Heartburn Drug Use In Early Pregnancy Does Not Increase Birth Defect Risk

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During pregnancy, women are advised to stay away from most medications unless they have been proven safe. A new study indicates that taking a popular class of heartburn medications, called proton-pump inhibitors (PPIs), does not appear to increase the risk of birth defects when taken during the first trimester. Some physicians, though, are still cautious and recommend that women use other methods for relief.

PPI's May Increase Risk When Taken Prior to Conception

Proton-pump inhibitor medications include Prilosec (omeprazole), Prevacid (lansoprazole), Nexium (esomeprazole), Aciphex (rabeprazole), and Protonix (pantoprazole).

The study, funded by the Danish Medical Research Council and the Lundbeck Foundation and conducted at the Statens Serum Insitut in Copenhagen, used information from linked databases on about 841,000 babies born in Denmark between 1996 and 2008. Data was also collected on the babies’ mothers’ use of heartburn drugs during pregnancy. The babies were followed until they were one year old.

The use of proton-pump inhibitors for heartburn relief was highest between 2005 and 2008, when about 2% of fetuses were exposed – primarily during the last two-thirds of pregnancy. The proportion of babies with major birth defects in women who took PPI’s during the critical first trimester was only slightly increased over babies born to women who did not use the drugs – 3.2% versus 2.6%.

Read: H2 Blockers Used for Heartburn Safe in Pregnant Women

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Unfortunately, however, the researchers did find a link between PPI use before conception and the increased risk of birth defects. Among women who took the popular heartburn medications prior to becoming pregnant had a 39% increased risk of a baby born with a major birth defect. The researchers were unsure of the exact factor related to the increased risk, but suspect it could be because of the presence of Helicobacter pylori, bacteria that causes most gastric ulcers.

Physicians are appropriately cautious, however, of prescribing any medication in pregnancy as many medications have not been adequately studied for safety during this time. “In general, these are probably safe,” says Dr. Eva Pressman, professor of obstetrics and gynecology at the University of Rochester Medical Center. “But it takes a lot of time and a lot of exposure before you see some of the abnormalities that might exist.”

Read: Tips to Ease Heartburn of Pregnancy

She recommends avoiding medication when possible and trying alternative methods for heartburn relief, such as antacids like TUMS, Maalox or Mylanta which are locally acting and absorbed, reducing the risk to the fetus. Other recommendations include avoiding large meals, staying upright after eating for a period of time to promote digestion, and avoidance of foods known to cause heartburn such as spicy foods and caffeine.

Should a proton-pump inhibitor be recommended, the authors of the study found that Prilosec was the only drug not associated with increased risk of birth defects when taken prior to conception, and should be first line of treatment in women of reproductive age.

Source references:
Pasternak B, Hviid A "Use of proton-pump inhibitors in early pregnancy and the risk of birth defects" N Engl J Med 2010; 363: 2114-2123.
Mitchell AA "Proton-pump inhibitors and birth defects -- some reassurance, but more needed" N Engl J Med 2010; 363: 2161-2163.

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