R



R



RABEPRAZOLE


Gastrointestinal Agent (Antisecretory)


PREGNANCY RECOMMENDATION: Limited Human Data—Animal Data Suggest Low Risk


BREASTFEEDING RECOMMENDATION: No Human Data—Potential Toxicity



PREGNANCY SUMMARY


No reports describing the use of rabeprazole during human pregnancy have been located. A study showing an association between in utero exposure to gastric acid–suppressing drugs and childhood allergy and asthma requires confirmation. Human pregnancy experience with three other proton pump inhibitors (PPIs) (see Lansoprazole, Omeprazole, and Pantoprazole) has not shown a causal relationship with congenital malformations. In some cases, malformations may have been missed because of the design and size of the studies. The carcinogenic and mutagenic data are a potential concern, but the absence of follow-up studies prevents a risk assessment for exposed offspring. As with all drug therapy, avoidance of rabeprazole during pregnancy, especially during the 1st trimester, is the safest course. If rabeprazole is required or if inadvertent exposure does occur early in gestation, the known risk to the embryo–fetus for congenital defects, based on animal data for rabeprazole and the published experience with other PPIs, appears to be low. Long-term follow-up of offspring exposed during gestation is warranted.


FETAL RISK SUMMARY


Rabeprazole is a PPI that blocks gastric acid secretion by a direct inhibitory effect on the gastric parietal cell (1). It is used for the treatment of duodenal ulcer, erosive or ulcerative gastroesophageal reflux disease (GERD), and the long-term treatment of pathologic hypersecretory conditions, such as Zollinger-Ellison syndrome. Rabeprazole is in the same class of PPIs as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, and pantoprazole.


Reproductive studies have been conducted in rats and rabbits with IV doses up to 13 and 8 times, respectively, the recommended human dose based on AUC (1). No evidence was found at these doses of impaired fertility or fetal harm. In male and female rats, rabeprazole caused gastric cell hyperplasia and, in female rats, gastric cell tumors, at all doses tested (1). In addition, positive results with the drug and its inactive metabolite were demonstrated in hamsters and mice with the in vitro Ames mutation assay and in some other mutagenicity tests (1).


It is not known if rabeprazole crosses the human placenta. The molecular weight (about 381 for the sodium salt) is low enough that passage to the fetus should be expected. Another PPI, omeprazole, has a similar molecular weight and chemical structure and it is known to cross the human placenta (see Omeprazole).


A population-based observational cohort study formed by linking data from three Swedish national health care registers over a 10-year period (1995–2004) was reported in 2009 (2

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Jul 24, 2016 | Posted by in GYNECOLOGY | Comments Off on R

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