This is because sulfasalazine can reduce levels of folic acid in the body. It is also should be monitored carefully in patients with decreased kidney function, or decreased liver function. This means that it is not expected to harm an unborn baby. It is very important to take any medicines prescribed to treat ulcerative colitis, Crohn’s disease, and rheumatoid arthritis. I have been taking sulfasalazine for rheumatoid arthritis for a little over a year now. Oral sulfasalazine inhibits absorption and metabolism of folic acid which may interfere with folic acid supplementation and reduce its periconceptional effect. Take sulfasalazine after a meal or with a light snack, then drink a full glass of water. There are, however, no adequate and well-controlled studies in pregnant women. LactMed/WHO: Use of sulfasalazine should be avoided if possible, especially if the nursing infant is premature or younger than 1 month; however, use of sulfasalazine is not a reason to discontinue breastfeeding if the drug is required by the mother. You can update your details at any time during pregnancy or afterwards. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. It is unclear exactly how it works. In 186 pregnancies in women treated with sulfasalazine alone or with concomitant steroid therapy, the incidence of fetal morbidity and mortality was comparable to 245 untreated IBD pregnancies and to pregnancies in the general population. Pregnancy and Conception with methotrexate. Select one or more newsletters to continue. There are no controlled data in human pregnancy.Sulfasalazine and its metabolite, sulfapyridine, pass through the placenta. This factsheet has been written for members of the public by the UK Teratology Information Service (UKTIS). If a new medicine is suggested for you during pregnancy, please ensure the doctor or health care professional treating you is aware of your pregnancy. Fertility, pregnancy and breastfeeding Guidelines state that it's safe for women to continue using sulfasalazine when trying for a baby and during pregnancy. Pregnancy: Teratogenic Effects : Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 6 times the human dose and have revealed no evidence of impaired female fertility or harm to the fetus due to sulfasalazine. Pregnant patients taking sulfasalazine should increase their folate supplementation to 2 mg/ … In cases where outcome was reported, the infant's bloody stools or diarrhea resolved after the mother discontinued sulfasalazine or breastfeeding was discontinued. To have your say on how we can improve our website and the information we provide please visit here. Every pregnancy is unique. The oldest and least expensive of the 5-ASA compounds, sulfasalazine is composed of sulfapyridine and 5-ASA molecules. Am J Obstet Gynecol 127 (1977): 443-4, Cerner Multum, Inc. "Australian Product Information." The oldest and least expensive of the 5-ASA compounds, sulfasalazine is composed of sulfapyridine and 5-ASA molecules. ([1999]): Royal Australian College of General Practicioners (RACGP), the Pharmaceutical Society of Australia (PSA), the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT) "Australian Medicines Handbook. It is taken by mouth. New Reply Follow New Topic. In one infant, umbilical cord serum levels of sulfasalazine and sulfapyridine were equal to maternal serum levels. By dale59166044 | 1 post, last post over a year ago. Sulfasalazine is a prescription medication used to treat the symptoms of ulcerative colitis including bowel inflammation, diarrhea (stool frequency), rectal bleeding, and abdominal pain. Sulfasalazine is in the FDA pregnancy category B. O 0, Hoo JJ, Hadro TA, Von Behren P "Possible teratogenicity of sulfasalazine." ... Pregnancy. New Reply Follow New Topic. Sulfasalazine falls into category B. A review compared 287 pregnancies in women with ulcerative colitis or Crohn's disease treated with sulfasalazine and/or steroids to 244 pregnancies in women who were not treated. It is composed of 5-aminosalicylic acid (5-ASA) joined to sulfapyridine by an azo-linkage. Do not stop sulfasalazine without speaking to your midwife, GP, or specialist. ([cited 2013 -]): Branski D, Kerem E, Gross-Kieselstein E, Hurvitz H, Litt R, Abrahamov A "Bloody diarrhea--a possible complication of sulfasalazine transferred through human breast milk." If you become pregnant while taking sulfasalazine, call your doctor. We would not expect any increased risk to your baby if the father takes sulfasalazine. They can access more detailed medical and scientific information from www.uktis.org. In one infant, umbilical cord serum levels of sulfasalazine and sulfapyridine were equal to maternal serum levels. Disclaimer: This information is not intended to replace the individual care and advice of your health care provider. I have been using Azulfidin for three weeks as a part of my treatment of ulcerative colitis, prescribed by my doctor, of course. Our online reporting system offers all pregnant women, and women who have been pregnant in the past, the opportunity to create their own digitally secure ‘my bumps record’. Up to 1 out of every 5 pregnancies ends in a miscarriage, and 1 in 40 babies are born with a birth defect. However, the majority of cases treated with sulfasalazine during pregnancy result in normal deliveries (12) without known teratogenic sequelae (13). A study of 1455 pregnancies with exposure to sulfonamides showed that these drugs did not appear to be associated with fetal malformations. Medically reviewed by Drugs.com. Sulfasalazine is a prodrug composed of 5-ASA linked to sulfapyridine through … Fertility, pregnancy, and nursing in inflammatory bowel disease View in Chinese …Medications may decrease fertility in men. They describe the chance of these events happening for any pregnancy before taking factors such as the mother’s health during pregnancy, her lifestyle, medicines she takes and the genetic make up of her and the baby’s father into account. This drug should be used during pregnancy only if clearly needed.AU TGA pregnancy category: AUS FDA pregnancy category: BComments: This drug inhibits folic acid absorption and metabolism. The decision to start, stop, continue or change a prescribed medicine before or during pregnancy should be made in consultation with your health care provider. TGA. Department of Adolescent and Child Health and Development. Bumps uses cookies to ensure that we give you the best experience on our website. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. N Engl J Med 318 (1988): 1128. Caution should be used, It is considered by some to be a first line treatment in rheumatoid arthritis. Your doctor will only prescribe medicines when absolutely necessary and will be happy to talk to you about any concerns that you might have. Provide information about your pregnancy to help women in the future. Safety of rheumatic disease medication use during pregnancy and lactation …following medications are viewed as relatively safe in pregnancy: Hydroxychloroquine (HCQ) Sulfasalazine (SSZ) Low-dose aspirin Azathioprine (AZA) and 6-mercaptopurine (6-MP) Colchicine Pregnancy … Gastroenterology 80 (1981): 72-6, Cerner Multum, Inc. "UK Summary of Product Characteristics." It is very helpful if you can record all your medication taken in pregnancy in your hand held maternity records. ... Sulfasalazine (Azulfidine®) is an effective DMARD for the treatment of RA. Sometimes this may have beneficial effects for the baby. Sulfasalazine comes as regular and delayed-release (releases the medication in the intestine to prevent irritation to the stomach and to allow the medication to work in the intestine where its effects are needed) tablets. There are, however, some medicines that can harm a baby’s normal development. Sulfonamides, including sulfasalazine, are present in human milk (see Pregnancy, Clinical Considerations). Although sulfapyridine has poor bilirubin-displacing capacity, newborns should be monitored for kernicterus.Cases of neural tube defects have been reported in infants born to mothers exposed to this drug during pregnancy; causality has not been established. Available from: URL: https://www.amh.net.au/", "Drugs for rheumatoid arthritis." Sulfasalazine should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. WE NEED YOUR HELP! It can also be used to treat other diseases such as psoriatic arthritis, Crohn's disease and ulcerative colitis. This information will help us better understand how medicines affect the health of pregnant women and their babies. Theoretical risk of neonatal haemolysis in third trimester; adequate folate supplements should be given to mother. Even women who have been given higher doses had no problems during their pregnancy and their babies didn’t have any problems. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. We comply with the HONcode standard for trustworthy health information -. It also controls unpleasant symptoms that can affect quality of life, and can help to prevent the pregnancy complications that have been associated with these illnesses. If you are on regular medication you should discuss these effects with your doctor/health care team before becoming pregnant. Tell your doctor if you are pregnant. Sulfasalazine (SSZ), a dihydrofolate reductase inhibitor, is a category B medication; it does not increase fetal morbidity or mortality and is considered safe in pregnancy. For non-prescription products, read the label or package ingredients carefully. However, safety and efficacy have not been established in children younger than 6 … Periconceptional folic acid supplementation has been shown to decrease risk of neural tube defects.A national survey evaluated outcomes of pregnancies associated with inflammatory bowel disease (IBD). Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Sulfasalazine may make your skin sensitive to sunlight. momx5101981 over a year ago. Talk to your doctor as soon as possible if you are planning a family, or if you become pregnant while taking sulfasalazine. By momx5101981. Pregnancy and Conception with methotrexate. I have heard that this medication decreases absorption of folic acid. Sulfasal- If you’re pregnant and taking sulfasalazine, you should also take folic acid tablets. These data do not support an association to birth defects. Started having stiffness and pain in joints and thought it … There are no concerns that taking sulfasalazine in pregnancy causes problems in the baby and it is routinely prescribed for pregnant women with ulcerative colitis, Crohn’s disease, and rheumatoid arthritis. Join my bumps, https://www.medicinesinpregnancy.org/Login/. What are the benefits of taking sulfasalazine in pregnancy? {ref28} Moreover, sulfasalazine passes into breast milk and the effects of sulfasalazine on a nursing infant are not known. Sulfonamides compete with bilirubin for plasma protein binding sites and may cause kernicterus in newborns. Significant side effects occur in about 25% of people. Monitoring for signs and symptoms of diarrhea and/or bloody stools in infants receiving breast milk from mothers taking sulfasalazine is recommended. There have not been any notable effects on sperm production or ovarian function after the prolonged administration of methotrexate. The incidence of abnormalities was not significantly different between the treated and untreated patients. sulfasalazine azulfidine during pregnancy A 39-year-old female asked: does the intake of folic acid needs to be increased while taking sulfasalazine during a pregnancy? Sulfasalazine is in the disease-modifying antirheumatic drugs (DMARDs) family of medications. Sulfasalazine can be used in pregnancy. Sulfasalazine delayed-release (enteric-coated) is also used to treat rheumatoid arthritis in adults and children when other medications have not worked. Sulfasalazine should not be prescribed for patients who are hypersensitive to salicylates or sulfa drugs. Taking sulfasalazine can make it harder for your body to absorb folic acid, and folic acid helps prevent major birth defects of the baby's brain or spine. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Sulfasalazine is considered safe to use while you are breastfeeding, unless the baby is premature or at risk of jaundice. Craxi A, Pagliarello F "Possible embryotoxicity of sulfasalazine." Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk. Advice in pregnancy/breastfeeding. Follow the directions on your prescription label carefully, and ask your d… The FDA categorizes medications based on safety for use during pregnancy. Please visit https://www.medicinesinpregnancy.org/Login/ to register. Sulfasalazine does not increase the risk of any complications of pregnancy or the risk of birth defects. Azulfidine (sulfasalazine)." I found out this morning that I am pregnant. Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sulfasalazine enteric-coated tablets to treat juvenile rheumatoid arthritis in children. The mother was determined to be a slow acetylator of sulfonamides. A medical literature review of 1155 pregnancies in women with ulcerative colitis suggested outcomes were similar to those expected in the general population.Use during pregnancy appears to be safe. Treat Guidel Med Lett 7 (2009): 37-46, Hensleigh PA, Kauffman RE "Maternal absorption and placental transfer of sulfasalazine." If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the Bumps website. Also in this case, the maternal sulfasalazine treatment was a suspected cause of the fetal hematological disorder. "Product Information. Breast feeding. Check with your doctor if you have/take any of the following to see if Sulfasalazine is the right medication for you: Don’t worry, it has been shown that there was no increased risk for women who have been treated with Azulfidin (Sulfasalazine) in compare to other women who have not been taken this medicine. Sulfasalazine decreases the amount of folic acid that your body absorbs. However, unlike sulfasalazine, many DMARDs may be unsuitable for women who are, or may become, pregnant because of their potential to cause teratogenic effects. Sulfasalazine (SSZ), sold under the trade name Azulfidine among others, is a medication used to treat rheumatoid arthritis, ulcerative colitis, and Crohn's disease. For many, ongoing use of sulfasalazine in pregnancy will be considered appropriate. We have a great page on this drug which includes some useful information on pregnancy for those planning a family: Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Pregnancy and Lactation. There are no controlled data in human pregnancy. Use during pregnancy appears to be safe for the baby. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Our bumps leaflets are written to provide you with a summary of what is known about use of a specific medicine in pregnancy so that you can decide together with your health care provider what is best for you and your baby. When deciding whether or not to use a medicine in pregnancy you need to weigh up how the medicine might improve your and/or your unborn baby’s health against any possible problems that the drug may cause. Sulfonamides, including sulfasalazine, are present in human milk. UKTIS has been providing scientific information to health care providers since 1983 on the effects that medicines, recreational drugs and chemicals may have on the developing baby during pregnancy. sulfasalazine should be used during pregnancy only if clearly needed. Sulfasalazine may also offer a more rapid onset of action than other DMARDs and may slow down the radiological progression of RA. Available for Android and iOS devices. Sulfasalazine (at doses up to 2g/day) with folate supplementation is safe to continue whilst trying to conceive and throughout pregnancy. Other medicines can be used to treat ulcerative colitis, Crohn’s disease, and rheumatoid arthritis. Available from: URL: http://www.tga.gov.au/docs/pdf/medpreg.pdf." Another infant whose mother was treated with sulfasalazine throughout pregnancy was born with microcephaly, ventricular septal defect, and coarctation of the aorta. Insignificant amounts of sulfasalazine have been found in milk, whereas levels of the active metabolite sulfapyridine in milk are about 30 to 60 percent of those in the maternal serum. 53 It should be avoided in women who will be pursuing pregnancy even in the upcoming years due to its long half-life. Because sulfasalazine can potentially affect folic acid levels, women taking it while trying to conceive and during pregnancy should be prescribed a high dose folic acid supplement. There is little evidence of fetal risk with sulfasalazine, as long as the expectant mother … Cautions. Sulfasalazine has been in use for more than 30 years. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Login to my bumps It also controls unpleasant symptoms that can affect quality of life, and can help to prevent the pregnancy complications that have been associated with these illnesses. If the nursing infant is glucose-6-phosphate dehydrogenase (G6PD) deficient, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.-AU: Sulfasalazine should not be used unless the benefit to the mother outweighs the risk to the infant; caution is recommended, especially if the nursing infant is premature or G6PD deficient.-UK: Breastfeeding is not recommended during use of sulfasalazine.-US: Caution is recommended.Excreted into human milk: YesComments:-Use of drugs that do not contain a sulfonamide is preferred.-Nursing infants should be monitored closely for side effects (e.g., bloody diarrhea, jaundice, hemolysis). Insignificant amounts of sulfasalazine and 5-ASA (but rather high levels of N-acetyl-5-ASA [the 5-ASA metabolite]) are found in breast milk; some experts consider 5-ASA derivatives safe during breastfeeding. Left untreated these can be serious and can also lead to pregnancy complications. It's often recommended that you continue sulfasalazine throughout pregnancy to prevent flare-ups. Sulfapyridine has levels in milk about 30% to 60% of those in maternal serum. Sulfasalazine is considered a pregnancy category B drug. Sulfasalazine is an orally applicable, well-known drug, mainly used in rheumatology, with an anti-inflammatory and immunomodulatory efficacy. Do you have 3 minutes to complete a short, quick and simple 12 question user feedback form about our bumps information leaflets? The reaction was probably caused by sulfasalazine or one of its metabolites in breast milk; diarrhea has been reported in breastfed infants with both sulfapyridine and 5-ASA.Cases (with limited data) of bloody stools or diarrhea have been reported in infants fed breast milk from mothers taking sulfasalazine. No extra monitoring for major birth defects is required following sulfasalazine use in pregnancy. Sulfasalazine has been in use for more than 30 years. According to the authors, the reaction was likely due to an allergic reaction to sulfapyridine. Sulfasalazine (SSZ), a dihydrofolate reductase inhibitor, is a category B medication; it does not increase fetal morbidity or mortality and is considered safe in pregnancy. Sulfonamides compete with bilirubin for plasma protein binding sites and may cause kernicterus in newborns. One proposed mechanism is the inhibition of prostaglandins, resulting in local anti-inflammatory effects in the colon. The incidence of spontaneous abortion, premature birth, and low birth weight in the treated infants was less than the predicted values based on the general population.In a review of 229,101 deliveries to Michigan Medicaid patients, 72 first-trimester exposures and 72 exposures any time during pregnancy were recorded. United States National Library of Medicine "Toxnet. However, where a woman’s illness is well-controlled with sulfasalazine, staying on it may be the best option. A total of 2 birth defects were reported with first trimester exposure and 1 with exposure during pregnancy. Sulfonamides compete with bilirubin for plasma protein binding sites and may cause kernicterus in newborns. Pregnancy category: B; D if used for prolonged periods or near term; increased potential for kernicterus in the newborn. We strongly advise that printouts should NOT be kept for any length of time, or for “future reference” as they can rapidly become out of date. There have not been any notable effects on sperm production or ovarian function after the prolonged administration of methotrexate. become pregnant. (written communication, Franz Rosa, MD, US FDA, 1994)Agranulocytosis has been reported in a newborn whose mother took sulfasalazine and prednisone throughout pregnancy. Although sulfapyridine has poor bilirubin-displacing capacity, newborns should be monitored for kernicterus.One breastfed infant developed bloody diarrhea while the mother ingested sulfasalazine. Sulfasalazine is a medicine that dampens the immune response. If you have an unplanned pregnancy while taking it, you should be reviewed at the earliest opportunity by your specialist. Sulfasalazine is also known as: Azulfidine, Azulfidine EN-tabs, Sulfazine. The diarrhea resolved 48 to 72 hours after the mother discontinued sulfasalazine. Available from: URL: http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1" ([2003]). UKTIS is a not-for-profit organisation funded by Public Health England on behalf of UK Health Departments. Sulfasalazine is also compatible with breast-feeding in a healthy, full-term infant. The effects of N-acetyl-5-ASA on the nursing infant are not known. Most medicines used by the mother will cross the placenta and reach the baby. sulfasalazine and prednisone therapy due to mater-nal Crohn’s disease. However, if you would like to, you can change your cookie settings at any time. Therapeutic Goods Administration. Sulfasalazine is one of the widely used drugs in the treatment of patients with inflammatory bowel disease. Cleft palate and severe hydrocephalus has also been reported in an infant.AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.