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Proton Pump Inhibitors May Not be Safe in Pregnancy

Oct 19, 2010 | Parker Waichman LLP

Taking heartburn drugs called proton pump inhibitors during pregnancy may increase the risk of having a baby with a cardiac birth defect. This, according to a study presented at the Digestive Disease Week 2010 conference this past May.

Proton pump inhibitors, available by prescription and over-the-counter (OTC), work by reducing the amount of acid in the stomach, and are approved to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Prescription versions of the drugs include Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, and Aciphex. OTC brands include Prilosec OTC, Zegerid OTC and Prevacid 24HR. 

Since their introduction in the 90s, proton pumps have ranked among the top selling drugs, with doctors writing 119 million prescriptions for them last year alone. About half of women experience acid reflux during pregnancy, and physicians are increasingly prescribing proton pump inhibitors to treat them. The safety of the drugs in pregnancy has never been clearly established.

For the study presented at Digestive Diseases Week, researchers from the University of Pennsylvania reviewed medical records from The Health Improvement Network to identify 208,951 pregnancies in the United Kingdom from 2000 to 2008. They identified 2,445 cases of cardiac malformations in infants and 19,530 matched controls.

The study found that use of proton pump inhibitors during pregnancy was associated with a doubling in the risk of cardiac birth defects in newborns, with omeprazole (brand names Prilosec and Zegerid) associated with the highest risk of cardiac birth defects compared to the other proton pump inhibitors evaluated.

The researchers determined that proton pump inhibitor use was not associated with an increased risk of birth defects in other organs.

“We feel that our data … can have a large public health impact given the fact that GERD is so common during pregnancy,” study co-author Andrew D. Rhim, MD said during a news conference in May to announce the findings.



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