inhibit the formation of excess stomach acid, providing relief. Unfortunately, some of these women then go on to give birth to children with birth defects. In fact, recent scientific studies have indicated a link between PPI medications and certain heart defects.

Early Studies Indicate A Potential Link Between PPIs and Birth Defects

PPI drugs were first introduced in the 1980s for the treatment of heartburn, ulcers, and GERD. Today, medications likely to be named in a birth defects lawsuit include the following:

  • Prevacid
  • Nexium
  • Prilosec
  • Aciphex
  • Protonix

One early study in 2001 of over 900 pregnancies showed that Prilosec seemed to increase the risk of congenital heart defects. Researchers were uncertain at that time, however, and noted the effects could be random. Since then, however, two additional studies have added evidence to the issue.

Denmark Study Seems to Provide Reassurances

In the November 24, 2010 issue of the New England Journal of Medicine, researchers Pasternak and Hviid analyzed data from 840,000 live births in Denmark, and found no evidence to suggest that PPIs taken during pregnancy increased the risk of birth defects overall. In the editorial of the journal, Dr. Allen A. Mitchell noted that the study may provide reassurance to prospective mothers about the safety of these drugs, but acknowledged that the data provided an incomplete overview. Mitchell went on to point out that despite the large size of the study population, it was still too small to consider the risk of specific birth defects in relation to specific PPIs, which is important to know.

One finding of possible concern in this study was that women who took PPIs in the weeks prior to conception seemed to have an increased risk of birth defects.

Second Study of PPIs Indicates Double the Risk of Cardiac Birth Defects

A second study conducted by researchers at the University of Pennsylvania provided conflicting results. Examining data from The Heath Improvement Network (THIN) database—a repository of data from general practitioners in the U.K. collected from 2000 to 2008—they analyzed PPI exposure and cardiac birth defects. Out of over 200,000 pregnancies, they found nearly 2,500 cases of heart defects, and determined that overall, maternal use of a PPI medication during the first trimester was associated with twice the risk of cardiac birth defects.

These birth defects may include ventral and atrial septal defects, in which a hole exists in one of the chambers of the heart, as well as hypoplastic left heart syndrome (underdeveloped right side of the heart), Tetralogy of Fallot (a combination of four heart defects), and a narrowing of the aorta.

Though most of the lawsuits filed against PPI medications have so far concerned bone fractures, these new studies have increased awareness of the potential connection between these drugs and birth defects. As a result, more mothers who took a PPI medication during pregnancy and then gave birth to a child with a heart or other birth defect may soon turn to a birth defects lawyer for help.