Pregnancy brings about a lot of heartburn sometimes beginning in the first trimester and continuing until delivery. To date the drugs available for general use in heartburn called proton-pump inhibitors or PPIs were wrought with safety concerns during pregnancy.
In a new study it is shown that these drugs, especially Prilosec, appear to be safe for pregnant women and women who may become pregnant. The researcher team in Denmark examined a database that showed 5,082 cases in women who were exposed to proton-pump inhibitors at some time during the period of four weeks prior to pregnancy through the first trimester. Results showed that there was no significant differences in birth defects among the women who took PPIs compared with the women who did not. 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.
However during the four weeks prior to pregnancy exposure to PPIs except Prilosec, or Omeprazole, increased the risk of major birth defects by 39%. However authors feel that this result is absurd since the drug des not stay in the body for more than a few hours. But the risk of pre-pregnancy exposure cannot be ruled out, said the authors of an accompanying editorial. They write an underlying condition that requires use of the medications may increase the risk of birth defects or that the medications cause sustained changes in micronutrients that raise the risk of birth defects.
The paper was published in the acclaimed New England Journal of Medicine this Wednesday. The authors write, “Until we have a better understanding of what might explain this latter finding [an increased risk prior to conception], it may be prudent to consider omeprazole to be the PPI of choice when PPI treatment is clearly needed for women of childbearing potential and particularly for those who are planning to become pregnant.”
Dr. Eva Pressman, professor of obstetrics and gynaecology and director of maternal-foetal medicine at the University of Rochester Medical Center who was not a part of the study team explains, “In general, these are probably safe but it takes a lot of time and a lot of exposures before you see some of the abnormalities that might exist…My recommendations are always to avoid medication exposure if at all possible. There are very few life-threatening disorders that require these PPIs…There are other ways to get the same effect…Most pregnant women have heartburn but most of it is relatively easy to treat with simple antacids such as Tums and Maalox and Mylanta, all of which are locally acting and absorbed, and don’t pose any risk to the foetus.” Dr. Michael Katz, senior vice president for research and global programs at the March of Dimes added that eating while one is propped up instead of lying flat can also help. He added, “Having negative observations is never absolutely reassuring… All you can say is that within that range [in this case, 800,000 infants, the probability is that it is safe… The balance in pragmatic terms is how important is it to treat the symptoms that any drug is designed to treat versus the safety of pregnancy… That’s a very difficult decision to make.”
This study was funded by the Danish Medical Research Council and the Lundbeck Foundation.
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