Proton Pump Inhibitors in Pregnancy Require Caution

An editorial in the New England Journal of Medicine (NEJM) asserts that <"">proton pump inhibitors should be used with caution by pregnant women. Though recent studies indicate the popular acid reducers may be safely used during pregnancy, the author of the editorial says findings on a link between proton pump inhibitors and birth defects so far have been “far from definitive.”

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. Yet the safety of the drugs in pregnancy has never been clearly established.

A study published this month in the NEJM is just the latest to provide reassuring data about the safety of proton pump inhibitors in pregnancy. It looked at more than 840,000 live births in Denmark between 1996 and 2008. The exposure to the proton pump inhibitors ranged from four weeks before conception to the end of the first trimester of pregnancy. Of the women who took proton pump inhibitors, 3.4 percent had infants who had major birth defects; in the women who didn’t take the drugs, 2.6 percent of infants did.

The researchers did, however, find an unexpected, slight increase in the risk of developing birth defects in women taking proton pump inhibitors other than Prilosec in the period right before conception.

In his accompanying editorial, Dr. Allen Mitchell, an epidemiologist from Boston University School of Medicine, calls this new study reassuring, but not definitive. Both Mitchell and the authors of the NEJM study agree it provides only a broad and incomplete overview of the most common proton pump inhibitors (Prilosec, Prevacid and Nexium). Mitchell points out that specific medications in a class of drugs can have different risks for birth defects. More data is needed, he writes, in order to be confident that proton pump inhibitors are truly safe in pregnancy.

Mitchell also writes that additional studies are needed to reinforce the study’s observation that Prilosec might be the safest proton pump inhibitor for pregnant women.

“It may be prudent to consider omeprazole (Prilosec) to be the PPI (proton pump inhibitor) of choice when PPI treatment is clearly needed for women of childbearing potential and particularly for those who are planning to become pregnant,” he wrote in the editorial.

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