- Pantoprazole Pregnancy and Breastfeeding Warnings
- Pantoprazole Pregnancy Warnings
- Pantoprazole Breastfeeding Warnings
- Further information
- Parents May Recover Damages in a Protonix Lawsuit
- Protonix Lawsuit Requires Adequate Medical Records
- Evidence for Protonix Birth Defects
- A Protonix Birth Defects Lawyer May be Able to Help
- Pregnant women should take acid inhibitors with caution
- What medications are safe and effective for heartburn during pregnancy?
- What is Protonix?
- Important Information
- Before taking this medicine
- How should I use Protonix?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while using Protonix?
- Protonix side effects
- What other drugs will affect Protonix?
- More about Protonix (pantoprazole)
Pantoprazole is a prescription drug used as a short-term treatment for gastroesophageal reflux disease (GERD).
It’s part of a class of medications known as proton-pump inhibitors (PPIs) and is marketed under the brand name Protonix.
GERD is a condition in which the backward flow of acid from the stomach causes heartburn and sometimes injury of the esophagus.
PPIs such as pantoprazole work by blocking the production of acid made in the stomach.
Pantoprazole may also be used for a longer period of time for maintenance or healing of erosive esophagitis, and to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome.
Pantoprazole was originally approved by the Food and Drug Administration (FDA) in 2000 and is manufactured by the pharmaceutical company Pfizer.
In 2013, Teva Pharmaceutical Industries Ltd. (TEVA) and Sun Pharmaceutical Industries Ltd. were ordered to pay $2.15 billion to Pfizer as a settlement for unauthorized sales of pantoprazole.
Pantoprazole shouldn’t be used for the immediate relief of heartburn symptoms.
Don’t take pantoprazole if you’re allergic to any other benzimidazole medications such as albendazole (Albenza) or mebendazole (Vermox).
Long-term use of pantoprazole may make it harder for your body to absorb vitamin B-12, which could result in a B-12 deficiency.
PPI use may also increase your risk for fractures in your wrists, hips, or spine. In 2010, however, the FDA decided that there was not enough evidence of fracture risk to merit a warning.
Extended use of pantoprazole has been shown to cause stomach cancer in animal studies, but researchers are unsure if the medication has the same effects in humans.
Pantoprazole may be used in children five years of age and older for up to eight weeks to heal acid-related damage to the esophagus. It’s not known if the drug is safe for longer than eight weeks of use in children.
Tell your doctor if you are allergic to any of the ingredients in pantoprazole. You can ask your pharmacist for a list of the ingredients.
Pantoprazole and Magnesium
Low magnesium levels can also occur in people on pantoprazole for at least three months.
Tell your doctor if you have ever had low magnesium in your blood or if you have ever tested positive for the bacteria H. pylori.
Low magnesium levels can result in serious adverse events such as:
- Muscle spasms
- Irregular heartbeat
If you have low magnesium levels while using pantoprazole, your doctor may advise you to take a magnesium supplement or discontinue treatment.
Pantoprazole and Pregnancy
Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding before taking pantoprazole.
Although there is no evidence suggesting that pantoprazole use is harmful during pregnancy, it’s recommended that the drug only be used during pregnancy as needed, when no other options are available.
Research indicates that pantoprazole and its metabolites are excreted in the milk of rats, and that they may be excreted in human breast milk as well.
The manufacturer recommends that due to the potential for serious adverse reactions in breastfeeding infants, mothers using pantoprazole may want to discontinue breastfeeding or discontinue use of the drug.
Pantoprazole Pregnancy and Breastfeeding Warnings
Pantoprazole is also known as: Protonix, Protonix IV
Medically reviewed by Drugs.com. Last updated on Jun 26, 2018.
- Side Effects
Pantoprazole Pregnancy Warnings
Animal models have revealed evidence of changes to femur bone length and weight when given during gestation day 6 through lactation day 21. There are no controlled data in human pregnancy.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk.
-Some experts state that this drug should not be used in pregnancy.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.
Risk summary: Observational studies indicate that an association of major malformations or adverse events with use of this drug during pregnancy; however, drug-associated risks cannot definitively be established or excluded by observational studies due to methodological limitations.
Pantoprazole Breastfeeding Warnings
Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Yes (oral); Unknown (parenteral)
Excreted into animal milk: Yes (parenteral)
Comment: The effects in the nursing infant are unknown.
Animal models have evidence of decreased pup weight at doses of at least 10 mg/kg/day. There have been reports of excretion into human breast milk.
References for pregnancy information
References for breastfeeding information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
A multicentre prospective cohort study conducted by Motherisk looked at the outcomes among 113 mothers exposed to omeprazole during pregnancy, including 101 mothers exposed during organogenesis.3 Two control groups were used: a disease-paired control group using histamine H2-blockers and a control group of healthy women exposed to nonteratogenic medications. The rate of major malformations in the omeprazole group (5%) did not differ significantly from rates in the nonteratogenic drug control group (3%) and in the disease-paired control group (3%). Rates of spontaneous abortions, preterm deliveries, cesarean sections, and neonatal health problems; birth weight; and gestational age at delivery were also comparable in the 3 groups.
The Motherisk Program also conducted a meta-analysis on use of PPIs during pregnancy.4 All exposures to PPIs (593 cases) had a relative risk of 1.18 (95% confidence interval 0.72 to 1.94) and exposures to omeprazole only (534 cases) had a relative risk of 1.05 (95% CI 0.59 to 1.85), indicating no increase in risk of malformations.
A large cohort study from the Swedish Medical Birth Registry reported on 955 infants whose mothers used omeprazole during pregnancy.5 In this report, 863 of the infants were exposed at least during the first trimester, and 92 were exposed only after the first trimester. Birth weights, rates of congenital malformations and perinatal death, and low Apgar scores in the exposed group were comparable to rates observed in the general Swedish population.
A recent multicentre, prospective controlled cohort study followed 295 pregnancies where mothers were exposed to omeprazole (233 exposed during the first trimester), 62 pregnancies where mothers were exposed to lansoprazole, and 53 pregnancies where mothers were exposed to pantoprazole. The pregnancy outcomes of these mothers were compared with those of 868 control subjects.6 In the omeprazole group, 3.6% (9/249) of babies were born with malformations, a rate similar to the 3.8% (30/792) observed in the control group. There was no pattern of anomalies among the babies born with birth defects.
Administration of oral omeprazole to a 41-year-old woman during the third trimester of pregnancy, after ranitidine and cisapride failed to control her refractory gastroesophageal reflux disorder, was reported.7 No adverse fetal effects were apparent, and the patient elected to continue omeprazole therapy (20 mg/d) while breastfeeding. Peak omeprazole concentrations in breast milk of 58 nM at 3 hours after ingestion of the drug were lower than 7% of the peak maternal serum concentration (950 nM at 4 h), indicating limited excretion into milk.
Parents May Recover Damages in a Protonix Lawsuit
Protonix is a gastrointestinal drug known as a proton pump inhibitor (PPI), which works by reducing the amount of acid produced by the stomach. Doctors prescribe Protonix (pantoprazole) for the short-term treatment of gastroesophageal reflux disease (GERD), because it may help ease the erosion and ulceration of the esophagus and to promote healing. It may also be used for long-term maintenance treatment of GERD, and for other acid-related conditions like Zollinger-Ellison syndrome and peptic ulcer disease.
Many pregnant women experience GERD during pregnancy, and therefore may be prescribed Protonix. Unfortunately, recent studies and reports indicate that Protonix and other PPI drugs may increase the risk for Protonix birth defects. Some parents who have had babies born with Protonix birth defects have gone on to file a Protonix lawsuit in the hopes of recovering damages to pay for medical expenses.
Protonix Lawsuit Requires Adequate Medical Records
Parents considering a potential Protonix lawsuit will want to gather medical records showing when the mother was prescribed Protonix, how often she filled the prescription, how long she took the medication, and what dosage she was prescribed. A Protonix lawyer may also require medical records of the pregnancy, and a doctor’s opinion on the alleged Protonix birth defects. Medical records and receipts of all medical care required for the newborn are also important in a Protonix lawsuit.
Drug Linked to Protonix Bone Fractures
PPI drugs like Protonix have been linked to serious side effects like Protonix bone fractures of the hip, wrist, and spine. The risk for these Protonix bone fractures is greatest in those patients who are 50 years and older. In 2010, the FDA warned the public and healthcare professionals thast certain antacid drugs like Protonix may increase the risk of these fractures. The FDA released this information after reviewing seven published studies, six of which reported an increased risk of fractures of the wrist, hip, and spine. The FDA also required manufacturers of these drugs to include warnings about bone fractures on the product labels.
Evidence for Protonix Birth Defects
Though the FDA has not yet warned of Protonix birth defects, early studies indicate a connection between PPI drugs and Protonix birth defects like septal heart defects. A study published in Gastroenterology in 2010, for example, found that those mothers taking PPI drugs during the first trimester had an increased risk of giving birth to a baby with Protonix birth defects. Another 2010 study found that mothers taking PPI drugs before conception were also at an increased risk of Protonix birth defects.
A Protonix lawsuit may involve the review of these and other studies which have indicated a potential connection with Protonix birth defects like septal heart defects, limb malformations, anencephaly, and hydroencephaly.
A Protonix Birth Defects Lawyer May be Able to Help
Parents who have had a child with Protonix birth defects or Protonix birth defects may be eligible for a Protonix lawsuit. If you or a loved one has been injured by Protonix or have had a child with Protonix birth defects, contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.
Pregnant women should take acid inhibitors with caution
Pregnant women who take acid-suppressing medications called proton-pump inhibitors are not at an increased risk of having babies with birth defects, according to a study published in the New England Journal of Medicine. However, an epidemiologist from Boston University School of Medicine, in an accompanying editorial, calls the results “reassuring” but “far from definitive.”
“There’s no evidence that they do any harm, but we don’t yet have as much safety evidence as we would like,” said Boston University’s Dr. Allen Mitchell. “Unlike experimental studies, a single observational study can’t provide definitive results.”
Previous smaller studies, including one published in the American Journal of Gastroenterology in 2009, suggested that these drugs can be used safely while a woman is pregnant.
This NEJM study is the largest to date and included more than 840,000 live births in Denmark between 1996 and 2008. The exposure to the proton pump inhibitors ranged from four weeks before conception to the end of the first trimester of pregnancy. The study also included other information such as the history of birth defects in siblings, the mother’s use of certain other classes of drugs, smoking status and age at conception. The researchers did not study the reasons why the women were on the medications, nor the use of folic acid, which is widely recognized as playing a role in preventing birth defects.
Proton pump inhibitors are available by prescription and over-the-counter and are taken for symptoms of gastroesophageal reflux or heartburn. The American College of Gastroenterology says symptoms, including discomfort behind the breast bone, a “sour” stomach or pain in the upper abdomen or chest, often are resolved in pregnant women after they give birth.
In the study, of the women who took proton pump inhibitors, 3.4 percent had infants who had major birth defects; in the women who didn’t take the drugs, 2.6 percent of infants did.
Mitchell agrees with the study authors that these data provide only a broad and incomplete overview of the most common proton pump inhibitors (omeprazole, lansoprazole and esomeprazole, sold as Prilosec, Prevacid and Nexium, respectively.)
“We know that specific medications in the same group can have different risks for birth defects, so we need more data about specific drugs in relation to specific birth defects,” he said, in order to be sufficiently confident about the safety of the drug.
Mitchell pointed to two examples in particular. According to the March of Dimes, pregnant women taking the drug thalidomide in Europe, Canada and other places in the 1950s and 1960s often gave birth to children with missing or shortened limbs. In addition, the drug Accutane has been linked with brain and heart defects.
He stresses that the proton pump inhibitors do not have devastating effects on the fetus as these drugs did, but said that if a pregnant woman believes she needs a proton pump inhibitor, she should talk to her physician first.
“A woman with a chronic gastrointestinal condition who is already on PPIs and who plans to get pregnant should discuss with her doctor any potential risks associated with both her condition and with her medication. Those without chronic conditions and who get pregnancy-associated gastroesophageal reflux, and who are about to take PPI, can take them with confidence that these drugs are not associated with increased risk of birth defects on aggregate,” said study author Dr. Bjorn Pasternak.
The researchers found an unexpected, slight increase in the risk of developing birth defects in women taking proton pump inhibitors other than omeprazole in the period right before conception. But Mitchell says additional studies are needed to study this observation further.
“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,” he wrote in the editorial.
What medications are safe and effective for heartburn during pregnancy?
Ranitidine is the best-studied agent effective for treatment of heartburn in pregnancy. Some antacids are effective, but it may be prudent to avoid them in the first trimester until better safety studies are published. Although sucralfate, metoclopromide, and the proton pump inhibitors are probably safe in pregnancy, there are no data about their efficacy. (Grade of Recommendation: B )
Recommendations from others
Standard texts suggest that antacids1 or histamine (H2) blockers2 be used as first-line agents for reflux. Burrow and Duffyz3 recommend a stratified approach with antacids followed by H2-blockers, reserving the use of proton pump inhibitors for the more severe cases.
Heartburn affects 30% to 50% of pregnancies and occurs primarily in the second and third trimesters.4 Lifestyle changes and dietary modification are recommended as initial measures for relief of symptoms.
Each of the 3 identified placebo-controlled trials of antacid therapy had significant methodologic limitations. Aluminum phosphate more frequently produced complete relief of moderate to severe heartburn at 60 minutes compared with placebo (P <.001; number needed to treat = 2.1 for mild heartburn and 20 for severe).5 Patients who received a combination of magnesium and aluminum hydroxide for 7 days had no more relief of symptoms than the placebo group.6 Atlay and colleagues7 found that sodium bicarbonate significantly reduced reflux symptoms compared with placebo (P=.021; NNT=6.0).
There are limited data regarding the safety of antacids during pregnancy. A single case-control study found a higher rate of congenital anomalies in children of women who took antacids in the first trimester (unadjusted odds ratio calculated from data=2.36; P <.05).8 This association was not detected when studied over the entire pregnancy. The rate of malformations was not different for magnesium, aluminum, and bicarbonate. The association could well be due to recall bias or other systematic biases inherent in case-control methodology.
The only identified studies of H2-blockers evaluated ranitidine. A 4-week double-blind randomized control trial found that ranitidine 150 mg twice daily reduced patient symptoms by 44% over placebo (P <.05).9 This study was limited by its short duration (<1 month) and small sample size (N=30). A 2-week study that compared antacids plus ranitidine to antacids alone found a 52% decrease in symptoms in the ranitidine group and a 44% reduction in the antacid-alone group.10 Ranitidine, cimetidine, and famotidine are US Food and Drug Administration (FDA) pregnancy category B (no demonstrated risk).
Proton Pump Inhibitors
In nonpregnant adults, proton pump inhibitors are more effective than antacids and H2-blockers for gastroesophageal reflux disease (GERD). No cohort or control studies have been performed on their efficacy in pregnancy. On the basis of animal studies, omeprazole is a category C drug (potential benefit of use should outweigh potential risks). A cohort study of 113 women found no associated anomalies (relative risk=1.94; 95% confidence interval, 0.36-10.36).11 Pantoprazole, lansoprazole and rabeprazole are category B medications.
Metoclopramide and sucralfate have been used in nonpregnant adults with GERD. Although both are category B, there are no data about their effectiveness for heartburn during pregnancy.
Donald N. Marquardt, PhD, MD
Iowa Health Physicians Cedar Rapids
Heartburn along with morning sickness and back pain frequently diminishes the joy of pregnancy. Simple nonpharmacologic solutions such as frequent small meals, remaining upright after eating, and elevating the head of the bed will often suffice. The traditional use of agents in their order of development (antacids, H2-blockers, then proton pump inhibitors) finds some justification in this review for selected agents. Particularly enlightening was the rationale for specific agents: aluminum phosphate has efficacy as an antacid; ranitidine is the only studied H2-blocker; and there are 3 FDA category B proton pump inhibitors (pantoprazole, lansoprazole, and rabeprazole). Specific recommendations for these agents would improve patient benefit with a minimum of therapeutic trials frustrating both patient and physician.
Generic Name: pantoprazole (oral/injection) (pan TOE pra zole)
Brand Names: Protonix
Medically reviewed by Kaci Durbin, MD Last updated on Jan 15, 2019.
- Side Effects
What is Protonix?
Protonix (pantoprazole) is a proton pump inhibitor that decreases the amount of acid produced in the stomach.
Protonix is used to treat erosive esophagitis (damage to the esophagus from stomach acid caused by gastroesophageal reflux disease, or GERD) in adults and children who are at least 5 years old. Pantoprazole is usually given for up to 8 weeks at a time while your esophagus heals.
Protonix is also used to treat Zollinger-Ellison syndrome and other conditions involving excess stomach acid.
Protonix is not for the immediate relief of heartburn symptoms.
Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.
Long-term treatment with Protonix may also make it harder for your body to absorb vitamin B-12, resulting in a deficiency of this vitamin. Talk with your doctor if you need long-term Protonix treatment and you have concerns about vitamin B-12 deficiency.
Pantoprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.
Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.
Pantoprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.
You may be more likely to have a broken bone while taking this medicine long term or more than once per day.
Before taking this medicine
Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.
You should not use Protonix if:
you also take medicine that contains rilpivirine (Edurant, Complera, Juluca, Odefsey); or
you are allergic to pantoprazole or similar medicines (lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, and others).
Tell your doctor if you have ever had:
low levels of magnesium in your blood;
osteoporosis or low bone mineral density.
You may be more likely to have a broken bone while using Protonix long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy, especially if you are an adult over 50.
It is not known whether Protonix will affect an unborn baby. Animal studies have shown no harm. Tell your doctor if you are pregnant or plan to become pregnant.
Protonix is secreted in breastmilk, but it is not known whether Protonix will affect a nursing infant. Tell your doctor you are nursing before taking Protonix.
Protonix is not approved for use by anyone younger than 5 years old.
How should I use Protonix?
Take Protonix exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Use the lowest dose for the shortest amount of time needed to treat your condition.
Protonix is taken by mouth (oral) or given as an infusion into a vein (injection). A healthcare provider may teach you how to properly use the injection by yourself.
Protonix tablets are taken by mouth, with or without food. The oral granules should be taken 30 minutes before a meal.
Do not crush, chew, or break a Protonix tablet. Swallow the tablet whole.
The oral granules should be sprinkled on 1 teaspoon of applesauce or apple juice and given either by mouth or through a nasogastric (NG) tube.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.
Call your doctor if your symptoms do not improve or if they get worse while you are using this medicine.
Pantoprazole can cause false results with certain medical tests. Tell the doctor or laboratory staff that you are using this medicine.
Pantoprazole may also affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use this medicine.
Store this medicine at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Protonix?
This medicine can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Protonix side effects
Get emergency medical help if you have signs of an allergic reaction to Protonix: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
severe stomach pain, diarrhea that is watery or bloody;
sudden pain or trouble moving your hip, wrist, or back;
bruising or swelling where intravenous pantoprazole was injected;
urinating less than usual, blood in your urine, swelling, rapid weight gain;
dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling (symptoms of low magnesium); or
new or worsening symptoms of lupus – joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.
Taking pantoprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.
If you use pantoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.
Common Protonix side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Protonix?
Tell your doctor about all your other medicines. Some may interact with pantoprazole, especially:
human immunodeficiency virus (HIV medications) such as rilpivirine, atazanavir, or nelfinavir;
blood thinners including warfarin;;
a diuretic or “water pill.”
This list is not complete. Other drugs may affect Protonix, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Protonix only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2020 Cerner Multum, Inc. Version: 19.02.
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