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No Link Between Heartburn Drugs and Birth Defects: Study
Date:11/25/2010

o glean information on almost 841,000 babies born in Denmark from 1996 through 2008, as well as on the babies' mothers' use of PPIs during pregnancy.

PPI use by expectant women was the highest between 2005 and 2008, when about 2 percent of fetuses were exposed, but exposure during the critical first trimester was less than 1 percent.

Babies were followed until they were one year old.

The proportion of babies with birth defects hovered at about 3 percent in both groups -- 3.4 percent of those who had been exposed to a PPI in utero, and 2.6 percent for unexposed babies.

In an unexpected finding, there was a 39 percent increased risk of major birth defects among children whose mothers had taken PPIs in the month before conception, a finding the authors are attributing to either chance or to another factor, perhaps the reason the mother was taking the medication in the first place. This could have been infection with Helicobacter pylori, the bacteria that causes most ulcers.

In addition to Prilosec, Prevacid and Nexium, the authors also looked at Aciphex (rabeprazole) and Protonix (pantoprazole).

Prilosec was the only drug not associated with an increase in birth defects when taken during the month before conception, leading the editorial author to suggest this drug as a first line of treatment.

A related journal editorial, written by Dr. Allen A. Mitchell, director of the Slone Epidemiology Center at Boston University School of Medicine, also noted some caveats. These included the fact that even this big of a sample may not have been large enough to detect specific birth defects (such as heart defects) or to ascertain the effect of specific drugs within the class. Nor can the influence of other factors be ruled out, Mitchell wrote. Perhaps folic-acid supplementation during pregnancy is hiding the true effects of the PPIs, Mitchell said.

The bottom line, according to the experts, is that it's still no
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