Pariet

THE SAFETY OF ACIPHEX DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:

Aciphex, a type of proton pump inhibitor (PPI), should only be used during pregnancy if medically necessary and the benefits to the mom outweigh the potential risks to the baby. Taking a PPI during pregnancy can increase the risk that your baby will develop childhood asthma. Evidence from research on the use of other PPIs in pregnancy shows that taking these medications in the months before conception may increase the risk of birth defects.

What is Aciphex?

Aciphex is a medication that is taken to reduce stomach acid. Certain diseases cause stomach acid to move in the wrong direction up into your esophagus (the tube that transports food from your mouth to your stomach). This can cause symptoms of coughing, sore throat, bitter taste, bad breath, and heartburn, a burning sensation in your throat or chest that usually occurs after eating. You can read more about heartburn during pregnancy here. Aciphex contains the active ingredient rabeprazole, which is a type of proton pump inhibitor (PPI). This medication is only available by prescription from your doctor.

What is Aciphex used to treat?

Aciphex is used to treat gastroesophageal reflux disease (GERD). It can also be used as part of a treatment plan for ulcers or to heal damage to the esophagus that occurs from long-term exposure to stomach acid.

What is GERD?

In GERD, the muscle separating your esophagus from your stomach does not work properly. This allows stomach acid to flow into your esophagus (acid reflux). If you have acid reflux, you may experience heartburn or have a sour taste in the back of your throat. People with GERD have acid reflux that occurs at least twice per week and lasts for several weeks. GERD can produce more serious symptoms, such as difficulty swallowing, coughing, vomiting, pain in the upper chest, and lung problems. The esophagus can also become injured because it is continuously being exposed to stomach acid. During pregnancy, changes in your body’s hormones can increase the likelihood that you will develop GERD. You can read more about GERD during pregnancy here.

How does Aciphex work?

Aciphex reduces the amount of acid that your stomach releases. This reduces the amount of stomach acid that your esophagus is exposed to if acid reflux occurs. Aciphex provides relief from symptoms of acid reflux and allows damaged tissue in the esophagus to heal. It is most effective when taken 30 minutes before your first meal of the day.

If I am taking Aciphex, can it harm my baby?

Aciphex should only be used during pregnancy if medically necessary and the benefits to the mom outweigh the potential risks to the baby. There is no human data available on the safety of rabeprazole during pregnancy. Studies that have looked at other PPIs in pregnancy have found that taking these medications prior to conception may increase the risk of birth defects. Additionally, studies have found that taking PPIs during pregnancy may increase the risk that your baby will develop childhood asthma.

Evidence:

A large study looked at 5,082 expecting moms who had taken a PPI between 4 weeks prior to conception and the end of the first trimester. The study found that expecting moms who took a PPI within 4 weeks before conception had a significantly higher risk of having a baby with a major birth defect, specifically heart and urinary defects. No increased risk of major birth defects was found for expecting moms who took a PPI during the first trimester. The study included 34 reports for babies whose moms took rabeprazole within 4 weeks prior to conception (including 2 babies with birth defects) and 45 reports for babies exposed to rabeprazole during the first trimester (including 3 babies with birth defects). No conclusions could be made regarding the safety of rabeprazole in pregnancy because too few expecting moms took this medication during the study.

Although no other studies have looked at the safety of rabeprazole during pregnancy, several studies have looked at the safety of other types of PPIs during pregnancy. A study that analyzed 955 pregnancy outcomes from the Swedish Medical Birth Registry found that women who took omeprazole (another type of PPI) during pregnancy had a slightly higher percentage of stillborn babies and babies born with heart defects. However, the authors concluded that this small increase could have been by chance, and that overall, omeprazole taken during pregnancy was not associated with an increased risk of negative pregnancy outcomes.

One small study found a higher risk of specific birth defects with the use of PPIs during pregnancy. Other studies have found that taking a PPI during pregnancy was not associated with an increased risk of birth defects, including: 1530 expecting moms who used a PPI during pregnancy; 593 expecting moms who used a PPI during the first trimester of pregnancy; 410 expecting moms who took a PPI during pregnancy; 113 expecting moms who used omeprazole during the first trimester of pregnancy; and 1186 expecting moms who used a PPI during the first trimester of pregnancy.

Separate from the risk of birth defects, expecting moms who take PPIs during pregnancy may increase the chances that their baby will develop childhood asthma. Two studies looked at over 2000 children whose moms used a PPI during pregnancy. Both studies found that taking a PPI during pregnancy increased the chance that the baby would develop childhood asthma. The increased risk of asthma is thought to be due to the stomach acid reducing properties of PPIs. Therefore, this effect would likely be associated with the use of Aciphex.

Bottom line: Rabeprazole should only be used during pregnancy if medically necessary and the benefits to the mom outweigh the potential risks to the baby. Taking PPIs during pregnancy can increase the risk that your baby will develop childhood asthma. Evidence from studies on the use of other PPIs in pregnancy has found that taking these medications prior to conception may increase the risk of birth defects.

If I am taking Aciphex and become pregnant, what should I do?

If you become pregnant while taking Aciphex, you should contact your doctor immediately. Your doctor will decide if your medication is medically necessary, or if it should be discontinued until after the birth of your baby.

If I am taking Aciphex, can I safely breastfeed my baby?

Caution should be used if Aciphex is taken while breastfeeding. Your doctor will determine whether Aciphex is medically necessary and if breastfeeding should be continued. It is unknown if this medication passes into human breast milk. In animal studies, Aciphex has been shown to pass into rat milk. There have been no case reports of breastfed babies whose moms were taking Aciphex. This medication has the potential to cause serious side effects in your baby. Animal studies have shown that Aciphex may be a potential carcinogen at high doses. Additionally, this medication could interfere with your baby’s digestion by reducing the amount of stomach acid your baby produces. Therefore, some experts recommend avoiding the use of Aciphex while breastfeeding. 

Bottom line: Caution should be used if Aciphex is taken while breastfeeding. There is no data available on the safety of Aciphex in the breastfed baby. Some experts recommend avoiding the use of Aciphex while breastfeeding because it likely passes into breast milk and can cause health problems in your baby.   

If I am taking Aciphex, will it be more difficult to get pregnant?

No studies have looked at the effects of PPIs on a woman’s fertility; however, some evidence has shown that PPIs may interfere with a man’s ability to father a child. A study showed that men who had used a PPI 6 to 12 months before a semen analysis had a 3 times higher risk of having low sperm counts, which may interfere with fertility. 

If I am taking Aciphex, what should I know?

Aciphex should only be used duri
ng pregnancy if medically necessary and the potential benefits to the mom outweigh the potential risks to the baby. There is no human data available on the safety of this medication in pregnancy. Evidence on the safety of other PPIs in pregnancy has found that taking a PPI prior to conception may increase the risk of birth defects. Additionally, taking a PPI during pregnancy may increase the risk that your baby will develop childhood asthma.

Caution should be used if taking Aciphex while breastfeeding. There is no data on the safety of this medication in breastfed babies. Many experts recommend avoiding this medication while breastfeeding because it likely passes into breast milk and can cause health problems in your baby.  

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of Aciphex during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert report about proton pump inhibitors here, GERD here, and reports about the various medications used for digestive system disorders here.   Additional information can also be found in the resources below. 

For more information about Aciphex and GERD during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

U.S. Food and Drug Administration: Aciphex Prescribing Information

Mayo Clinic: Gastroesophageal reflux disease (GERD)

U.S. Department of Health and Human Services: Symptoms & Causes of GER & GERD

Read the whole report
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.