Safety of Rabeprazole and Dexlansoprazole in Pregnancy
Both rabeprazole (Aciphex) and dexlansoprazole (Dexilant) can be used during pregnancy when clinically indicated, as proton pump inhibitors (PPIs) as a class do not represent a major teratogenic risk based on available human data.
Evidence for PPI Safety in Pregnancy
The safety profile for PPIs during pregnancy is reassuring based on multiple lines of evidence:
A large prospective controlled study of 410 pregnancies exposed to various PPIs (including omeprazole, lansoprazole, and pantoprazole) found no increased rate of major congenital anomalies compared to controls (3.6-3.9% vs 3.8% in controls), even with first-trimester exposure 1
The FDA labeling for rabeprazole indicates no available human data specifically for rabeprazole in pregnancy, but animal studies at doses 13 times (rats) and 8 times (rabbits) the human exposure showed no evidence of harm to the fetus 2
The background risk of major birth defects in the U.S. general population is 2-4%, and the PPI-exposed populations fall within this range 2, 1
Specific Considerations for Rabeprazole
Rabeprazole animal data at high doses (up to 13x human exposure) revealed no teratogenic effects during organogenesis 2
One animal study with a different PPI showed bone morphology changes in offspring when administered throughout pregnancy and lactation, but when confined to gestation only, no bone effects were observed 2
The FDA classifies rabeprazole as having insufficient human data, but animal studies are reassuring 2
Specific Considerations for Dexlansoprazole
While the provided evidence does not contain specific data on dexlansoprazole, it is a PPI in the same class as lansoprazole, which showed a 3.9% major anomaly rate (not different from controls) in the European study 1
Lansoprazole had very limited human pregnancy experience as of 2005, with only 62 pregnancies studied (55 first-trimester exposures), but outcomes were reassuring 1
Clinical Decision-Making Algorithm
When a pregnant woman requires acid suppression therapy:
Confirm the clinical indication - GERD, peptic ulcer disease, or other acid-related conditions that require treatment 1
Consider that untreated GERD is common in pregnancy and can significantly impact maternal quality of life 1
Use the PPI at the lowest effective dose - this is standard practice for all medications in pregnancy 2
Counsel the patient that the available evidence suggests PPIs do not represent a major teratogenic risk - the rate of major anomalies in exposed pregnancies is similar to the general population 1
Continue treatment throughout pregnancy if needed - there is no evidence requiring discontinuation in any specific trimester 1
Important Caveats and Common Pitfalls
Do not withhold necessary PPI therapy due to exaggerated teratogenic concerns - only approximately 20 drugs or drug groups are known to cause birth defects in humans, and PPIs are not among them 3
Avoid the trap of "uncertainty equals danger" - while definitive safety data are limited (as is true for most medications in pregnancy), the available evidence from multiple studies is reassuring 1, 3
Be aware that pregnant women often have heightened concerns about medication safety - studies show many women believe it is less safe to take medicines during pregnancy and may discontinue necessary treatments 4
Provide clear, evidence-based guidance - conflicting or unclear information increases patient anxiety and may lead to inappropriate medication discontinuation 4
Comparison to Other Acid-Suppression Options
H2-receptor antagonists (like ranitidine, though now withdrawn, or famotidine) are alternative options with longer safety track records in pregnancy 1
Antacids are generally considered safe but may be less effective for moderate to severe GERD 1
For women requiring PPI therapy before pregnancy, continuation during pregnancy is reasonable when the clinical benefit justifies use 1