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THE SAFTEY OF APRISO 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:

Apriso (mesalamine) should only be used during pregnancy if medically necessary, as determined by your doctor. Mesalamine crosses the placenta and could harm your baby. A higher risk of birth defects has been associated with mesalamine in one study. Mesalamine has also been associated with an increased risk of premature birth, stillbirth, and having a baby with a lower birth weight. Two cases of severe anemia and kidney problems in the developing baby were also attributed to the use of mesalamine in pregnancy.

What is Apriso?

Apriso is a medication that is taken to reduce inflammation in the intestines for people who have some types of digestive disorders. The active ingredient in Apriso is mesalamine. Apriso oral capsules are delayed and extended release. Delayed release prevents the medication from getting broken down before it reaches the intestines. If the medication breaks down before reaching the intestines, it will not be as effective at relieving symptoms. Extended release enables the medication to last longer in the body so it only needs to be taken once per day, rather than multiple times per day, to have a continuous effect. Apriso is only available by prescription from your doctor.

What is Apriso used to treat?

Apriso is used to treat ulcerative colitis in adults. It is a maintenance medication used when a person with ulcerative colitis is considered to be in remission (when symptoms have disappeared). It is not used to treat flare-ups.

Ulcerative colitis is a type of inflammatory bowel disease (IBD), which is a chronic (long-lasting) inflammatory disease of the digestive tract. It is characterized by inflammation (swelling, redness, irritation, and pain) in the large intestine. The large intestine is the lower part of your digestive tract and includes the appendix, cecum, colon, and rectum. Ulcerative colitis also causes ulcers, or sores, inside the large intestine. People with ulcerative colitis often experience abdominal pain and diarrhea with blood or pus. You can read about IBD during pregnancy here.

How does Apriso work?

Apriso is effective locally (in your intestines) and reduces the production of some molecules that promote inflammation. This helps reduce the inflammation and symptoms associated with ulcerative colitis.

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

Apriso should only be used during pregnancy if medically necessary, as determined by your doctor. Mesalamine crosses the placenta and can expose your baby to its effects. Animal studies have not associated mesalamine with a higher risk of harm to the offspring. Studies have found a higher risk of birth defects with an ingredient used in some mesalamine formulations, called dibutyl phthalate (DBP). Fortunately, Apriso does not contain DBP. No adequate and well-controlled human studies have looked at the effects of mesalamine on the developing baby. However, small studies have associated mesalamine with an increased risk of premature birth, stillbirth, and having a baby with a lower birth weight. One small study also observed a higher risk of birth defects with the use of mesalamine in pregnancy.

Expecting moms with IBD have been found to have a higher rate of pregnancy complications compared to healthy expecting moms. One study reported that expecting moms with IBD had a 2.37 times higher risk of birth defects, 2 times higher risk of having a low birth weight baby, and 1.87 times higher risk of preterm delivery. Without treatment, expecting moms who have active ulcerative colitis at conception have a higher risk of worsening disease. Expecting moms with IBD also have a higher rate of relapse without treatment. Your doctor will evaluate the risks of Apriso to your baby and determine if the benefits of treatment with Apriso outweigh the risks.

Evidence:

A case has reported of an expecting mom who took mesalamine, which caused severe anemia in the baby. Anemia is a blood disorder characterized by a low number of red blood cells. Red blood cells transport oxygen to the baby’s cells and organs. Severe anemia can cause the baby’s heart to pump harder, and eventually the baby’s heart will fail, leading to hydrops fetalis. Hydrops fetalis is a life-threatening condition, where excessive amounts of fluid accumulate in the baby’s organs. In the case of the expecting mom who was taking mesalamine, the baby developed severe hydrops fetalis at about 31 weeks. The expecting mom was given red blood cell transfusions to treat the baby’s anemia, and a healthy baby was delivered after 37 weeks.

One case report described an expecting mom who took mesalamine during the third and fifth months of pregnancy. The baby developed kidney problems, which was suspected to be related to mesalamine.

A study looked at 165 expecting moms who took mesalamine. No increase in the number of birth defects was seen, but the study found an increase in the number of premature births. Moms who took mesalamine tended to gain less weight during pregnancy and tended to deliver lower birth weight babies.

Another study looked at 60 expecting moms who took a 5-aminosalicylic acid drug (5-ASA) (either mesalamine or another medication). This study found an increased risk of premature delivery and stillbirth (death of the baby after 28 weeks of pregnancy) in expecting moms with ulcerative colitis who took a 5-ASA medication. However, there was no increased risk of birth defects.

A study looked at 123 expecting moms who used mesalamine. Some of the women in this group had miscarriages, premature deliveries, and babies with birth defects. One baby also died due to a kidney disorder. The health problems and complications that were observed were not considered to be related to the use of mesalamine.

A study looked at 3651 expecting moms who took a 5-ASA drug, 2018 of whom had taken mesalamine. The study found a higher risk of birth defects, especially birth defects in the heart, with the use of all 5-ASA drugs during pregnancy. Many of the expecting moms were taking other medications simultaneously. Since active IBD increases the risk of pregnancy complications, it is unclear if the higher risk of birth defects observed with the use of mesalamine was related to the drug, a combination of medications, or the disease itself.

Bottom line: Apriso should only be used during pregnancy if medically necessary, as determined by your doctor. This medication crosses the placenta and could harm your baby. Some studies have reported that mesalamine increases the risk of premature birth, stillbirth, or delivering a low birth weight baby. A higher rate of birth defects was observed in one study in expecting moms who took 5-ASA drugs, including mesalamine. The use of mesalamine in pregnancy has also been associated with severe anemia and kidney problems in 2 case reports.

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

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

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

Caution should be used if Apriso is taken by breastfeeding moms. This medication passes into breast milk in small amounts and a component of mesalamine passes into breast milk in high amounts. The effects of exposure to Apriso in the breastfed baby are unknown. Some case reports have described breastfed babies developing diarrhea after being exposed to mesalamine from breast milk. The American Academy of Pediatrics classified mesalamine (5-aminosalicylic acid) as a drug that has been associated with significant effects in some nursing babies and should be given to nursing moms with caution. This classification is based on 1 report of diarrhea in a breastfeeding baby. If your doctor determines that mesalamine is medically necessary, you should contact your doctor immediately if your baby develops diarrhea.

Evidence:

A report described a breastfeeding mom who was given mesalamine suppositories. The 6-wee
k old breastfed baby developed watery diarrhea 12 hours later. The mesalamine was stopped and restarted 4 times. Each time the mesalamine was restarted, the baby developed diarrhea 8 to 12 hours later, which stopped 8 to 12 hours after the mesalamine dose was given. The diarrhea was considered probably related to mesalamine.

A report describes a breastfeeding mom who was taking mesalamine orally throughout pregnancy and while breastfeeding. She stopped breastfeeding, and 1 week later, her 4-month old breastfed baby developed a blood clot in the sinuses. The authors concluded that the blood clot was caused by mesalamine. Since the baby had been continually exposed to the drug, and it was then suddenly discontinued, the blood clot was thought to be due to the change in exposure to mesalamine.

One small study followed 8 breastfeeding moms who were taking mesalamine. One of the moms reported that her baby developed diarrhea.

Another small study found no increased rate of diarrhea among breastfed babies whose moms were taking mesalamine.

Bottom line: Caution should be used if Apriso is taken by breastfeeding moms. Apriso passes into human breast milk, and mesalamine has been associated with causing diarrhea in breastfed babies. Exposure to mesalamine was also considered to be related to a blood clot that developed in a breastfed baby.

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

The effects of Apriso on fertility have not been studied. Fertility is similar in women with IBD compared to women in the general population, while men with IBD have lower fertility rates. Additionally, fertility in men or women with IBD can be affected both by medications and active inflammation. 

If I am taking Apriso, what should I know?

Apriso should only be used during pregnancy if medically necessary, as determined by your doctor. This medication crosses the placenta and may cause harm to your baby. Two case reports have associated the use of mesalamine in pregnancy with causing severe anemia and kidney problems in the developing baby. A higher risk of birth defects was observed with the use of mesalamine in one study. Some studies have also reported a higher risk of premature birth, stillbirth, or low birth weight.

Caution should be used if Apriso is taken by breastfeeding moms. This medication passes into breast milk, and mesalamine has been associated with causing diarrhea in breastfed babies. Mesalamine has also been associated with causing a blood clot in a breastfed baby.

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

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

You may find Pregistry's expert reports about ulcerative colitis here,  reports about the individual medications used to treat digestive system disorders here, and a report about IBD here. Additional information can also be found in the resources below. 

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

Crohn’s & Colitis: Understanding Ulcerative Colitis

Apriso RX: Apriso Dosing

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.