The use of common anti-reflux medications, proton pump inhibitors ( PPIs ), during pregnancy may be associated with cardiac birth defects.

More than half of all women who become pregnant suffer from gastroesophageal reflux ( GERD ), which can be hard to control during pregnancy. Often symptoms start early in pregnancy when the fetus is most vulnerable to the effects of medications, which can lead to birth defects. Because of the prevalence of GERD during pregnancy, investigators sought to determine the safety of a popular class of anti-reflux medications, proton pump inhibitors, on the developing fetus.

Usually, physicians treat pregnancy-related GERD with conservative measures such as advising patients to eat smaller meals, but frequently, these methods are ineffective, which is why physicians are increasingly prescribing PPIs. Since proton pump inhibitors are relatively new to the market, not much is known about their safety during pregnancy. For example, Omeprazole, the most commonly used PPI, is designated as a class C by FDA, which means that animal studies show adverse effects to the fetus, yet there are no adequate studies in humans since those that have been conducted had too small a sample to draw any definitive conclusions.

Researchers at University of Pennsylvania School of Medicine, performed a nested case-control study within The Health Improvement Network database and looked at medical records from pregnant women in the United Kingdom from 2000 to 2008. They identified which pregnancies resulted in birth defects and compared the maternal PPI use of these cases with matched pregnancies that did not result in a birth defect.

Researchers found that proton pump inhibitors use during pregnancy was associated with a doubling in the risk of cardiac birth defects in the newborn. The lack of association between maternal PPI use and other types of birth defects makes it less likely that our findings are due to confounding.

Cardiac birth defects associated with proton pump inhibitors use, such as ventricular septal defect and tetralogy of Fallot, are relatively rare.

Patients and physicians need to weigh the possible risks and benefits of anti-reflux treatment on a case-by-case basis, since many women will develop heartburn in pregnancy that can be severe and result in poor quality of life. Of all of the proton pump inhibitors that researchers looked at, Omeprazole was associated with the greatest increase in the risk for having a baby with a cardiac birth defect.

The data from the study suggest that H2 receptor antagonists, another anti-reflux medication that has been proven to be effective and are considered safe in pregnancy, could be tried before proton pump inhibitors to minimize potential risks. Then, if symptoms are not controlled by H2 receptor antagonists, PPIs could be considered next.

Source: DDW, 2010

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