Suspected Spontaneous Reports of Birth Defects in the UK Associated with the Use of Carbimazole and Propylthiouracil in Pregnancy. Advice for healthcare professionals. Because this drug crosses the placenta and can induce goiter and cretinism in the developing fetus, excessive doses should not be given during pregnancy. pregnancy, upcoming surgery, etc. Carbimazole is an antithyroid medicine, which is used for treating hyperthyroidism. If you have taken carbimazole or methimazole after week 10 of pregnancy, and/or if you have Graves’ disease, your baby’s thyroid function should be monitored after delivery. Re-exposure to carbimazole may result in life-threatening acute pancreatitis. New information is continually becoming available. I worried that this would have caused harm to my baby as I shouldn’t have conceived whilst taking carbimazole. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version. Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. Methimazole Uses: ... Pregnancy Risk Factor D. Methimazole can cross the placenta. Sometimes this may have beneficial effects for the baby. Remember only a suspicion is needed to report – if in doubt, please complete a Yellow Card. Eleven mothers were taking oral carbimazole in dosages ranging from 5 to 20 mg daily during pregnancy and 5 to 15 mg daily during breastfeeding (extent not stated). Worldwide, the thionamides-propylthiouracil, methimazole, and carbimazole-have been used in pregnancy for the treatment of hyperthyroidism. If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Yoshihara A, Noh J, Yamaguchi T, et al. It is mainly during this time that some medicines are known to cause birth defects. If carbimazole is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended. There is concern over whether carbimazole/methimazole or propylthiouracil is the most appropriate antithyroid drug to use when treating hyperthyroidism in pregnant women. Click Here to Manage Email Alerts Back to Healio If present, then referral to a fetal medicine unit is indicated. ), allergies, pre-existing diseases, and current health conditions (e.g. Close maternal, foetal and neonatal monitoring is warranted (see Section 4.6 Fertility, pregnancy and lactation, Use in pregnancy). Package leaflet . Endocrine disorders are a significant reason for consultation during pregnancy. In early pregnancy (0–18 days), drugs that affect cell division (e.g. WE NEED YOUR HELP! No scientific studies have investigated the chance of stillbirth following use of carbimazole or methimazole in pregnancy. A large number of case reports (>70) and numerous case-control and cohort studies have linked exposure to carbimazole/methimazole (CMZ/MMI) during early pregnancy with an embryopathy that incorporates a number of birth defects including aplasia cutis, choanal atresia, gastrointestinal anomalies and abdominal wall defects. nfoulds@sghms.ac.uk Concerns about the safety of carbimazole in pregnancy were raised in 1985. No links between carbimazole or methimazole use in pregnancy and miscarriage were shown in either of two small studies but more research is required to confirm this finding. Following absorption, carbimazole is rapidly and completely metabolised to methimazole, which inhibits the synthesis of the thyroid hormones thyroxine (T4) and triiodothyronine (T3). QJM 2012; 105:189. The pregnancy rate was 33.3% in treated women compared to 8.4% in the placebo group (p = 0.03). 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. My son was born at full term with no … It has (rarely) been associated with congenital defects, including aplasia cutis of the neonate but is not contra-indicated. Placental transfer of the active metabolite of carbimazole can produce neonatal hypothyroidism, but propylthiouracil does not transfer in large enough quantities to cause problems. Carbamazepine has been viewed by many as the antiepileptic drug (AED) of choice during pregnancy, 1 as there are more studies on the fetal outcomes associated with in utero CBZ monotherapy compared with other AEDs. The most common causes of hyperthyroidism during pregnancy are Graves’ diseaseand hCG-mediated hyperthyroidism such as gestational transient hyperthyroidism, hyperemesis gravidarum (intractable … Carbimazole is associated with an increased risk of congenital malformations, especially when administered in the first trimester of pregnancy and at high doses. Therefore, carbimazole should be used in pregnancy only when propylthiouracil is not suitable. Most medicines used by the mother will cross the placenta and reach the baby. Carbimazole is used to treat an overactive thyroid gland (hyperthyroidism). The prevalence of hyperthyroidism (overactive thyroid) during pregnancy ranges from 0.05 to 0.2%. Risk with carbimazole. You will need to have regular blood tests. Traditionally, MMI has been considered to have clearer evidence of teratogenicity than PTU. The MHRA said an EU review of evidence from epidemiological studies and case reports showed that carbimazole is associated with an increased risk of congenital malformations when used during pregnancy, especially during the first trimester and at high dosages (≥15mg daily). None of the 12 infants, including one set of twins, had a serum thyroxine (T4) concentration below the lower limit of normal on day 4 of life. The risk is higher with the use of Methimazole. If carbimazole is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended (see section 4.4). However, in Graves' disease the thyroid-stimulating antibody crosses the … Many of these conditions are common in women of fertile age and can have a profound impact on fertility and pregnancy outcome if they are not managed optimally. Because this drug crosses the placenta and can induce goiter and cretinism in the developing fetus, excessive doses should not be given during pregnancy. Lancet 1992; 339:742. Whilst every effort will be made to ensure that this information is accurate and up to date at the time of publication, we cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes following decisions made on the basis of this information. Do not make any change to your medication without first talking to your doctor. If you have any questions regarding the information in this leaflet please discuss them with your health care provider. Close maternal, fetal and neonatal monitoring is warranted (see section 4.6 Fertility, pregnancy and lactation). Carbimazole: increased risk of congenital malformations. It is currently unclear whether taking carbimazole or methimazole in pregnancy is linked to low birth weight in the baby because the results of the studies that have investigated this do not all agree. Carbimazole does cross the placenta and there have been rare instances of babies born with nail/finger abnormalities (aplasia cutis) while on carbimazole. Methimazole, carbimazole, and congenital skin defects. … These are referred to as the background population risks. In a Drug Safety Update, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning about the increased risk of congenital malformations with the use of carbimazole during pregnancy. Reference: MRHA (February 2019). Bowman P, Vaidya B. 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. Due to the possible risk of CMZ/MMI embryopathy, hyperthyroidism in pregnancy is often treated with propylthiouracil (PTU). It is therefore possible that taking certain medicines at any stage of pregnancy could have a lasting effect on a child’s learning or behaviour. If carbimazole is used during pregnancy, the lowest effective dose without additional administration of thyroid hormones should be administered. Finally, a number of case reports have linked in utero CMZ/MMI exposure to developmental delay in children, most of whom had structural birth defects. You will receive an email when new content is published. Maternal hyperthyroidism should be treated with titrated doses of antithyroid drugs, as block-and-replace regimes result in fetal hypothyroidism since thyroxine cannot easily cross the placenta. In many women, thyroid dysfunction diminishes as the … The lowest dose possible should be used, and this can often be discontinued three to four weeks before term, in order to reduce the risk of neonatal complications. Carbimazole and methimazole use in early pregnancy appears to occasionally cause certain birth defects in the baby. Carbimazole (Neo-Mercazole®) and the related medicine methimazole are antithyroid medicines used to treat women with an overactive thyroid gland (hyperthyroidism). Use of carbimazole in pregnancy, especially during the first trimester, and at doses greater than 15mg per day, is associated with an increased risk of congenital malformations. To have your say on how we can improve our website and the information we provide please visit here. This document is regularly reviewed and updated. Carbimazole should be used judiciously in pregnancy as it crosses the placenta. Thyroid diseases are among the most common endocrine disorders encountered during pregnancy. Where exposure to CMZ/MMI has occurred in the first trimester, a routine 20-week anomaly scan should be offered, although it should be noted that some CMZ/MMI-associated defects would be unlikely to be detected. When I fell pregnant with my second it wasn’t so planned and I was still taking carbimazole at the time of conception and up until around 8 weeks when I discovered I was pregnant. However, an overactive thyroid in pregnancy has been linked to low birth weight in the baby and this may explain why some studies have found that babies of pregnant women taking carbimazole or methimazole tended to be smaller. 4.5 Interaction with other medicines and other forms of interaction Little is known about interactions. Use of carbimazole in pregnancy, especially during the first trimester, and at doses greater than 15mg per day, is associated with an increased risk of congenital malformations. Asher Ornoy, Corinna Weber-Schöndorfer, in Drugs During Pregnancy and Lactation (Third Edition), 2015. It has (rarely) been associated with congenital defects, including aplasia cutis of the neonate but is not contra-indicated. Features of fetal hyper- and hypothyroidism (goitre, tachycardia, hydrops, bone maturity) can also be detected on serial scanning. This should be offered to all women. if carbimazole is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended. Q: Will the consumption of NeoMercazole medicine before and during pregnancy affect the pregnancy test and the unborn baby? For case-specific advice please contact UKTIS on 0344 892 0909. Eleven mothers were taking oral carbimazole in dosages ranging from 5 to 20 mg daily during pregnancy and 5 to 15 mg daily during breastfeeding (extent not stated). 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. Fast Home Delivery with COD No Minimum Order Flat 18% … The lowest dose possible should be used, and this can often be discontinued three or four weeks before term, in order to reduce the risk of neonatal complications. Carbimazole and methimazole are thionamide antithyroid agents used in the management of hyperthyroidism and licensed for the treatment of Graves’ disease, in the preparation of hyperthyroid patients for thyroidectomy, and as an adjunct to radioiodine therapy. UKTIS is a not-for-profit organisation funded by Public Health England on behalf of UK Health Departments. 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. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. 2. First, the increased possibility of congenital malformations if taken when pregnant. Last edited 03/2019. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the Bumps website. J Thyroid Res 2011; 2011:235130. What you need to know before you take Warnings and precautions can cause harm to an unborn baby. Traditionally, MMI has been considered to have clearer evidence of teratogenicity than PTU. Carbimazole (Neomercazole) is converted into methimazole after it is absorbed. Keep your regular appointments with your doctor so that your condition can be monitored and any dose adjustments can be made. Ann Intern Med 1987; 106:60. Carbimazole embryopathy: an emerging phenotype. March 12, 2019. Nevertheless, fetal abnormalities are more commonly produced by drugs that are administered during organogenesis (2–8 weeks). When deciding whether or not to take carbimazole during pregnancy your doctor will help you to weigh up how necessary carbimazole is to your health against the possible risks to you or your baby, some of which will depend on how many weeks pregnant you are. This is a UKTIS monograph for use by health care professionals. For some women carbimazole or methimazole may be considered the best medicines to maintain normal thyroid function during pregnancy. fewer than after PTU use). Login to my bumps There is weak scientific evidence to suggest that exposure to CMZ/MMI in utero is linked to lower birth weight, but data are limited and likely to be confounded by factors relating to maternal hyperthyroidism. Thiamazole (methimazole) and carbimazole. If you are trying to conceive you should speak to your doctor who may suggest that you change to a different medicine. Close maternal, foetal and neonatal monitoring is warranted (see Section 4.6 Fertility, pregnancy and lactation, Use in pregnancy). Antithyroid drug treatment of hyperthyroidism in pregnant women is controversial because the usual drugs—methimazole or carbimazole—are occasionally teratogenic; and the alternative—propylthiouracil—can be hepatotoxic. Carbimazole is used for hyperthyroidism and other conditions. If you are on regular medication you should discuss these effects with your doctor/health care team before becoming pregnant. The potential risks and benefits of PTU over CMZ should be made on an individual patient basis. Newborn babies of women with Graves’ disease may also experience other thyroid problems. Carbimazole and methimazole use in early pregnancy appears to occasionally cause certain birth defects in the baby. Methimazole Uses: ... Pregnancy Risk Factor D. Methimazole can cross the placenta. Significant published evidence of safety with carbimazole and its active metabolite, methimazole No adverse effects reported in infants at doses of 30mg daily Monitoring the infant’s thyroid function should be considered, especially in newborn infants, although no cases of … If carbimazole is used during pregnancy, the lowest effective dose without additional administration of thyroid hormones should be administered. Bowman P, Osborne NJ, Sturley R, Vaidya B. Carbimazole embryopathy: implications for the choice of antithyroid drugs in pregnancy. However, none of four small scientific studies have shown that children exposed to carbimazole or methimazole in the womb are more likely to have problems with learning and behaviour than children not exposed to these medicines. 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