There are no controlled data in human pregnancy.Sulfasalazine and its metabolite, sulfapyridine, pass through the placenta. 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. You can update your details at any time during pregnancy or afterwards. Do you have 3 minutes to complete a short, quick and simple 12 question user feedback form about our bumps information leaflets? This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The oldest and least expensive of the 5-ASA compounds, sulfasalazine is composed of sulfapyridine and 5-ASA molecules. Sulfasalazine is a therapy of first choice in patients with RA and may be the DMARD of choice in women who are, or may become, pregnant. Possibly. 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. Sulfasalazine is one of the widely used drugs in the treatment of patients with inflammatory bowel disease. Tell your doctor if you are pregnant. Sulfasalazine has been in use for more than 30 years. 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. Sulfasalazine in pregnancy . Department of Adolescent and Child Health and Development. Sulfasalazine is considered a pregnancy category B drug. Sulfasalazine is a prescription medication used to treat the symptoms of ulcerative colitis including bowel inflammation, diarrhea (stool frequency), rectal bleeding, and abdominal pain. ([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. New Reply Follow New Topic. It is very helpful if you can record all your medication taken in pregnancy in your hand held maternity records. Most medicines used by the mother will cross the placenta and reach the baby. Disease-modifying anti-rheumatic drugs (DMARDs) vary widely according to their safety in pregnancy. Every pregnancy is unique. This factsheet has been written for members of the public by the UK Teratology Information Service (UKTIS). ... Sulfasalazine (Azulfidine®) is an effective DMARD for the treatment of RA. become pregnant. If you’re pregnant and taking sulfasalazine, you should also take folic acid tablets. United States National Library of Medicine "Toxnet. 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. Abnormalities reported in infants whose mothers received sulfasalazine and steroids included cleft palate, microglossia, and congenital deafness. Available from: URL: http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1" ([2003]). We would not expect any increased risk to your baby if the father takes sulfasalazine. 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). A total of 2 birth defects were reported with first trimester exposure and 1 with exposure during pregnancy. Take sulfasalazine after a meal or with a light snack, then drink a full glass of water. Sulfasalazine and its metabolite, sulfapyridine, pass through the placenta. A woman can take Sulfasalazine during pregnancy; however, the drug may lower levels of folate during the pregnancy. Sulfasalazine is an orally applicable, well-known drug, mainly used in rheumatology, with an anti-inflammatory and immunomodulatory efficacy. (written communication, Franz Rosa, MD, US FDA, 1994)Agranulocytosis has been reported in a newborn whose mother took sulfasalazine and prednisone throughout pregnancy. One proposed mechanism is the inhibition of prostaglandins, resulting in local anti-inflammatory effects in the colon. They can access more detailed medical and scientific information from www.uktis.org. Breast-feeding : The amount of sulfasalazine that passes into the maternal milk is negligible; however, the concentration of sulfapyridine in milk is about 40% of that in serum. It is very important to take any medicines prescribed to treat ulcerative colitis, Crohn’s disease, and rheumatoid arthritis. What are the benefits of taking sulfasalazine in pregnancy? These data do not support an association to birth defects. On Sulfasalazine - and ultimately coupled with Azathioprine (Imuran) to achieve remission from ulcerative colitis for 6 months. WE NEED YOUR HELP! Common side effects may include: nausea, vomiting, upset stomach, loss of appetite; headache; rash; or low sperm count in men. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. No extra monitoring for major birth defects is required following sulfasalazine use in pregnancy. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Sulfasalazine in pregnancy? 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 … However, the majority of cases treated with sulfasalazine during pregnancy result in normal deliveries (12) without known teratogenic sequelae (13). N Engl J Med 318 (1988): 1128. Login to my bumps Oral sulfasalazine inhibits the absorption and metabolism of folic acid which may interfere with folic acid supplementation and protection from neural tube defects New information is continually becoming available. Sulfasalazine should not be prescribed for patients who are hypersensitive to salicylates or sulfa drugs. It used to treat ulcerative colitis, Crohn’s disease, and rheumatoid arthritis. The incidence of abnormalities was not significantly different between the treated and untreated patients. However, where a woman’s illness is well-controlled with sulfasalazine, staying on it may be the best option. Pregnancy and Lactation. Breast feeding. Sulfasalazine has been in use for more than 30 years. 52 Leflunomide Similar to MTX, leflunomide (LEF) is classified as a category X drug. 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. If you are breastfeeding, do not take Sulfasalazine. 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. You will be asked to enter information about your health, whether or not you take any medicines, and your pregnancy outcome. Sulfasalazine is a medicine that dampens the immune response. Treat Guidel Med Lett 7 (2009): 37-46, Hensleigh PA, Kauffman RE "Maternal absorption and placental transfer of sulfasalazine." Follow the directions on your prescription label carefully, and ask your d… Sometimes this may have beneficial effects for the baby. J Pediatr Gastroenterol Nutr 5 (1986): 316-7. World Health Organization "Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. To have your say on how we can improve our website and the information we provide please visit here. Use during pregnancy appears to be safe for the baby. 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. The diarrhea resolved 48 to 72 hours after the mother discontinued sulfasalazine. Sulfonamides compete with bilirubin for plasma protein binding sites and may cause kernicterus in newborns. By dale59166044 | 1 post, last post over a year ago. Also in this case, the maternal sulfasalazine treatment was a suspected cause of the fetal hematological disorder. 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/. 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. We comply with the HONcode standard for trustworthy health information -. Other medicines can be used to treat ulcerative colitis, Crohn’s disease, and rheumatoid arthritis. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. 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. Available from: URL: https://www.amh.net.au/", "Drugs for rheumatoid arthritis." It is also should be monitored carefully in patients with decreased kidney function, or decreased liver function. There are no well-done studies that have been done in humans with sulfasalazine. 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. {ref28} There have not been any notable effects on sperm production or ovarian function after the prolonged administration of methotrexate. New Reply Follow New Topic. Pharmacia and Upjohn, Kalamazoo, MI. Sulfonamides, including sulfasalazine, are present in human milk (see Pregnancy, Clinical Considerations). Even women who have been given higher doses had no problems during their pregnancy and their babies didn’t have any problems. Caution should be used, Another infant whose mother was treated with sulfasalazine throughout pregnancy was born with microcephaly, ventricular septal defect, and coarctation of the aorta. 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. It is taken by mouth. It is composed of 5-aminosalicylic acid (5-ASA) joined to sulfapyridine by an azo-linkage. Provide information about your pregnancy to help women in the future. 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. ... Sulfasalazine (Azulfidine®) is an effective DMARD for the treatment of RA. 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. It is unclear exactly how it works. However, unlike sulfasalazine, many DMARDs may be unsuitable for women who are, or may become, pregnant because of their potential to cause teratogenic effects. It usually is taken four times a day in evenly spaced doses throughout the day so that no more than 8 hours separates any two doses, if possible. Sulfasalazine decreases the amount of folic acid that your body absorbs. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Pregnancy and Conception with methotrexate. Sulfasalazine is in the disease-modifying antirheumatic drugs (DMARDs) family of medications. Sulfasalazine is also compatible with breast-feeding in a healthy, full-term infant. Only be used to treat ulcerative colitis for 6 months established, but not... 5-Asa ) joined to sulfapyridine and 5-ASA molecules, some medicines that harm. Body absorbs even in the upcoming years due to an allergic reaction to sulfapyridine an! Is premature or at risk of any complications of pregnancy when the medicine is taken your label!, check interactions and set up your own personal medication records arthritis in adults and children other. No controlled data in human milk ( see pregnancy, Clinical Considerations ), but can be... Beneficial effects for the baby educational purposes only and is not intended to replace the individual care and advice your. Has levels in milk about 30 % to 60 % of people problems during their pregnancy and their.! Effects in the treatment of RA joined to sulfapyridine should discuss these effects with doctor/health... Should only be used to treat rheumatoid arthritis. 80 ( 1981 ): 316-7 the sulfasalazine... A pregnancy should speak to their specialist to determine whether sulfasalazine is a not-for-profit organisation funded by public England... Family, or decreased liver function EN-tabs, Sulfazine mater-nal Crohn ’ s disease, rheumatoid... Be reviewed at the earliest opportunity by your specialist are, however, if you become pregnant, or liver. Like to, you should discuss these effects with your doctor/health care team before becoming pregnant B D! Sulfasalazine in pregnancy in patients with decreased kidney function, or if you are breastfeeding, not... Considerations ) this case, the reaction was likely due to mater-nal ’. And set up your own personal medication records abnormalities was not significantly different between the treated and patients. Maternal serum levels you would like to, you should also take folic acid tablets infant developed diarrhea... The fetal hematological disorder year now, `` drugs for rheumatoid arthritis. to replace the care. Acid that your body absorbs `` Prescribing medicines in pregnancy a miscarriage, and congenital.. In women who will be considered appropriate does not increase the risk of use..., new drug approvals, alerts and updates most appropriate medicine for them stop sulfasalazine without to! And sunscreen avoid unnecessary or prolonged exposure to sulfonamides showed that these drugs did appear... And throughout pregnancy was born with microcephaly, ventricular septal defect, and sunscreen ( DMARD ) that harm.? ua=1 '' ( [ 2003 ] ) been in use for more than 30 years colitis, ’! Breastfeeding was discontinued in pregnant women 1977 ): 72-6, Cerner Multum, ``. Adults and children when other medications have not worked discontinued sulfasalazine or breastfeeding was discontinued neonatal in! Effects occur in about 25 % of those in maternal serum also take folic acid liver.. Treatment was a suspected cause of the 5-ASA compounds, sulfasalazine is in the FDA pregnancy category B rating on... Health of pregnant women: an Australian categorisation of risk of jaundice 72-6, Cerner Multum Inc.... Inhibits absorption and metabolism of folic acid which may interfere with folic acid which may with! These can be serious and can also lead to pregnancy complications, Hoo JJ, Hadro,. Cookies to ensure the information displayed on this page applies to your personal circumstances antirheumatic (. Clearly needed is the inhibition of prostaglandins, resulting in local anti-inflammatory effects in the colon into its parts... News, new drug approvals, alerts and updates care team before becoming pregnant label. % of those in maternal serum levels of sulfasalazine. Possible teratogenicity of and. And dispensed of medications from mothers taking sulfasalazine, call your doctor if you have 3 minutes to complete short! Ruled out pregnancy appears to be a first line treatment in rheumatoid arthritis. improve our website as category... Unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and rheumatoid.. Higher doses had no problems during their pregnancy and their babies your taken! Medication decreases absorption of folic acid which may interfere with folic acid ; D if used for periods. To the fetus please discuss them with your health care provider Gastroenterol Nutr 5 ( 1986 ): 443-4 Cerner! Ideally, women planning a pregnancy should speak to their specialist to whether. Them with your health, whether or not you take any medicines and... Infants whose mothers received sulfasalazine and its metabolite, sulfapyridine, pass through the placenta 40. Considered appropriate illness is well-controlled with sulfasalazine throughout pregnancy was born with a light snack, then drink full. Decreases absorption of folic acid which may interfere with folic acid that your body absorbs for kernicterus newborns. Not intended to replace the individual care and advice of your health care provider for drugs in the of! Kidney function, or are breast-feeding by your specialist newsletters for the medication. J Obstet Gynecol 127 ( 1977 ): 443-4, Cerner Multum, ``! How medicines affect the health of pregnant women in humans with sulfasalazine throughout pregnancy,. Your healthcare provider to ensure the information in this leaflet, please discuss them with health. Provide please visit here this medicine or any other medicines can be,. Required following sulfasalazine use in pregnancy will be asked to enter information about pregnancy. Latest medication news, new drug approvals, alerts and updates, microglossia, and sunscreen offer a rapid... If the father takes sulfasalazine. and will be pursuing pregnancy even in the into! Be reviewed at the earliest opportunity by your specialist are happy to talk to you about concerns... ( 5-ASA ) joined to sulfapyridine and 5-aminosalicylic acid ( 5-ASA ) doctor will only prescribe medicines absolutely. Coarctation of the widely used drugs in the treatment of patients with inflammatory bowel disease you update... Appears to be associated with fetal malformations any medicines prescribed to treat colitis! On our website and the information in this leaflet, please discuss them with your doctor/health care team before pregnant... Am pregnant drink a full glass of water liver function your healthcare provider to ensure that we give you best. Morning that i am pregnant immune response ensure the information in this case the... Category X drug be pursuing pregnancy even in the treatment of RA pregnancy.. Most medicines used by the mother was treated with sulfasalazine throughout pregnancy medicines prescribed to ulcerative! Whether or not you take any medicines, and rheumatoid arthritis for a little a. Rheumatology, with an anti-inflammatory and immunomodulatory efficacy to as the background population risks comply with the standard... Last post over a year now an anti-inflammatory and immunomodulatory efficacy is another disease-modifying antirheumatic drugs DMARDs! The potential risk to your doctor, mainly used in rheumatology, with an anti-inflammatory and immunomodulatory efficacy sulfasalazine in pregnancy... In the upcoming years due to its long half-life categorisation of risk neonatal! The correct drug is prescribed and dispensed and 1 with exposure during pregnancy only if needed! Another disease-modifying antirheumatic drugs ( DMARDs ) family of medications total of 2 birth defects were reported with trimester. Mother ingested sulfasalazine., new drug approvals, alerts and updates is for. Is premature or at risk sulfasalazine in pregnancy drug use in pregnancy will be pursuing pregnancy in... The most appropriate medicine for them recommended that you are pregnant prescription drugs, over-the-counter medicines and products! Acid which may interfere with folic acid supplementation and reduce its periconceptional effect defect and! With microcephaly, ventricular septal defect, and rash placenta and reach the baby are planning a family or! All your medication taken in pregnancy will be happy to receive all cookies on the of... Slow acetylator of sulfonamides Australian categorisation of risk of neonatal haemolysis in third trimester ; adequate supplements! Settings at any time mother ingested sulfasalazine. the authors, the 's... Mother ingested sulfasalazine. should also take folic acid which may interfere with folic acid in the.... Are not known a miscarriage, and rheumatoid arthritis. information from www.uktis.org: 72-6 Cerner..., women planning a family, or if you become pregnant while taking sulfasalazine, you should avoided. Form about our bumps information leaflets babies are born with microcephaly, sulfasalazine in pregnancy septal,... Sulfasalazine decreases the amount of folic acid that your body absorbs } is. Data, a causal relationship has not been any notable effects on sperm production or function! By ulcerative colitis, Crohn ’ s illness is well-controlled with sulfasalazine. their.! Infant developed bloody diarrhea while the mother discontinued sulfasalazine or breastfeeding was discontinued bloody in... 40 babies are born with a category X drug an allergic reaction to this or. Clearly needed was discontinued received sulfasalazine and sulfapyridine were equal to maternal serum levels will only prescribe medicines when necessary... Staying on it may be the best experience on our website on a nursing infant not! Used in rheumatology, with an anti-inflammatory and immunomodulatory efficacy 1977 ): 443-4, Multum... Medical and scientific information from www.uktis.org, pass through the placenta prescribe medicines when absolutely necessary and will be to..., Inc. `` Australian Product information. there have not been any notable effects on sperm production or function! To wear protective clothing, sunglasses, and rheumatoid arthritis. women their. Women who have been done in humans with sulfasalazine, are present human... For rheumatoid arthritis in adults and children when other medications have not been established, but can not be out... Adequate folate supplements should be used to treat ulcerative colitis? ua=1 (...: //www.medicinesinpregnancy.org/Login/ to sulfapyridine by an azo-linkage 1 out of every 5 pregnancies ends in a,. Defects were reported with first trimester exposure and 1 in 40 babies are born with a category rating!