Pantoprazole in Pregnancy and Breastfeeding

Risk Factor: BM
Class: Gastrointestinal agents / Antisecretory agents

Contents of this page:
Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers

Fetal Risk Summary

Pantoprazole is a proton pump inhibitor that blocks gastric acid secretion by a direct inhibitory effect on the gastric parietal cell (1). It is used in the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD).

Reproductive studies have been conducted in pregnant rats and rabbits at doses up to 88 and 16 times, respectively, the recommended human dose based on body surface area (1). No evidence was found at these doses of impaired fertility or fetal harm.

Similar to other proton pump inhibitors, pantoprazole is carcinogenic in mice and rats (gastrointestinal, liver, and thyroid) (1). The dose-related nature of the tumors and the presumable limited in utero exposure to the drug during human gestation probably indicates a negligible risk. In addition, positive results were seen with pantoprazole in the in vitro human lymphocyte chromosomal aberration assays, and in some mutagenic tests with mice, rats, and hamsters. However, negative results were obtained in the in vitro Ames mutation assay and in the mammalian cell-forward gene mutation assay, and in several other tests of mutagenicity (1).

It is not known if pantoprazole crosses the human placenta. The molecular weight (about 432 for the hydrated form) is low enough, however, that passage to the fetus should be expected. Another proton pump inhibitor, omeprazole, has a similar molecular weight (about 345) and chemical structure and it is known to cross the human placenta (see Omeprazole).

No reports describing the use of pantoprazole during human pregnancy have been located. Human pregnancy experience with two other proton pump inhibitors (see Lansoprazole and Omeprazole) have not shown a causal relationship with congenital malformations. In some cases, for both agents, malformations may have been missed because of the design and size of the studies. The animal and cell toxicity 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 pantoprazole during pregnancy, especially during the 1st trimester, is the safest course. If pantoprazole 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 pantoprazole and the published experience for other proton pump inhibitors, appears to be low. Long-term follow-up of offspring exposed during gestation is warranted.

Breast Feeding Summary

No reports describing the use of pantoprazole during human lactation have been located. Both pantoprazole and the inactive metabolites are excreted into the milk of lactating rats (1). The animal data and the relatively low molecular weight (about 432 for the hydrated form) suggest that pantoprazole excretion into human milk should be expected. Because of the carcinogenicity and mutagenicity in animals, the chromosomal aberrations in human lymphocytes, and the potential for suppression of gastric acid secretion in the nursing infant, the use of pantoprazole during lactation should probably be avoided until clinical data are available.

References

  1. Product information. Protonix. Wyeth-Ayerst Pharmaceuticals, 2001.

Index
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Questions and Answers

Effects of Long term use of pantoprazole?, Does anyone know the effects long term use of pantoprazole & other PPI's have on the body.

Can these effects just develop after a few months of use or do they only start when you begin taking the medication?

Hi:

Check outMedlinePlus below for basic info. Also, your GP can help with specific symptoms. However, an extract from Drug Digest is:

"What side effects may I notice from taking pantoprazole?
Side effects that you should report to your prescriber or health care professional as soon as possible:
•fever or sore throat
•redness, blistering, peeling or loosening of the skin, including inside the mouth
•skin rash, itching
•unusual bleeding or bruising
•unusual weakness or tiredness
•yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
•diarrhea
•dizziness
•dry skin
•headache
•nausea/vomiting
•stomach pain or gas
•tiredness

What should I watch for while taking pantoprazole?
It can take several days of therapy with pantoprazole before your stomach pains improve. Check with your prescriber or health care professional if your condition does not improve, or if it gets worse. You can take antacids for the occasional relief of stomach pain unless your prescriber or health care professional tells you otherwise."

Long term use of pantoprazole?, Does anyone know if long term use of pantoprazole & PPI's in general (almost six months) can cause constipation?

SIDE EFFECTS: Pantoprazole like other PPIs is well-tolerated. The most common side effects are diarrhea, nausea, vomiting, constipation, rash and headaches. Dizziness, nervousness, abnormal heartbeat, muscle pain, weakness, leg cramps and water retention rarely occur.

Gastritis, should i be taking pantoprazole?, The doc said i have gastritis and prescribed pantoprazole 40 mg , I've done some research and pantoprazole is a pretty strong drug (4 cases of death have been reported in older aged people) , should i be taking this for gastritis?

Pantoprazole is Protonix - a proton pump inhibitor similar to the over-the-coutner mediation Prilosec (omeprazole). It reduces acid production in the stomach and is therefore used to treat gastric ulcers and acid reflux disease (GERD).

You could potentially just as easily treat the gastritis yourself by taking over-the-counter prilosec.

But, pantoprazole is actually a very well tolerated and very safe drug.

Aspirin could be considered more dangerous...and has indirectly and directly caused more millions of more deaths than pantoprazole.

...though, aspirin is considered a very safe drug, too...if used appropriately.

Protonix is safe for pregnant women to take (a class B drug), though aspirin is not (a class D drug).

Hope this helps some...

is there a liquid pantoprazole?, I have the 40mg pantoprazole for acid reflux but pills don't go well with me I just tryed taking one major discomfort and now I feal worse then before I took it.

not at the moment but there is a recipe to make a slurry from the tablets that the pharmacists must compound

what kind of drug i have [pantoprazole]?, what is the drug pantoprazole and what is it for

Pantoprazole is used to treat gastroesophageal reflux disease, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus.

It is also used to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome.

What is PANTOLOC pantoprazole sodium?, And what are the side effets of this medicen?

IT IS PROTON PUMP INHIBITOR H2 BLOCKER CHEMICAL !USED FOR HYPERCHLORHYRIA AND ACID PEPTIC DISEASE !IT IS POTENTIALLY CARCINOGENIC IF TAKEN FOR A LONG PERIOD AND IN EXCESSIVE DOSAGE !FOR BEST RESULT IT SHOULD BE TAKEN ON EMPTY STOMACH ONCE A DAY !THOUGH GIVEN WITH MANY MEDICINES BUT IT MAY RESTRICT THE ABSORPTION OF THE MEDICINE ALSO !IT HAS SOME HYDROPHILIC EFFECT IN THE BRAIN TISSUE IF IT CROSSES THE BLOOD BRAIN BARIER !GENERALLY IT DONT HAPPEN !I KNOW ONE CASE WHO BECAME MANIAC AFTER SO LONG ON IT WITH ANTI KOCH'S TREATMENT !AWAYS YouRsmE